Career Opportunities

Roles and Responsibilities for the Position

• Run weekly in vitro ADME (absorption, distribution, metabolism and excretion) assays to guide chemistry structure-activity relationships (SAR)
• Analyze in vitro samples utilizing LC-MS/MS
• Participate in the management of CROs in the conduct of in vitro ADME studies
• Develop, and validate novel ADME screens
• QC in vivo protocols and study reports
• Collate data and present to program team
• Contribute to authoring and review of regulatory reports and documents
• Maintain accurate and timely electronic lab notebook
• Work effectively both independently and in a team environment

Required Qualifications and Background

• BS or MS degree in pharmacology, biochemistry or related discipline
• 2-6 years of laboratory experience
• 1+ year LC-MS/MS experience (Sciex systems preferred)
• Experience with bioanalysis method and assay development
• Good written and oral presentation capabilities
 
Loxo Oncology, Inc. (Loxo) currently anticipates that the base salary for the Associate Scientist level could range from between $59,000 to $86,577 and that the base salary for the Scientist level could range from between $78,000 to $114,498 will depend, in part, on the successful candidate’s qualifications for the role, including education and experience. This position will also be eligible for a company bonus (depending, in part, on company and individual performance).  In addition, Loxo provides a comprehensive benefit program to eligible employees, including vacation, medical, dental and vision benefits; participation in a 401(k) plan; life and accidental death and disability coverage; parental leave benefits and employee discounts for certain items.  The compensation described above is subject to change and could be higher or lower than the range described above. Further, Loxo reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion.

Roles and Responsibilities for the Position

• This position will support our Biostatistics Leader along with some other key team members.  This individual interacts with internal contacts at all levels of the Loxo and Lilly Oncology organization as well as a diverse group of important external partners and vendors. Independent judgment is required to plan, prioritize and organize a diversified workload and recommend improvements in office practices or procedures.


Responsibilities include:
• Provide administrative support including heavy calendar management and cross functional meeting coordination, travel and expense management, as well as other administrative tasks.
• Answer non-routine correspondence and assemble highly confidential and sensitive information.
• Assist with other special projects as needed, including assisting with external vendor coordination and support for Discovery programs/projects.
• Coordinate and facilitate the use of conference rooms for team and vendor meetings.
• Greet on-site visitors and work closely with the team to ensure meetings remain on schedule.

Required Qualifications and Background

• Minimum of 5+ years in a comparable Administrative Support role with a preference for experience within the Biotech or Pharma environment.
• Positive, eager and helpful attitude.
• Professional demeanor and excellent written and verbal communication skills.
• Able to work within a fast-paced environment, adept at juggling multiple tasks and priorities and prioritizing independently.
• Enthusiastic, self-motivated and keen to improve processes and overcome inefficiencies.
• Effective collaborator with a variety of stakeholders, thoughtful listener and team player.
• Able to maintain a calm, patient and “can-do” approach.
• Conscientious, detail-oriented, well-organized and takes initiative to anticipate and address needs.
• Able to bring a proactive and creative approach to problem solving.
• Proficient in Microsoft Office suite and applications.
Please note: Post COVID, this role requires an on-site presence from 8:30am-5pm, Monday to Friday.

Roles and Responsibilities of the Position

• Lead cross-functional teams that will be responsible for novel target discovery and validation including Discovery Biology team members in SSF and NYC
• Supervise and mentor PhD and non-PhD scientists engaged in target identification and validation to think deeply and work creatively while delivering excellent scientific results and insights to the project teams and their colleagues
• Develop and implement strategies that will enable Discovery Biology team members to continually advance internal drug development efforts through our discovery, clinical and research programs
• Innovate technologies and methods to advance our discovery projects particularly in the area of gene editing/functional genomics and or chemical biology
• Engage leaders across Loxo Oncology at Lilly to identify, credential, and advance new targets and serve as a liaison for the Discovery Biology team and the company at large
• Contribute to due diligence evaluation of external opportunities
• Mentor post-doctoral fellows

Required Qualifications and Background

• PhD in systems biology, molecular & cellular biology, chemical biology, or related field
• Minimum of 5-10 years research experience following post-doctoral training with prior experience in target discovery/credentialing and cancer biology in the biotech or pharma setting
• Extensive experience in the areas of cancer biology and cancer genomics
• Demonstrated track record of success in leveraging functional genomics or chemical biology platforms
• Demonstrated evidence for the ability to partner with computational biologists to leverage systems-scale datasets
• Expertise in designing and commissioning studies using a variety of research tools in cancer cell lines and murine models of cancer
• Experience in leading PhD level scientists
• Outstanding communication, writing, and presentation skills is a must
• Highly organized with excellent analytical, documentation and multi-tasking skills
• Provide strategic input to target identification and validation strategy to leadership team
• Ability to collaborate, lead, and influence others

Additional Preferred Qualifications

• Hands on experience executing functional genomics screens or deploying chemical biology tools
• Experience working with external CROs to optimize internal/external resources




Loxo Oncology, Inc. (Loxo) currently anticipates that the base salary for the Associate Director position level could range from between $135,300 to $198,516 and will depend, in part, on the successful candidate’s qualifications for the role, including education and experience. This position also will be eligible for a company bonus(depending, in part, on company and individual performance).  In addition, Loxo provides a comprehensive benefit program to eligible employees, including vacation, medical, dental and vision benefits; participation in a 401(k) plan; life and accidental death and disability coverage; parental leave benefits and employee discounts for certain items.  The compensation described above is subject to change and could be higher or lower than the range described above. Further, Loxo reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion.

Roles and Responsibilities of the Position

• Design and oversee the execution of key mechanistic and discovery biology experiments involving diverse oncogenic mechanisms (i.e., tumor indications, signaling, cancer targets, biologic mechanisms of tumor inhibitions).
• Design and execute a scientific research discovery program from idea development to IND filing.
• Maintain focus on project deliverables and prioritize experiments and efforts accordingly.
• Oversee/perform assays to identify the drug candidate evaluate the candidate for clinical testing.
• Liaise with CROs and vendors to outsource activities, provide input to management team on vendor selection.
• Provide scientific expertise when determining organizations to strategically partner with.
• Interrogate experimental conduct of third parties/vendors.
• Participate in target identification in collaboration with leadership.
• Build, lead, and manage team of Scientists at various levels.  
• Indirectly oversee work of third parties/vendors (e.g., CROs).
• Manage resource allocation effectively.
• Build roadmaps to execute on specific targets, and overall strategic projects.

Required Qualifications and Background

• PhD in cellular biology, immunology, or allied disciplines with minimum 3+ years’ industry experience OR BS/MS with 10+ years of direct pharmaceutical/biotechnology experience.
• Laboratory experience with ADC and TCE platforms highly preferred
• Knowledge of immunology and/or cancer signaling biology experience
• Strong attention to detail and highly goal oriented with demonstrated critical thinking capabilities.
• Ability to trouble shoot effectively and think outside of the box.
• Ability to collaborate with translational biology functions (PK/PD, toxicology, Ab discovery).
• Proven success leading, managing, and coaching others (either directly or indirectly).
• Demonstrated ability and track record in managing work overseen by third parties/vendors/strategic partners.
• Demonstrated experience in working collaboratively across various scientific disciplines to meet end goals of business.
• Demonstrated excellence in making key strategic decisions in support of broader business goals.
• Excellent written and verbal communication skills.




Loxo Oncology, Inc. (Loxo) currently anticipates that the base salary for the Associate Director position level could range from between $135,300 to $198,516 and will depend, in part, on the successful candidate’s qualifications for the role, including education and experience. This position also will be eligible for a company bonus(depending, in part, on company and individual performance).  In addition, Loxo provides a comprehensive benefit program to eligible employees, including vacation, medical, dental and vision benefits; participation in a 401(k) plan; life and accidental death and disability coverage; parental leave benefits and employee discounts for certain items.  The compensation described above is subject to change and could be higher or lower than the range described above. Further, Loxo reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion.

Roles and Responsibilities of the Position:

• Oversee a team of GMP Quality personnel
• Ensure GMP work at Loxo and contract organizations is done in compliance with applicable laws, regulations, guidelines, and SOPs.
• Work closely with Loxo QA, CMC, Regulatory, and Drug Supply colleagues through all phases of drug development, particularly early phase to ensure compliance and timeliness of GMP work.
• Work closely with CMOs to ensure compliance and timeliness of GMP work.
• Execute all Quality System elements, which include but are not limited to investigation of product complaints, deviations, CAPAs, document creation and control, change control, validation (e.g. analytical method,.), stability, batch record review, specifications, expiry extensions, and product disposition.  
• Work with CMO to negotiate Quality Agreements
• QC Regulatory documents (e.g. IMPD/IND/Marketing Authorization) CMC sections.
• Facilitate documentation reviews with Qualified Persons (QPs)
• Review and approve labeling. 
• Participate on project teams and sub-teams as needed and assigned. 
• Ensure documents and records are kept in compliance with regulations and SOPs. 
• Author/Revise SOPs and drive process improvements.
• Additional tasks as required.

Required Qualifications and Background:

• BA/BS in science or engineering. 
• A minimum of 12-15 years of experience working in the Biotech or Pharmaceutical FDA regulated industry in QA or a related area such as QC or CMC.
• 5-7 years People management experience
• Experience with QP requirements related to Product Release of Clinical phase products.
• Experience partnering with Clinical Supply Teams for Release and Shipping of product.
• Experience in Batch Review and Release for clinical phase products.
• Experience writing and reviewing and approving Deviations, CAPAs, and Change Controls.
• Experience working with small molecule (e.g. solid oral dosage products) and/or Biologics.
• Working knowledge of cGMP’s (e.g. CFR/ICH/EU) and applicable international regulations/guidelines.
• Experience working with Contract Manufacturing Organizations.
• Strong understanding of GMP requirements for early phase drug development.
• Exceptional attention to detail and accuracy of work.
• Ability to multitask and work in a fast-paced environment to meet tight deadlines.
• Strong problem-solving skills and ability to lead process improvements
• Strong leadership skills and the ability to lead cross functional meetings and make decisions
• Quality and business knowledge to determine when to escalate issues when necessary
• Ability to work in a matrixed environment.
• Ability to work in a virtual manufacturing environment.
• Ability to travel both domestic and internationally.
• Demonstrated ability to work well with other accomplished professionals at all levels of the organization.
• Strong internal and external collaborator.
• Strong communication skills both written and oral.

Roles and Responsibilities for the Position

• Oversee the proper and timely collection and reporting of AE information from all sources.
• Assist in the preparation and management of aggregate safety reports (e.g. IND safety reports, DSURs, PSLLs etc.).
• Perform medical review of AEs/SAEs from clinical trials, interfacing with reporters as needed.
• Provide support for safety sections of clinical documents, including the review and approval of the safety portion of protocols, ICFs, CSRs, IBs and other documents as needed.
• Review of protocols, case report forms, guidelines, CSRs and manuscripts as requested.
• Assist with the development and maintenance of pharmacovigilance related SOPs, policies and work instructions.
• Create and track case processing metrics for internal monthly safety reports.
• Contribute to regulatory authority submissions by reviewing safety data and assisting in the preparation of relevant sections.
• Participate in regulatory and inspections/audits as it relates to pharmacovigilance activities.
• Collaborate cross functionally with other departments including clinical, biostatistics, data management, clinical operations and regulatory affairs with respect to safety related issues.
• Liaise to provide drug safety oversight of processes overseen by vendors.
• Participate in addressing drug safety-related questions from Regulators or to support Company internally.
• Other duties may be assigned. 

Required Background and Qualifications

• Health science degree: Nursing (RN, BSN, MSN or NP),  RPH, PharmD, PA or MD.
• Minimum of 7 years of experience in the pharmaceutical industry or CRO, with 5 years in drug safety, pharmacovigilance and risk assessment or relevant experience.
• Experience in the management of safety information originating from clinical trials and post-marketing sources.
• Experience in Hematology/Oncology desired.
• Experience and working knowledge of Good Pharmacovigilance Practices (GPvP)required.
• Knowledge of U.S. and International Regulatory Reporting Requirements for Product Safety, and of the clinical development process.
• Working knowledge of relevant regulations and guidance documents governing both safety reporting and processing for both clinical trial and post-marketing environments.
• Ability to interpret scientific and clinical trial data.
• Strong verbal and written communications and presentation skills.
• Proven problem solving, decision-making and interpersonal skills.
• Detailed knowledge of drug safety databases.
• Expertise working with MedDRA.
• Possess strong leadership skills and the ability to compile and disseminate information to others in a cohesive fashion to assure a clear understanding of project status and direction.
• Proficiency in MS Office Suite.
• Strong ability to prioritize tasks and keen attention to detail.
• Ability to be both enterprising and resourceful.
• Proven ability to work on multiple projects in a fast-paced environment.
 
Loxo Oncology, Inc. (Loxo) currently anticipates that the base salary for the Associate Director level position could range from between $135,300 to $198,516 and will depend, in part, on the successful candidate’s qualifications for the role, including education and experience. This position will also be eligible for a company bonus (depending, in part, on company and individual performance).  In addition, Loxo provides a comprehensive benefit program to eligible employees, including vacation, medical, dental and vision benefits; participation in a 401(k) plan; life and accidental death and disability coverage; parental leave benefits and employee discounts for certain items.  The compensation described above is subject to change and could be higher or lower than the range described.

Available Locations for the Role

• South San Francisco, CA
• Indianapolis, IN
• Stamford, CT
• US Based-Remote

Roles and Responsibilities of the Position

• Lead the biostatistics function to develop and execute statistical strategy, design and analyses for clinical pharmacology trials across portfolio.
• Ensure the use of appropriate statistical methodologies and its clear communication in a cross functional setting.
• Oversee and collaborate with statistical analysis vendors and consultants as needed.
• Maintain transparent communication with vendors and partners enabling timely and quality deliverables.
• Provide support and instructions for derivations and analyses for clinical pharmacology studies to statistical programming as appropriate to ensure quality of deliverables.
• Develop statistical programs as necessary to perform analyses, prepare data displays and verify the correctness of data and analyses.
• Help design data capture methods and select appropriate study endpoints for clinical pharmacology studies.
• Contribute to establishing and maintaining policies, procedures, and standards within the biostatistics department and in cross functional teams as appropriate.

Required Qualifications and Background

• PhD with minimum 8 years OR master’s with minimum 10 years of experience in statistics/biostatistics/related field is required
• Minimum 3 years of clinical pharmacology studies experience in the pharmaceutical/biotech industry is required
• Strong knowledge of clinical trial design, drug development regulations pertinent to statistical analysis, and sound understanding of statistical applications for clinical pharmacology studies is required
• Familiarity with common PK modelling approaches is preferred (although implementation is not part of the responsibilities) and can be part of training
• Previous NDA/BLA/MAA experience is preferred.
• Proficient SAS programming skills and solid understanding of CDISC models and standards
• Ability to plan, develop timelines, multi-task, and shift priorities rapidly to meet tight deadlines.
• Excellent writing and communication skills along with demonstrated leadership abilities and excellent interpersonal skills.

Available Locations for the Role

• South San Francisco, CA
• US Based-Remote




Loxo Oncology, Inc. (Loxo) currently anticipates that the base salary for this position level could range from between $135,300 to $198,516 and will depend, in part, on the successful candidate’s qualifications for the role, including education and experience. This position will also be eligible for a company bonus(depending, in part, on company and individual performance).  In addition, Loxo provides a comprehensive benefit program to eligible employees, including vacation, medical, dental and vision benefits; participation in a 401(k) plan; life and accidental death and disability coverage; parental leave benefits and employee discounts for certain items.  The compensation described above is subject to change and could be higher or lower than the range described above. Further, Loxo reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion.

Roles and Responsibilities

• Assist in evaluation and purchase of capital equipment for establishment of the compound management operation and implement plans for long term instrument maintenance.
• Develop, maintain, and improve sample workflows associated with storage, manual neat/weigh operations, liquid handling,  and delivery of samples to internal and external teams.
• Develop tools to simplify internal processes and improve user experience.
• Manage processes associated with international and domestic shipments between collaborators and research sites, ensuring proper documentation is maintained.
• Establish/Maintain a generative safety culture and ensure adherence to safety policies.
• Serve as a steward for the physical compound inventory as well as the associated inventory/output data.
• Test/Validate changes to software, hardware, and procedures. Proactively seek improvements to usability of these systems and production timelines.
• Create and maintain SOPs and job aids for critical processes.
• Troubleshoot software and hardware issues and resolve sample dispensing issues raised by customers.
• Assist laboratory technicians with day-to-day responsibilities, ensuring projects are supported in a timely, consistent manner.
• Establish processes for replenishment of consumables.
• Track production metrics to quantify required changes and subtle operational issues.
• Maintain effective oral and written communication to Discovery team members and provide support to ensure timelines are met.
• Maintain customer-focused attitude and operation.
• Provide additional support to the Discovery Team as requested.

Required Qualifications and Background

• A BS/MS or equivalent degree in chemical, biological, engineering sciences or related fieldwith 5+ years working full time in a laboratory setting either in academia or industry.
• Experience programming and maintaining laboratory instruments/automation related to compound management (e.g., storage systems, balances, traditional and acoustic liquid handlers)
• Experience maintaining an inventory of neat and solubilized samples.
• Experience with inventory/request database systems for compound and/or biological sample management (LIMS).
• Strong organizational skills and attention to detail.
• Ability to work both independently and within a multidisciplinary team.
• Excellent written, verbal, and interpersonal communication skills are required, with ability to work with/across a range of disciplines including biology, medicinal chemistry and bioassay.


Additional Skills:
• Experience with software and hardware components of relevant automation platforms: Echo/Access, Tecan, Hamilton Storage and/or Liquid Handling.
• Experience with automation controlling software such as Green Button Go or similar.
• Experience with SQL or other programming experience.
• Experience shipping/receiving both domestically and internationally.




Loxo Oncology, Inc. (Loxo) currently anticipates that the base salary for this position could range from between $78,000 to $114,498 and will depend, in part, on the successful candidate’s qualifications for the role, including education and experience. This position will also be eligible for a company bonus(depending, in part, on company and individual performance).  In addition, Loxo provides a comprehensive benefit program to eligible employees, including vacation, medical, dental and vision benefits; participation in a 401(k) plan; life and accidental death and disability coverage; parental leave benefits and employee discounts for certain items.  The compensation described above is subject to change and could be higher or lower than the range described above. Further, Loxo reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion.

Roles and Responsibilities of the Position

• Coordinate with Loxo Discovery Biology team members and facilities to understand the overall scope for each lab and work directly with  relevant team members to gather, revise, finalize and ensure delivery of the lab requirements (and associated documents) to the lab construction lead coordinators.
• Actively engage in preparing lab equipment list and coordinate with internal and external resources to finalize and manage all changes to the list.
• Actively engage in identifying equipment vendors and liaise in enabling purchase and delivery of the equipment to the SSF or NYC site.
• Coordinate with SSF or NYC internal Facilities to actively monitor the overall progress of the lab build up to ensure alignment with the agreed upon lab build up plan.
• Actively engage in operationalizing SSF or NYC Loxo Discovery Biology labs.
• Facilitate in understanding lab ordering needs and coordinate with Loxo operations to create/extend existing procurement set up.
• Lead in ordering and stocking up all lab reagents and materials once the labs are commissioned and maintain inventory to meet the labs’ daily operational needs.
• Lead in setting up lab management processes, create necessary documentation, and manager user training to the lab personnel.
• Contribute to cell line expansion, authentication, and banking.
• Facilitate in managing day-to-day lab operational activities by coordinating with different team members to ensure the stated set up is appropriate.
• Apply creative problem solving and resourcefulness to navigate through unknown events, able to find solution with moderate supervision.
• Adaptive to change in priorities and able to navigate through identifying and managing the changes effectively.
• Able to effectively communicate and navigate through technical and non-technical audiences across cross-functional departments within the company, vendors, and external collaborators.
• Contribute to building positive, collaborative teams across various scientific disciplines and encouraging sharing of new ideas, and creative ways to problem solving. 

Required Qualifications and Preferred Background

• 5+ years of Biotech and Pharmaceutical industry experience in working in the scientific field with up to 2 years of lab management experience, and a bachelor’s degree or advanced degree in relevant scientific fields (e.g., biology) required. Experience in working with diverse set of scientific environments and able to execute requests with moderate supervision
• Clearly understand the distinction between high-level scope and day-today operations
• Comfortable in collaborating with the vendors
• Good verbal, written communication, and interpersonal skills
• Excellent organizational skills, efficient, with strong attention to detail
• Ability to anticipate problems and proactively propose solutions
• Experience with standard tissue culture protocols.
• Proficient in MS Office suite 

Available locations for this role

• South San Francisco, CA
• New York City, NY




Loxo Oncology, Inc. (Loxo) currently anticipates that the base salary for the Associate Scientist position level could range from between $59,000 to $86,577 and will depend, in part, on the successful candidate’s qualifications for the role, including education and experience. This position also will be eligible for a company bonus(depending, in part, on company and individual performance).  In addition, Loxo provides a comprehensive benefit program to eligible employees, including vacation, medical, dental and vision benefits; participation in a 401(k) plan; life and accidental death and disability coverage; parental leave benefits and employee discounts for certain items.  The compensation described above is subject to change and could be higher or lower than the range described above. Further, Loxo reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion.

Roles and Responsibilities for the Position

• Drive the team forward with new medicinal chemistry analogs that consistently move the project toward the next breakthrough drug candidate.
• Optimize lead series for potency, selectivity, physiochemical properties, in vitro ADME, and PK by coupling multivariate SAR analysis with hypothesis-driven medicinal chemistry design principles.
• Work closely with structural biology and computational chemistry colleagues to design novel compounds and hypotheses that address key drug optimization goals.
• Reduce ideas to practice in the lab quickly by effectively employing a broad range of modern organic chemistry transformations, synthetic methods, purification and characterization techniques.
• Synergize with the broader team by communicating results, sharing insights, making plans, and setting goals in an open, honest way.

Required Qualifications and Background

• B.S. with 5+ years, M.S. with 3+ years, or Ph.D. with 0-1 years’ experience with a focus on synthetic organic chemistry or experience in small molecule organic synthesis and/or drug discovery experience in a biotechnology or pharmaceutical setting.
• Proficiency in modern synthetic methodology and variable reaction scales.
• Ability to design feasible synthetic routes to target molecules and choose appropriate reaction conditions.
• Skilled user of synthetic chemistry instrumentation: HPLC, LC-MS, NMR, and purification systems.
• Experience in lead compound optimization for potency, selectivity, ADME and PK is preferred but not required.
• Experience in using common synthetic chemistry software: electronic notebook, ChemDraw, Excel, literature search engines.
• An excellent team player with ability to communicate synergistically with a multidisciplinary team. Highly organized with excellent analytical, documentation, time management, and multi-tasking skills.
 
Loxo Oncology, Inc. (Loxo) currently anticipates that the base salary for the Associate Scientist level could range from between $59,000 to $86,577 and that the base salary for the Scientist level could range from between $78,000 to $114,498 will depend, in part, on the successful candidate’s qualifications for the role, including education and experience. This position will also be eligible for a company bonus (depending, in part, on company and individual performance).  In addition, Loxo provides a comprehensive benefit program to eligible employees, including vacation, medical, dental and vision benefits; participation in a 401(k) plan; life and accidental death and disability coverage; parental leave benefits and employee discounts for certain items.  The compensation described above is subject to change and could be higher or lower than the range described above. Further, Loxo reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion.

Roles and Responsibilities of the Position:

• Provide recombinant protein expression, expression QC, small scale purification for multiple projects, simultaneously, within the protein sciences group to provide high quality proteins to structural biology & enzymology.
• Execute projects in an efficient manner, working within aggressive timelines.
• Rapidly communicate/record scientific results and insights to the team.
• Prepare reports for internal and external purposes including regulatory submissions.
• Participate and lead project-based and technical team meetings to identify and solve problems, guide work towards project goals, communicate on-going work and progress, and plan forward thinking strategies.
• Continually advance your understanding of current methodology and new/emerging technologies by reading scientific literature.
• Proactively investigate new or different technologies, methods, and service providers to ensure our work is being done in a scientifically sound, efficient, and reasonable way.

Required Qualifications and Preferred Background:

• A/BS/MS/PhD in biology, biosciences, genetics, biochemistry, molecular biology or a related field.
• Ideal candidate will have with 2+ years hands-on experience, working in a gene to structure laboratory in a biotech/pharma setting, but less experienced, motivated individuals are encouraged to apply.
• Experience with a variety of protein expression systems (E.coli baculovirus-infected insect cells, mammalian) for recombinant protein expression. Hands-on experience of a variety of insect cell cells (Sf9, Sf21, T.ni/Hi5) from culture, transformation/transfection and characterization is desirable.
• Experience with small scale analysis from E. coli and Bv expression systems, particularly regarding soluble protein expression.
• Ability to multi-task for parallel processing of multiple samples, both small-scale and large-scale.
• Hands-on experience of protein purification techniques such as IMAC, SEC, IEX are desirable.
• SDS-PAGE, Western Blot, Cell Counter experience as well as experience of modern cloning techniques such as Gibson Assembly is a plus.
• The candidate must be self-motivated but always maintain focus on why we are here and who is important i.e. the patients and their families/caregivers.
• Excellent interpersonal skills with ability to communicate and interact well with colleagues, vendors, contractors, scientific advisors, and staff at all levels.
• Highly organized with excellent analytical, documentation and multi-tasking skills.
• Experience across the gene-to-structure pipeline is a plus.
• A learning mindset.  


Loxo Oncology, Inc. (Loxo) currently anticipates that the base salary for the Associate Scientist level could range from between $59,000 to $86,577 and that the base salary for the Scientist level could range from between $78,000 to $114,498 will depend, in part, on the successful candidate’s qualifications for the role, including education and experience. This position will also be eligible for a company bonus (depending, in part, on company and individual performance).  In addition, Loxo provides a comprehensive benefit program to eligible employees, including vacation, medical, dental and vision benefits; participation in a 401(k) plan; life and accidental death and disability coverage; parental leave benefits and employee discounts for certain items.  The compensation described above is subject to change and could be higher or lower than the range described above. Further, Loxo reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion.

Roles and Responsibilities of the Position

• Provide recombinant protein expression, expression QC, small scale purification for multiple projects, simultaneously, within the protein sciences group to provide high quality proteins to structural biology & enzymology.
• Execute projects in an efficient manner, working within aggressive timelines.
• Rapidly communicate/record scientific results and insights to the team.
• Prepare reports for internal and external purposes including regulatory submissions.
• Participate and lead project-based and technical team meetings to identify and solve problems, guide work towards project goals, communicate on-going work and progress, and plan forward thinking strategies.
• Continually advance your understanding of current methodology and new/emerging technologies by reading scientific literature.
• Proactively investigate new or different technologies, methods, and service providers to ensure our work is being done in a scientifically sound, efficient, and reasonable way.

Required Qualifications and Backgroun

• BA/BS/MS/PhD in biology, biosciences, genetics, biochemistry, molecular biology or a related field.
• Ideal candidate will have with 2+ years hands-on experience, working in a gene to structure laboratory in a biotech/pharma setting, but less experienced, motivated individuals are encouraged to apply.
• Experience with a variety of protein expression systems (E.coli baculovirus-infected insect cells, mammalian) for recombinant protein expression. Hands-on experience of a variety of insect cell cells (Sf9, Sf21, T.ni/Hi5) from culture, transformation/transfection and characterization is desirable.
• Experience with small scale analysis from E. coli and Bv expression systems, particularly regarding soluble protein expression.
• Ability to multi-task for parallel processing of multiple samples, both small-scale and large-scale.
• Hands-on experience of protein purification techniques such as IMAC, SEC, IEX are desirable.
• SDS-PAGE, Western Blot, Cell Counter experience as well as experience of modern cloning techniques such as Gibson Assembly is a plus.
• The candidate must be self-motivated but always maintain focus on why we are here and who is important i.e. the patients and their families/caregivers.
• Excellent interpersonal skills with ability to communicate and interact well with colleagues, vendors, contractors, scientific advisors, and staff at all levels.
• Highly organized with excellent analytical, documentation and multi-tasking skills.
• Experience across the gene-to-structure pipeline is a plus.
• A learning mindset.  


Loxo Oncology, Inc. (Loxo) currently anticipates that the base salary for the Associate Scientist level could range from between $59,000 to $86,577 and that the base salary for the Scientist level could range from between $78,000 to $114,498 will depend, in part, on the successful candidate’s qualifications for the role, including education and experience. This position will also be eligible for a company bonus (depending, in part, on company and individual performance).  In addition, Loxo provides a comprehensive benefit program to eligible employees, including vacation, medical, dental and vision benefits; participation in a 401(k) plan; life and accidental death and disability coverage; parental leave benefits and employee discounts for certain items.  The compensation described above is subject to change and could be higher or lower than the range described above. Further, Loxo reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion.

Roles and Responsibilities of the Position

• Handling multiple cell cultures simultaneously
• Develop robust cell-based assays
• Design, execute, and troubleshoot high quality experiments
• Apply and execute various assay platform including HTRF, ELISA, ICW, MSD, and CTG
• Perform comprehensive and robust data analysis
• Regularly communicate experimental findings to team members
• Operate, implement, and troubleshoot laboratory automation
• Actively engaged in advancing oncology drug discovery programs
• Works and communicates well with team members across functional areas daily

Required Qualifications and Background

• BS/MS in biology, biochemistry, or related fields OR PhD in biology, biochemistry with 0 years of postdoctoral/industry experience
• 2-8 years of experience culturing cells and performing cell assays in biotech or a pharma environment
• A scientific foundation in the understanding and implementation of a wide range of cell-based screening assays and readouts
• Highly organized with excellent analytical and documentation skills
• Great attention to detail and knowledge of scientific writing conventions
• Ability to multi-task and shift priorities rapidly to meet tight deadlines
• Excellent oral and written communication skills including outstanding experimental documentation
• Continual learner who works independently and possesses a can-do attitude
• Proficient in Microsoft Office suite and analysis-specific applications (e.g., Prism, GeneData, SLD).
• 
  
• Loxo Oncology, Inc. (Loxo) currently anticipates that the base salary for the Associate Scientist level position could range from between $59,000 to $86,577 and the Senior Associate Scientist position could range from between $67,850 to $99,563 and will depend, in part, on the successful candidate’s qualifications for the role, including education and experience. This position will also be eligible for a company bonus(depending, in part, on company and individual performance).  In addition, Loxo provides a comprehensive benefit program to eligible employees, including vacation, medical, dental and vision benefits; participation in a 401(k) plan; life and accidental death and disability coverage; parental leave benefits and employee discounts for certain items.  The compensation described above is subject to change and could be higher or lower than the range described above. Further, Loxo reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion.

Required Qualifications and Background

• B.S. or M.S. in chemistry or biochemistry with >2 years’ experience in industry or academia.
• To be considered for the Senior Associate Scientist position the candidate must have drug discovery experience gained in a biotechnology or pharmaceutical company.

Roles and Responsibilities of the Position

• Execute enzyme activity and binding assays in multiple formats, including fluorescence intensity, fluorescence polarization, TR-FRET, AlphaScreen, and Luminescence.
• Screen small molecule inhibitors in plate-based assays formats to drive internal structure-based drug design.
• Perform comprehensive data analysis and communicate experimental findings to the project team members.
• Operate, implement, and troubleshoot laboratory automation.
•  

Additional Skills/Preferences

• Familiarity with enzyme kinetics and enzyme assay methods.
• Experience with laboratory instrumentation and automation for medium to high-throughput screening
• Excellent oral and written communication skills including experimental documentation
• Works well with team members daily across functional areas
• Ability to multi-task and shift priorities rapidly to meet tight deadlines
• Highly organized with exceptional attention to detail
• Good and thoughtful listener
• Enthusiastic, self-motivated and a continuous learner
• Proficient in Microsoft Office suite and applications

• Loxo Oncology, Inc. (Loxo) currently anticipates that the base salary for the Associate Scientist position level could range from between $59,000 to $86,577 and that the base salary for the Senior Associate Scientist position level could range from between $67,850 to $99,563 and will depend, in part, on the successful candidate’s qualifications for the role, including education and experience. This position also will be eligible for a company bonus(depending, in part, on company and individual performance).  In addition, Loxo provides a comprehensive benefit program to eligible employees, including vacation, medical, dental and vision benefits; participation in a 401(k) plan; life and accidental death and disability coverage; parental leave benefits and employee discounts for certain items.  The compensation described above is subject to change and could be higher or lower than the range described above. Further, Loxo reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion.

Roles and Responsibilities of the Position

• The successful candidate will have a flexible, learning mindset to design and deliver scientific databases, create workflows to process and analyze high-dimensional data. This will include development of self-service analytics tools to enable and facilitate the real-time analysis of scientific data within our research community. This position will lead local and off-shore engineering teams to deliver informatics solutions focused on data accessibility, quality, and reproducibility.

Required Qualifications and Background

• Bachelor’s/Master’s/PhD in computer science, bioinformatics, or equivalent experience
• 2+ years of software development experience, including experience in computer science, bioinformatics or other applied science
• Documented track record delivering and deploying large-scale informatics production solutions in the cloud using AWS/Azure and Docker
• Experience implementing bioinformatics pipelines using scalable cloud solutions. Familiarity with Nextflow, Snakemake, or WDL/Cromwell a plus.
• Understanding of NGS technology, and downstream -omics data analysis (RNAseq, ATACseq, ChIPseq, etc.).
• Familiarity with designing, maintaining and implementing relational databases. Experience with NoSQL databases a plus
• Proficiency in working within a Linux/Unix environment
• High-level understanding of full-stack web development including implementing RESTful web services with Javascript and related languages
• Strong scripting abilities using Python, Perl, Go, Javascript or any other related programming language

Available Locations for this role

• South San Francisco, CA
• New York City, NY
• US Based- Remote




Loxo Oncology, Inc. (Loxo) currently anticipates that the base salary for this position could range from between $89,750 to $131672 for a senior scientist and $103,200 to $151,423 for a Principal Scientist and will depend, in part, on the successful candidate’s qualifications for the role, including education and experience. This position also will be eligible for a company bonus(depending, in part, on company and individual performance).  In addition, Loxo provides a comprehensive benefit program to eligible employees, including vacation, medical, dental and vision benefits; participation in a 401(k) plan; life and accidental death and disability coverage; parental leave benefits and employee discounts for certain items.  The compensation described above is subject to change and could be higher or lower than the range described above. Further, Loxo reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion.

Roles and Responsibilities of the Position:

• Utilize software tools to track inventory of oncology research and clinical biomarker samples
• Maintain accurate and concise inventory of research and clinical/preclinical oncology biomarker samples across drug programs and third-party labs
• Support clinical development teams to design biospecimen handling logistics with preferred vendors
• Maintain regular metrics of biospecimen activities for studies
• Track and resolve discrepancies with study team, sites, or CRO vendors within specified time frames
• Assist in developing biospecimen collection plans with vendors by aligning with the clinical study protocol for sample collection requirements.
• Use monitoring tools to proactively identify trends and provide feedback to internal departments
• Oversee shipments of biomarker samples from sample repositories to third party labs for testing.

Required Qualifications and Background:

• Bachelors’ degree in Life Sciences, health related field or equivalent experience
• Minimum of 4+ years sample management experience in pharmaceuticals, laboratory, or biorepository setting
• Oncology experience required across all phases of clinical trials
• Good working knowledge of ICH, FDA, and GCP regulations and guidelines.
• Excellent verbal/written and interpersonal skills required for working successfully in a cross-functional team environment.
• Able to communicate and collaborate effectively with cross-functional teams in face-to-face conversation, by telephone, and by email.
• Excellent organizational skills with high attention to detail is required
• Strong computer skills (spreadsheets, word processing, etc.) is required
• Experience using sample management database is preferred
• Ability to manage, prioritize, and routinely report progress on multiple projects and tasks

Available locations for this role:

• Stamford, CT
• South San Francisco, CA
• US Based-Remote

Roles and Responsibilities of the Position

• Provide operational input on development, management and maintenance of study deliverables [i.e. timelines, study plans, documents, etc.] through collaboration with internal and external stakeholders.
• Contribute to deliverables within study, drive to solutions across a multi-functional study team.
• Anticipate and resolve key technical operational problems with multi-functional study team; evaluate and determine issues that require escalation.
• Use performance metrics and quality indicators to assist with driving study execution.
• Manage the monitoring visit report review process in order to maintain oversight of clinical monitoring quality and adherence to protocol and established processes and plans.
• Support Health Authority inspections and CQA audits as required. 
• Ensure completeness & accuracy of the required data in study management tools including clinical trial management systems, patient enrollment forecasting, etc.
• Provide proactive identification of potential risks and development/implementation of actions to avoid or mitigate.
• Develop and maintain collaborative relationships with internal and external partners/stakeholders including both vendors and investigational sites.
• Collaborate with vendors and other study team members regarding study specific issues and follow through to resolution.
• Assist in the creation and review of study documents, including but not limited to the Protocol, Informed Consent Form (ICF) and other patient facing materials and assist in updating these study documents as needed.  The CRA may have opportunities to lead creation/updates/review of study documents, as agreed upon with assigned Clinical Trial Manager or Clinical Operations leadership.
• Participate in vendor specification development and management/oversight.  Vendor oversight activities may include responsibility for specific tasks associated with oversight (ie, review of monitoring visit reports generated by CRO) or may opportunities to lead the overall management of a specific vendor (ie, travel vendor), as agreed upon with assigned Clinical Trial Manager or Clinical Operations leadership.
• Management of TMF set-up, ongoing quality review, and final reconciliation.
• In conjunction with Drug Supply Management, manage shipment and reconciliation of Investigational Product (IP) at study and site level as needed.
• Liaise as needed with CRO and investigative sites to ensure clinical trial data is captured and resolved as required.
• Contribute to data review/cleaning of clinical data as needed and as defined by study plans.
• Actively contribute during study meetings including presenting as a subject matter expert as well as generating and distributing study team agendas and meeting minutes.
• Contribute to development / coordination of study training and study training materials for study team, investigational sites, and vendors. 
• Contribute to oversight of the required country regulatory (e.g. CTA, MoH) and country/site IRB/IEC submissions/approvals/notifications.
• Assist with the collection of various study documents such as country/site insurance, CSR appendices, etc.
• Assist with Investigator Meeting coordination and planning.
• In addition to all activities listed, Senior CRAs must be able to manage larger, more complex deliverables within a clinical trial with minimal oversight.

Required Qualifications and Background

• BA/BS Degree in a relevant discipline with 2-4 years’ experience in the clinical trial environment required (inclusive of site level or other relevant experience) for Clinical Research Associate level; direct sponsor and/or CRO experience or 5+ years relevant non-sponsor or CRO experience required for Senior CRA level.
• Knowledge of ICH/GCP and regulatory guidelines/directives.
• Demonstrates analytical approach and anticipation of problems.
• Identifies gaps and provides constructive feedback and solutions.
• Ability to multi-task effectively and prioritize assignments from multiple sources.
• Excellent organizational skills.
• Strong communication skills, both written and oral; proficiency in English.
• Strong knowledge of MS applications including (but not limited to) MS Project, Word, Excel, PowerPoint.
• Knowledge of study tools including electronic system skills such as CTMS/ EDC/ IRT/ eTMF.
• Knowledge of drug development process. Proactively shares information, ideas, input, and/or expertise with team members. Demonstrates concern for high quality outcomes.
• Responds flexibly to changing business demands and opportunities, proactively looking for ways to contribute.

Available locations for this role

• Stamford, CT
• South San Francisco, CA
• US Based-Remote


Loxo Oncology, Inc. (Loxo) currently anticipates that the base salary for the Clinical Research Associate position level could range from between $78,000 to $114,498 and that the base salary for the Senior Clinical Research Associate position level could range from between $89,750 to $131,672 and will depend, in part, on the successful candidate’s qualifications for the role, including education and experience. This position also will be eligible for a company bonus(depending, in part, on company and individual performance).  In addition, Loxo provides a comprehensive benefit program to eligible employees, including vacation, medical, dental and vision benefits; participation in a 401(k) plan; life and accidental death and disability coverage; parental leave benefits and employee discounts for certain items.  The compensation described above is subject to change and could be higher or lower than the range described above. Further, Loxo reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion.

Roles and Responsibilities of the Position

• Contribute to the execution of clinical trials, drive to solutions across a multi-functional study team.
• Anticipate and resolve complex and key technical, operational or business problems with multi-functional study team; evaluate and determine issues that require escalation.
• Use performance metrics and quality indicators to drive study execution.
• Support Health Authority inspections and CQA audits as required, including driving inspection/audit readiness through life of study. 
• Collaborate with study team and/or CRO to ensure completeness & accuracy of the required data in study management tools including clinical trial management systems, patient enrollment forecasting, etc.
• Proactively identify potential risks and lead the development/implementation of actions to avoid or mitigate; identify points for escalation.
• Collaborate with vendors and other study team members regarding study specific issues.
• Lead and/or collaborate in the creation and review of study documents, including but not limited to the Protocol, Informed Consent Form (ICF) and other patient facing materials, case report forms, and clinical study reports. Manage completion of these deliverables to ensure timelines are upheld. Ensure study documents are updated as needed throughout the trial.
• Plan site and country identification and selection in collaboration with internal partners.
• As appropriate per vendor/scope of work, manage and/or participate in vendor selection, specification development and management/oversight. 
• Ensure management of the TMF set-up, ongoing quality review, and final reconciliation.
• Liaise as needed with CRO and investigative sites to ensure clinical trial data is captured and resolved as required.
• Contribute to data review/cleaning of clinical data as needed and as defined by study plans.
• Manage the development/coordination of study training and study training materials for study team, investigational sites, and vendors. 
• Contribute to oversight of the required country regulatory (e.g. CTA, MoH) and country/site IRB/IEC submissions/approvals/notifications.
• Ensure the collection of various study documents such as country/site insurance, CSR appendices, etc. is completed as needed.

Required Qualifications and Background

• BA/BS degree in a relevant discipline with 5+ years’ experience in clinical drug development required at Clinical Trial Manager level.
• Oncology and/or Hematology experience preferred.
• Experience in managing global clinical trials preferred.
• Experience with managing clinical research budgets.
• Knowledge of ICH/GCP and regulatory guidelines/directives.
• Experience with managing a multi-functional team, including leadership skills and driving deliverables.
• Demonstrates analytical approach and anticipation of problems.
• Identifies gaps and provides constructive feedback and solutions.
• Follows issues to resolution and escalates as appropriate.
• Ability to multi-task effectively and prioritize assignments from multiple sources.
• Excellent organizational skills.
• Strong communication skills, both written and oral; proficiency in English.
• Strong knowledge of MS applications including (but not limited to) MS Project, Word, Excel, PowerPoint.
• Knowledge of study tools including electronic system skills such as CTMS/ EDC/ IRT/ eTMF.
• Knowledge of drug development process. Proactively shares information, ideas, input, and/or expertise with team members. Demonstrates concern for high quality outcomes.
• Responds flexibly to changing business demands and opportunities, proactively looking for ways to contribute.

Available locations for this role:

• Stamford, CT
• South San Francisco, CA
• US Based-Remote




Loxo Oncology, Inc. (Loxo) currently anticipates that the base salary for Manager position level could range from between $103,200 to $151,423 and will depend, in part, on the successful candidate’s qualifications for the role, including education and experience. This position also will be eligible for a company bonus(depending, in part, on company and individual performance).  In addition, Loxo provides a comprehensive benefit program to eligible employees, including vacation, medical, dental and vision benefits; participation in a 401(k) plan; life and accidental death and disability coverage; parental leave benefits and employee discounts for certain items.  The compensation described above is subject to change and could be higher or lower than the range described above. Further, Loxo reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion.

Roles and Responsibilities of the Position:

• Provide operational leadership on development, management and maintenance of study deliverables [i.e. timelines, study plans, documents, etc.] through collaboration with internal and external stakeholders.
• Lead and manage the execution of clinical trials, drive to solutions across a multi-functional study team.
• Anticipate and resolve complex and key technical, operational or business problems with multi-functional study team; evaluate and determine issues that require escalation.
• Use performance metrics and quality indicators to drive study execution.
• Support Health Authority inspections and CQA audits as required, including driving inspection/audit readiness through life of study. 
• Manage study team and/or CRO to ensure completeness & accuracy of the required data in study management tools including clinical trial management systems, patient enrollment forecasting, etc.
• Proactively identify potential risks and lead the development/implementation of actions to avoid or mitigate; identify points for escalation.
• Develop and maintain collaborative relationships with internal and external partners/stakeholders including both vendors and investigational sites.
• Collaborate with vendors and other study team members regarding study specific issues; drive team through issue resolution.
• Lead and/or collaborate in the creation and review of study documents, including but not limited to the Protocol, Informed Consent Form (ICF) and other patient facing materials, case report forms, and clinical study reports. Manage completion of these deliverables to ensure timelines are upheld. Ensure study documents are updated as needed throughout the trial.
• Partner with internal contracts management to ensure review, finalization, and escalation as needed of site contracts and budgets.
• Plan site and country identification and selection in collaboration with internal partners.
• As appropriate per vendor/scope of work, manage and/or participate in vendor selection, specification development and management/oversight. 
• Ensure management of the TMF set-up, ongoing quality review, and final reconciliation.
• Liaise as needed with CRO and investigative sites to ensure clinical trial data is captured and resolved as required.
• Contribute to data review/cleaning of clinical data as needed and as defined by study plans.
• Lead study meetings including presenting as a subject matter expert as needed, ensuring agenda and meeting minutes are generated and distributed as needed.
• Manage the development/coordination of study training and study training materials for study team, investigational sites, and vendors. 
• Contribute to oversight of the required country regulatory (e.g. CTA, MoH) and country/site IRB/IEC submissions/approvals/notifications.
• Ensure the collection of various study documents such as country/site insurance, CSR appendices, etc. is completed as needed.
• Manage Investigator Meeting coordination and planning.
• Lead and assist in training other Clinical Operations roles (e.g. CRAs). 
• In addition to all activities listed, Senior Clinical Trial Managers must be able to manage large, complex trials and/or manage multiple ongoing studies simultaneously with minimal oversight.

Required Qualifications and Background:

• BA/BS degree in a relevant discipline with 5+ years’ experience in clinical drug development required at Clinical Trial Manager level; 6+ years’ experience required for Senior Clinical Trial Manager level.
• Clinical Pharmacology/Healthy Volunteer experience preferred
• Experience in managing global clinical trials preferred.
• Experience with managing clinical research budgets.
• Knowledge of ICH/GCP and regulatory guidelines/directives.
• Experience with managing a multi-functional team, including leadership skills and driving deliverables.
• Demonstrates analytical approach and anticipation of problems.
• Identifies gaps and provides constructive feedback and solutions.
• Follows issues to resolution and escalates as appropriate.
• Ability to multi-task effectively and prioritize assignments from multiple sources.
• Excellent organizational skills.
• Strong communication skills, both written and oral; proficiency in English.
• Strong knowledge of MS applications including (but not limited to) MS Project, Word, Excel, PowerPoint.
• Knowledge of study tools including electronic system skills such as CTMS/ EDC/ IRT/ eTMF.
• Knowledge of drug development process. Proactively shares information, ideas, input, and/or expertise with team members. Demonstrates concern for high quality outcomes.
• Responds flexibly to changing business demands and opportunities, proactively looking for ways to contribute. 




Loxo Oncology, Inc. (Loxo) currently anticipates that the base salary for the Clinical Trial Manager could range from between $103,200 to $151,423 and that the base salary for the Senior Clinical Trial Manager could range from between $118,700 to $174,137 and will depend, in part, on the successful candidate’s qualifications for the role, including education and experience. This position also will be eligible for a company bonus(depending, in part, on company and individual performance).  In addition, Loxo provides a comprehensive benefit program to eligible employees, including vacation, medical, dental and vision benefits; participation in a 401(k) plan; life and accidental death and disability coverage; parental leave benefits and employee discounts for certain items.  The compensation described above is subject to change and could be higher or lower than the range described above. Further, Loxo reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion.

Roles and Responsibilities of the Position

• The successful candidate will work in a face-paced and highly collaborative environment to tackle important questions in oncology drug development. They will employ the latest genomics and statistical approaches to interrogate these questions. Success critically depends on an ability to effectively present complex analyses and results in a clear and concise manner to a diverse audience of scientists.

Required Qualifications and Background

• MS/PhD in Bioinformatics, Biostatistics, Computational Biology, or similar area of study. Alternatively, post-graduate training in high-dimensional data analyses, supported by scientific achievements (eg., publications, patents, etc), would also be considered equivalent.
• Relevant experience must be supported by scientific accomplishments such as publications, scientific presentations, patents, etc.
• Strong understanding of relevant concepts in cancer biology and molecular biology.
• Hands-on experience with data analysis involving high-throughput molecular assays such as DNA/RNA-Seq, ATAC/ChIP-Seq, single-cell technologies, etc.
• Understanding of current best-practices for high-throughput genomics/molecular data analyses and their underlying statistical principles.
• Experience using programming languages such as R, Python, or similar for statistical analysis.

Available Locations for this role

• South South Francisco, CA
• New York City, NY
• US Based- Remote




Loxo Oncology, Inc. (Loxo) currently anticipates that the base salary for this position could range from between $78,000 to $114,497 and will depend, in part, on the successful candidate’s qualifications for the role, including education and experience. This position also will be eligible for a company bonus(depending, in part, on company and individual performance).  In addition, Loxo provides a comprehensive benefit program to eligible employees, including vacation, medical, dental and vision benefits; participation in a 401(k) plan; life and accidental death and disability coverage; parental leave benefits and employee discounts for certain items.  The compensation described above is subject to change and could be higher or lower than the range described above. Further, Loxo reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion.

Roles and Responsibilities for this Position

• Plan, schedule, and monitor the execution of CMC development and manufacturing activities (in collaboration with CMC project leaders) for LO@LLY development programs.
• Partner with the Vice President, CMC to plan and prioritize CMC activities for all development programs.
• Works with process chemistry, pharmaceutics, analytical development, and clinical supply to develop and maintain integrated CMC project plans and timelines for all development programs. Ensures that plans incorporate cross-functional input from CMC regulatory affairs, quality, nonclinical and clinical.
• Prepare and track program budgets, timelines, and deliverables. Develop and maintain performance and cost metrics for external partners.
• Interface with Business Operations, CMC. Drive MSA and SOW execution.
• Collate and communicate the status of projects and activities at CMOs to LO@LLY management. Prepare program reports for internal stakeholders using established templates and processes.
• Set up a system to track budget vs. spend and develop models for new program forecasting.
• Provide project management support for functional areas. Organizes sub-team meetings and ad-hoc working groups as needed to address specific topics. 

Qualifications and Background Requirement

• BA/BS and a minimum of 12 years of experience working in a Biotech or Pharmaceutical FDA regulated industry or an equivalent combination of education, training and/or experience from which comparable knowledge, skills and abilities have been attained.
• Expert understanding of pharmaceutical development, CMC, manufacturing, packaging, and labeling.
• Ability to manage development timelines and budget to support programs.
• Eager to communicate and collaborate with team members across functions and organizations.
• Working knowledge of cGMPs (CFR/ICH) and applicable international regulations/guidelines.
• In-depth understanding of CMC development activities for marketing authorizations.
• Global experience with phase 1-4 clinical trials.
• Experience writing and presenting clearly on CMC topics.
• Ability to work in a virtual environment.


Loxo Oncology, Inc. (Loxo) currently anticipates that the base salary for this position could range from between $135,300 to $198,516 and will depend, in part, on the successful candidate’s qualifications for the role, including education and experience. This position will also be eligible for a company bonus (depending, in part, on company and individual performance).  In addition, Loxo provides a comprehensive benefit program to eligible employees, including vacation, medical, dental and vision benefits; participation in a 401(k) plan; life and accidental death and disability coverage; parental leave benefits and employee discounts for certain items.  The compensation described above is subject to change and could be higher or lower than the range described above. Further, Loxo reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion.

Available Locations for this Position

• US Based Remote
• Indianapolis, IN

Roles and Responsibilities for the Position

• Lead the policy and training implementation strategy of Lilly corporate and local policies.  This includes but is not limited to the areas of Ethics and Compliance, IT, Communications/Publications, Finance, Discovery/Clinical Development, and other functional areas across the company.   
• Oversee records retention program.
• Partner with Lilly corporate policy owners, Learning and Development team members, Lilly Policy Committees and functional area leaders to assess policies, perform gap assessments, partner with the business to draft and revise policies where applicable to the oncology organization, implement applicable policies and assign training.
• Develop an enterprise-wide training program that streamlines training across LO@LLY functional areas (Ethics & Compliance, HR, QA, etc).  This includes but is not limited to developing “right sized” curricula for LO@LLY and Lilly Oncology roles, while ensuring all corporate and local requirements are being met, appropriate training is assigned to personnel and business risks are mitigated.
• Apply Learning best practices to LO@LLY’s required trainings, ensuring all trainings are as user-friendly as possible.
• Partner with SMEs to create and update trainings as appropriate, ensuring relevance to and alignment with LO@LLY culture
• Proactively communicate company-wide training expectations across the organization

Required Qualifications and Background

• Bachelor’s degree required with 7-10 years’ experience working in the Biotech/Pharmaceutical industry.
• Proven experience in training and policy strategy for complex/matrixed organizations and processes.
• Experience working in Learning Management Systems (LMS) (e.g. SuccessFactors preferred)
• Demonstrated ability to work well with senior leaders and accomplished professionals within and across functions/companies.
• Ability to collaborate with various teams across the company at all levels of the organization and drive results while working with matrixed organization and SMEs throughout LO@LLY, Lilly Oncology and Corporate.
• Good project management skills and ability to drive execution of projects within projected timelines.
• Willing collaborator. Solution-oriented.
• Strong written and oral communication skills.
• Ability to multi-task and shift priorities rapidly to meet tight deadlines.
• Requires a flexible work schedule to accommodate program priorities and international activities as needed
• Excellent written and verbal communicator.
• Strategic thinker, open-minded and flexible to adopting new ideas.
• Motivated, committed and self-managed.
• Detail oriented and well organized.
• Good and thoughtful listener.
• Enthusiastic, self-motivated and keen to improve processes and overcome inefficiencies.
• Proficient in Microsoft Office suite and applications.
• Works with a sense of urgency
• Prior pharma/biotech oncology discovery & clinical development Training experience preferred, but not required


Loxo Oncology, Inc. (Loxo) currently anticipates that the base salary for the Director could range from between $135,300 to $198,516 and will depend, in part, on the successful candidate’s qualifications for the role, including education and experience. This position will also be eligible for a company bonus(depending, in part, on company and individual performance).  In addition, Loxo provides a comprehensive benefit program to eligible employees, including vacation, medical, dental and vision benefits; participation in a 401(k) plan; life and accidental death and disability coverage; parental leave benefits and employee discounts for certain items.  The compensation described above is subject to change and could be higher or lower than the range described above. Further, Loxo reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion. 

Available Locations for this Role

• South San Francisco, CA
• Stamford, CT
• Indianapolis, IN
• Boulder, CO
• US Based-Remote

Roles and Responsibilities of the Position

• Work in a team environment to drive and manage CHO cell line development and upstream bioreactor process development, characterization and manufacturing activities primarily at third-party partners for assigned projects.
• Provide technical and scientific direction to third-party partners.
• Partner with colleagues in discovery, downstream process development and analytical to develop integrated clinical process and manufacturing solutions that achieve quality by design targets with robust control strategies.
• Oversee the preparation of technical reports, data summaries and CMC related documents required for various regulatory submissions.
• Write and review sections in regulatory submission documents (e.g., IND, IMPD, BLA).
• Key member of the interdisciplinary CMC project teams. 

Qualifications and Background Required

• BS degree required. Prefer candidates with a Master’s and/or PhD in chemical engineering, bioengineering, biological engineering or related field.
• Minimum of ten (10) years of experience working in a Biotech or Pharmaceutical FDA regulated industry or an equivalent combination of education, training and/or experience from which comparable knowledge, skills and abilities have been attained.
• Technical background and hands-on experience with mammalian cell culture and fed-batch processes to produce recombinant proteins.
• Scientific understanding and working knowledge of CHO cell biology, metabolism, cell culture media and engineering principles for large scale recombinant protein production systems. Understanding of cell culture bioreactors including microbioreactors, bench-scale and pilot scale, and scale up principles.
• Working knowledge of statistical methods (design of experiments, multivariate data analysis) and tools.
• Direct experience with managing third-party partners for process development and manufacturing in support of CMC activities.
• Knowledgeable in chemical and physical characterization of biologic proteins and antibodies.
• Knowledge of regulatory environment (ICH/FDA/EMA regulations) and experience with organizing and writing regulatory submissions.
• Experience writing and presenting clearly on CMC topics.
• Demonstrable ability to work proactively, independently, and tenaciously.
Loxo Oncology, Inc. (Loxo) currently anticipates that the base salary for this position could range from between $135,300 to $198,516 and will depend, in part, on the successful candidate’s qualifications for the role, including education and experience. This position will also be eligible for a company bonus (depending, in part, on company and individual performance).  In addition, Loxo provides a comprehensive benefit program to eligible employees, including vacation, medical, dental and vision benefits; participation in a 401(k) plan; life and accidental death and disability coverage; parental leave benefits and employee discounts for certain items.  The compensation described above is subject to change and could be higher or lower than the range described above. Further, Loxo reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion.

Available Locations for the Role

• Boulder/Louisville, Colorado
• Remote (US Based)

Role and Responsibilities of the Position

• Perform triage of incoming Serious Adverse Event (SAE) reports and consider assessments of seriousness, listedness, and causality; coordinate triage review with medical monitor.   
• Review case narratives, including identifying relevant information from source documents and write/review queries when additional information needed 
• Review data entry of SAEs in safety database including MedDRA coding
• Coordinate medical monitor case review
• Assist with the management of case processing deadlines
• Assist in reconciliation between the safety and clinical databases for serious adverse events.
• Compile safety information for aggregate safety reports and other safety related reports.
• Assist with ongoing safety surveillance
• Assist with compilation and updating of safety related spreadsheets including metrics and SUSAR submissions
• Review and update existing standard operating procedures (SOPs) and assist with creation of new SOPs for safety department as indicated  
• May oversee work performed by a safety Contract Research Organization (CRO)

Required Qualifications and Background

• RN, BSN or pharmacy degree with at least 3-5 years of industry experience in Clinical Trial Safety; industry experience from CRO or pharmaceutical/biotech setting will be considered.
• Previous experience in Health care is strongly preferred
• Hands on experience with SAE case processing including narrative and analysis of similar event (AOSE) writing, and safety report generation.
• Working knowledge of MedDRA and WHODrug and FDA safety regulations, ICH guidelines, and global safety reg
• Hands on experience with global safety database(s); experience with Argus strongly preferred.
• Demonstrated ability to work well with other accomplished professionals within and across functions/teams.
• Willing collaborator with strong written and oral communication skills.
• Ability to multi-task and shift priorities rapidly to meet tight deadlines.
• Detail oriented and well organized.
• Self-motivated and keen to improve processes and overcome inefficiencies.
• Proficient in Microsoft Office suite and applications. 

Roles and Responsibilities

• Serve as a subject matter expert for Data Management Systems and Processes with expertise in the use of EDC platforms and suite of products including EDC, Local Lab Module, Studio/Designer, Data Extract and Reporting, among others. 
• Provide oversight, technical support, and guidance to the study teams in the efficient use of the EDC product suite in the study planning, execution, and close out activities of clinical studies.
• Expertise in executing EDC Administration Tasks – including CRO Coder Administration, assisting study data managers in completing the study execution activities, site and user administration, etc.
• Expertise in the development, support, and optimal use of the Loxo CRF Library (Veeva CDMS, et al) and other data environments.
• Manage all quality deliverables including documentation to ensure the validated state of the product in partnership with EDC vendor partners, QA, and IT for software releases and bug fixes.
• Provide Clinical Programming expertise and support for critical and time-sensitive study milestones including, but not limited to, interim analysis, and database lock activities.
• Ability to support business initiatives along with being an advocate for business stakeholders to various system owners
• Proactively identifies potential technical and operational issues/risks and recommends/ implements solutions.
• Provide technical expertise and programming support for medical coding activities
• Engage in the governance and management of the Loxo CRF Library Standards; maintain and support Library documentation. 
• Work closely with the study teams to develop specifications, support adhoc reporting needs, and facilitate user acceptance testing in partnership with internal and external stakeholders, as needed.
• Partner with internal and external stakeholders to ensure timely delivery of data management programming, EDC database, external data, data management programming of reports and listings including the use of J-Review or other visualization tools.
• Contribute to the quality of the data management clinical database programming deliverables including edit checks programming, complex reports, and listings; patient profiles, exception listings, dose modification reports, and other ad hoc reports as required by the study teams.
• Perform QC, develop validation scripts for user acceptance, execute programs and reports as needed in preparation of user acceptance activities and in support of critical study milestones as needed.
• Develop and maintain mapping and program specifications for standard reports, listings, and visualizations.
• Establish and implement programming standards and comply with regulatory requirements among project team members and across all studies.
• Participate in the development of and ensure compliance to Standard Operating Procedures (SOPs), policies, and guidelines.
• Perform all other tasks and activities as requested

Require Qualifications and Preferred Background

• Bachelor’s degree in life sciences, math, computer science or related field required.  Master’s degree in life sciences, math, computer science or related field preferred.
• Minimum of 10 years EDC trial build and database programming experience and data validation programming in the device/pharmaceutical/CRO industry
• Minimum 3 years oncology experience 
• Must have excellent verbal, written and communication skills.
• Expertise in Clinical Programming, methods, and techniques
• Knowledge of industry standard clinical technologies including CTMS, EDC (Veeva CDMS preferred, Rave, InForm), Clinical Data Repositories, etc.
• Knowledge of CDISC standards/standard terminology
• Knowledge and understanding of relational databases
• Experience in early phase, first-in-human clinical studies
• Sponsor experience preferred R
• Recent submission experience preferred (FDA, EMA, PMDA, etc)

Roles and Responsibilities of the Position

• Actively coordinate with Loxo Biologics Discovery SSF team members to understand the needs (both routine and seasonal) for lab supplies and consumables, and order, receive, store, and maintain them on a regular basis.
• Proactively maintain appropriate lab supplies and consumables and maintain appropriate inventory by monitoring the consumption of the consumables and supplies. Support in forecasting and capacity planning to ensure uninterrupted supplies.  
• Maintain status of receipt of the consumable and supplies and approve invoices tied to the orders in a timely manner.
• Implement and maintain equipment certification and calibration - maintain a list of equipment and keep track of calibration needs and assist in routine preventative maintenance of the equipment.
• Manage the equipment temperature and CO2 monitoring needed for the relevant equipment in the lab.
• Actively coordinate with Loxo SSF logistics team to ship and receive materials for the SSF Loxo Biologics group.
• Provide support to the team in delivery and installation of the large equipment as needed.
• Organize documentation associated with the key consumables and supplies, e.g., instruction manuals for laboratory instrumentation, COA, MSDS etc.
• Provide support to other laboratory administrative duties as needed.

Required Qualifications and Preferred Background

• A minimum of 4 years of professional experience in the Biotech and Pharmaceutical industry and 2 years of direct lab management experience is required.
• Bachelor’s degree in science related discipline is highly preferred.
• Previous experience in lab setup, lab management, procurement, and inventory management are preferred.
• Demonstrates good verbal, written communication, and interpersonal skills
• Demonstrates consistent delivery of tasks with moderate supervision
• Highly motivated, organized, and detail oriented
• Anticipates gaps and applies proactive and practical approach to problem solving
• Open to new ideas and proactively set new processes to support the growth of the lab

Roles and Responsibilities of the Position

• Manage automation processes to support a variety of applications across the Bioassay Screening team, including application development, improvement, and optimization.
• Interact and collaborate with Small Molecule Discovery and Bioassay scientists to design, establish, and maintain integrated biological methods and a lab automation infrastructure.
• Develop, optimize, and validate custom automation protocols for various molecular and cell-based assays.
• Ensure consistent and high-quality data outputs from a variety of high-throughput and high-content platforms.
• Work with cross-functional personnel to develop and implement novel platforms and applications.
• Provide automation expertise for practical implementation of various applications across the entire Loxo organization.
• Train and support scientists on automation platforms and established SOPs, including hardware and software.
• Work with the entire Bioassay team to ensure all instrumentation is properly maintained and calibrated.
• Maintain proper documentation and archiving of data and analyses.
• Communicate results via written and oral presentations as needed.
• Discuss laboratory operational processes with technical as well as non-technical personnel.
• Maintain good interactions with third parties/vendors on new developments and products.

Required Qualifications and Background

• BS/MS in biological sciences, computer science, engineering, or other relevant field with 2+ years of laboratory automation experience.
• Extensive knowledge and experience designing and supporting laboratory automation and liquid handling.
• Experience with high-content, high-throughput laboratory workflows with emphasis on quality and efficiency.
• Experience converting manual protocols into automated processes, process optimization, and workflow efficiencies on automated equipment.
• High agility to learn new technologies, with an affinity for automation and high-end equipment.
• Demonstrated experience in working collaboratively across various disciplines to meet project goals and timelines.
• Flexibility to adjust priorities over time to meet organizational and scientific goals.
• Ability to work independently and as an integral part of a larger collaborative team.
• Demonstrated ability to succeed in a fast-paced environment, working on multiple projects with constantly changing priorities and deadlines
• Outstanding interpersonal, written, and verbal communication skills.

Additional Preferred Qualifications

• Experience with ECHO acoustic dispensers, TECAN Fluent liquid handling, or Cellario scheduling software is highly preferred.


Loxo Oncology, Inc. (Loxo) currently anticipates that the base salary for the Specialist position level could range from between $67,850 to $99,563 will depend, in part, on the successful candidate’s qualifications for the role, including education and experience. This position will also be eligible for a company bonus (depending, in part, on company and individual performance).  In addition, Loxo provides a comprehensive benefit program to eligible employees, including vacation, medical, dental and vision benefits; participation in a 401(k) plan; life and accidental death and disability coverage; parental leave benefits and employee discounts for certain items.  The compensation described above is subject to change and could be higher or lower than the range described above. Further, Loxo reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion.

Roles and Responsibilities of the Position

• Negotiates and executes agreements and budgets including but not limited to: master agreements, clinical trial agreements, general services agreements and amendments.
• Independently collaborates with clinical trial teams and other internal stakeholders, study start-up groups, investigational sites, and vendors to verify and develop budget, negotiate cost savings and ensure delivery of fully executed contracts in support of timely study start-up to meet departmental and organizational goal to meet departmental and organizational goals.
• Evaluates potential investigator sites from a financial and historical study start-up time perspective for critical site feasibility and selection to provide input for investigator selection decisions.
• Formulate request for proposals (RFP) for clinical services including bidding process and scope of work (SOW).
• Maintains proactive relationship with finance to ensure that all financial requirements are satisfied.  
• Liaison between clinical service groups (SMO, CRO), legal and clinical trial teams for outsourced trials.
• Provides a high level of negotiation expertise to resolve complex and “deal breaker” issues with external parties.
• Meet regularly with Legal to review agreements and business decision issues.
• Aids in developing contracts concepts and techniques and solves complex contractual problems that require ingenuity, innovation, and creativity.
• Independently collaborates cross functionally with Legal, Regulatory, Compliance, and Finance to negotiate contract wording changes.

Required Qualifications and Background

• BS degree in business administration, finance, science or related field or equivalent on the job experience may be considered; advanced degree a plus.
• Minimum 5-7 years of experience in pharmaceutical services with 5 years of hands-on, vendor side clinical contract management; full life cycle management of vendor side clinical contracts including, but not limited to: requests for RFPs, budgeting, benchmarking, contract negotiations and management, change orders, etc.
• High degree of organizational, analytical, and team management skills.
• Ability to handle complex budgets.
• Computer literacy with document and spreadsheet applications.
• Ability to work on complex, multi-faceted projects.
• Proven negotiation skills and vast knowledge of clinical trial agreements. 
• Demonstrated ability to work well with other accomplished professionals within and across functions/teams; Strong collaborator.
• Strong communication skills both written and oral.
• Ability to multi-task and shift priorities rapidly to meet tight deadlines.
• Professional demeanor.
• Detail oriented and well organized.
• Good and thoughtful listener.
• Enthusiastic, self-motivated and keen to improve processes and overcome any inefficiencies.
• Proficient in Microsoft Office suite and applications. 

Available locations for this role

• Remote
• South San Francisco, CA
• Stamford, CT


Loxo Oncology, Inc. (Loxo) currently anticipates that the base salary for the Manager position level could range from between $103,200 to $151,423 and will depend, in part, on the successful candidate’s qualifications for the role, including education and experience. This position also will be eligible for a company bonus(depending, in part, on company and individual performance).  In addition, Loxo provides a comprehensive benefit program to eligible employees, including vacation, medical, dental and vision benefits; participation in a 401(k) plan; life and accidental death and disability coverage; parental leave benefits and employee discounts for certain items.  The compensation described above is subject to change and could be higher or lower than the range described above. Further, Loxo reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion.

Roles and Responsibilities of the Position

• Manage the development and qualification/validation of analytical methods to support starting material, intermediate, drug substance and drug product testing at CDMOs
• Work collaboratively with process chemistry, pharmaceutics, QA, medicinal chemistry, CMC regulatory, and clinical development to support the delivery and release of test articles for different phases of animal and human studies
• Author and review technical documents, analytical development reports, and CMC sections for IND, IMPD and global marketing applications
• Manage multiple projects, set priorities, and work in a fast-paced environment
• Collaborate with CMC and regulatory colleagues to establish and justify specifications for drug substances, starting materials, intermediates and drug products
• Review and approval of analytical results, protocols and reports
• Monitor and evaluate results of drug product and drug substance stability studies
• Collaborate with QA, CMC team and CMOs towards timely generation and approval of documents
• Other duties as assigned

Required Qualifications and Background

• BS in analytical chemistry or related discipline with 9+ years of experience, MS with 6+ years experience, or Ph.D. with 4+ years experience in the pharmaceutical industry
• Requires a strong background in analytical method development, applying analytical techniques to solve challenging problems, and experience in IND-enabling and clinical stability study design
• Demonstrated proficiency in hands-on analytical work, vendor management, reviewing and organizing analytical data and solving analytical challenges at third party pharmaceutical manufacturers
• Experience authoring and reviewing technical documents including, but not limited to, development reports, analytical test methods, specifications, and evaluation of stability data
• Experience in drafting or reviewing CMC sections of INDs and IMPDs
• Experience in responding to inquiries from regulatory agency review
• In-depth knowledge of USP, regulatory, ICH and cGMP requirements
• Experience in late stage drug development
• Demonstrated ability to work well with other accomplished professionals within and across functions/teams.
• Strong written and oral communication skills
• Ability to multi-task and shift priorities rapidly to meet tight deadlines
• Self-motivated, and keen to improve processes and overcome inefficiencies


Loxo Oncology, Inc. (Loxo) currently anticipates that the base salary for this position could range from between $103,200 to $151,423 and will depend, in part, on the successful candidate’s qualifications for the role, including education and experience. This position will also be eligible for a company bonus(depending, in part, on company and individual performance).  In addition, Loxo provides a comprehensive benefit program to eligible employees, including vacation, medical, dental and vision benefits; participation in a 401(k) plan; life and accidental death and disability coverage; parental leave benefits and employee discounts for certain items.  The compensation described above is subject to change and could be higher or lower than the range described above. Further, Loxo reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion.

Roles and Responsibilities of the Position

• Point person for IT QA related items and act as IT QA representative internally and externally.
• Support the review of data integrity and regulatory assessments to ensure compliance with applicable regulatory requirements, internal and external standards (e.g. Part 11, GAMP, etc.).
• Perform the review and approval of IT system related change controls to ensure completeness and compliance with internal and external requirements.
• In addition to change controls, provide guidance on all IT related Quality system elements such deviations, CAPAs and SOPs.
• Author and review policies, standard operating procedures and work instructions related to IT activities and QA roles and responsibilities.
• Perform the review and approval of IT system SDLC documentation that includes, but is not limited to validation plans, reports, deviations, trace matrices, and executed UAT documentation.
• Work cross functionally with business areas to support IT system implementation and upgrades

Required Qualifications and Background

• BA/BS in science or engineering
• A minimum of 7-10 years of experience working in the Biotech or Pharmaceutical regulated industry in IT QA
• Veeva Vault experience strongly preferred (QualityDocs, eTMF, RIM)
• Current on regulatory and industry requirements and expectations (e.g. data integrity, GAMP, etc).
• Experience in executing, reviewing and approving Quality system elements (e.g.deviations, change controls, CAPAs, etc.)
• Self-starter and ability to make decisions with minimal oversight.
• Strong attention to detail and accuracy of work.
• Ability to multitask and work in a fast-paced environment to meet tight deadlines.
• Strong problem-solving skills and ability to lead process improvements
• Strong leadership skills and the ability to lead cross functional meetings
• Strong Quality and business knowledge to determine when to escalate issues when necessary
• Ability to work in a matrixed environment.
• Demonstrated ability to work well with other accomplished professionals at all levels of the organization.
• Strong internal and external collaborator.
• Strong communication skills both written and oral.
• Proficient in Microsoft Office suite and applications




Loxo Oncology, Inc. (Loxo) currently anticipates that the base salary for the Manager position level could range from between $103,200 to $151,423 and will depend, in part, on the successful candidate’s qualifications for the role, including education and experience. This position also will be eligible for a company bonus(depending, in part, on company and individual performance).  In addition, Loxo provides a comprehensive benefit program to eligible employees, including vacation, medical, dental and vision benefits; participation in a 401(k) plan; life and accidental death and disability coverage; parental leave benefits and employee discounts for certain items.  The compensation described above is subject to change and could be higher or lower than the range described above. Further, Loxo reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion.

Roles and Responsibilities of the Position:

• Operations/lab management:
• Lead and direct the operational activities of programs/research
• Coordinate with the Large Molecule Biology team members to understand the needs (both routine and seasonal) for lab supplies/consumables, and order, receive, store, and maintain them on a regular basis.
• Actively coordinate with Loxo NYC logistics team to ship and receive materials for the Large Molecule Biology group. Organize documentation associated with shipments.
• Work closely with other NYC based laboratory/sample managers for equipment maintenance and acquisition
• Provide support to other laboratory administrative duties as needed.
• Scientific strategy and execution:
• Provide support to Loxo Large Molecule Biology team in meeting the emerging needs of all programs and projects
• Assisting with slide deck assembly
• Providing scientific guidance and input to key projects
• Participating in key experiments (design and execution as well as design and delegation)
• Work directly with junior team members to coach and guide in experimental planning, execution, and analysis.
• Work closely with project management group as needed
• Support IND submissions and preclinical data package generation
• Assist organizing/leading lab meetings
• External partnerships and management:
• Helping with (existing/new) strategic collaborations (academic and/or industry partnerships) and CROs (identify and oversee as needed)
• Organize and lead meetings with external collaborator 

Required Qualifications and Preferred Background:

• 5+ years of Biotech/Pharmaceutical industry experience in working in the scientific field and an advanced degree in relevant scientific fields (e.g., biology) or 10+ years’ experience and a BS/MS degree.
• Experience in working with diverse set of scientific environments and able to execute requests with moderate supervision
• Previous experience of direct lab management, procurement and inventory management are highly preferred.
• Clearly understand the distinction between high-level scope and day-today operations
• Comfortable in collaborating with the vendors
• Good verbal, written communication, and interpersonal skills
• Excellent organizational skills, efficient, with strong attention to detail
• Demonstrates consistent delivery of tasks with moderate supervision
• Ability to anticipate problems and proactively propose solutions
• Highly motivated, organized and detail oriented
• Open to new ideas and proactively set new processes to support the growth of the lab
• Proficient in MS Office suite

Roles and Responsibilities of the Position:

• Liaise across departments to proactively identify opportunities to streamline and strengthen GCP processes
• Serves as GCP SME in writing and revising SOPs
• Reviews and approves Quality Events and associated Corrective and Preventative Actions within a regulated Quality Management System
• Represents GCP expertise and acts as the QA point person on cross-functional clinical study teams
• Keeps current with global health authority laws and regulations; identifies gaps and implements process improvements resulting from new/revised regulations or guidance
• Reviews study team and regulatory documentation as requested (e.g., Data Management, Operations, Safety, Regulatory, etc.)
• Liaises audit requirements between clinical study teams and auditing group and follows up on audits with the auditee
• Utilizes the Loxo Quality Systems to manage Quality system elements
• Drives inspection readiness activities for project teams
• Supports external Health Authority inspections

Required Qualifications and Background:

• Bachelor’s degree with 5- 7 years’ experience working in either a clinical compliance or clinical quality group
• Must be a hands-on leader who can provide guidance and execute daily tasks
• Demonstrated Quality Management System experience (GCP specific QMS experience preferred)
• Demonstrated Issue Management and CAPA experience in a clinical environment
• Strong knowledge of global clinical trial regulations and guidelines
• Proficient in risk management principles
• Experience with FDA or other Regulatory Inspections of Investigator sites, Sponsors or CROs
• Self-motivated with the ability to work effectively in a dynamic environment with initiative and great organization skills
• Strong leadership with demonstrated ability to interface with senior leaders and different levels of the organization
• Ability to deal with ambiguity, creative and pragmatic approach to problem solving
• Ability to be adaptable and effectively manage multiple priorities with a sense of urgency
• Strong track record of project management, stakeholder management, collaboration skills and negotiation of complex situations
• Attention to detail and accuracy of work
• Demonstrated ability to work well with other accomplished professionals within and across functions/teams. Willing collaborator.
• Excellent interpersonal and communication skills (both written and oral)
• Works with a sense of urgency and has the ability to multi-task and shift priorities rapidly to meet tight deadlines
• Professional demeanor and appearance and a team player
• Detail oriented with analytical and problem-solving skills and well organized
• Good and thoughtful listener
• Critical thinker and solution oriented
• Enthusiastic, self-motivated and self-starter

Roles and Responsibilities of the Position

• Represent CDM from a strategic planning and execution capacity in development team meetings.
• Oversees service providers to perform core data management functions including CRF design, edit check development, user acceptance testing, data cleaning, reviewing listings, and database locking procedures.
• Evaluates and makes recommendations related to inter- and intra-departmental processes in order to identify and implement efficiencies and quality improvement measures Leads and manages DM tasks outsourced to external vendors and ensures that milestones, deliverables, quality and timelines are met within budget and in accordance with regulatory requirements.
•  Executes according to the DM outsourcing and related strategies and processes, developing positive partnerships with CROs and ensuring a high standard of deliverables is maintained.
• Works closely with Data Management Clinpharm Leadership (DMCP) for streamlining DM related aspects.
• Supports collaboration, communication, coordination and prioritization within the department working in conjunction with line Manager and DM CP Leadership.
• Contribute to the evaluation of RFPs, subsequent bid defenses and the eventual selection of vendor partners.
• Proactively identifies potential Study and delivery issues/risks and recommends/ implements solutions.
• Serves as the DM focal point on assigned studies for all internal and external teams and preserves a fluent workflow with the cross-functional departments and stipulated procedures and processes.
•  Develop and ensure that deep knowledge of internal, external and regulatory requirements/expectations are understood, well communicated and applied to data deliverables.
• Effectively apply knowledge of applicable internal, external, and regulatory requirements/expectations (MHRA, FDA, ICH, GCP, PhRMA, Privacy, etc.) to data collection, validation and CDM documents.
• Support CDM department-level improvement initiatives.
• Monitors the progress of all data management activities on all studies to ensure project timelines are met.
• Performs all other tasks and activities as assigned/requested.
• Represents Data Management and facilitates project related integration with other groups, notably Clinical, Operations Stats Programming, Statistics, QA and Regulatory.
• Collaborate with other Clinical Data Management leads upon need.
• Authors, Reviews or Approves Data Management Plans for completeness and accuracy as required by relevant SOP.
• Provides input into CDMS development and requirements, assuring protocol requirements are met. Oversees and performs risk-based UAT on CDMS components as needed.
• Acquires knowledge related to drug development, clinical trials methodology, and applies the relevant information in recommending changes in data management to better satisfy business requirements.

Required Qualifications and Preferred Background

• Bachelor’s degree in life sciences, math, computer science or related field required. Advanced degree strongly preferred.
• Minimum of 5+ years’ clinical data management experience. 
• Minimum of 3 years’ Oncology/Hematology experience.
• Sponsor experience required.
• Demonstrated knowledge of drug development processes.
• Demonstrated project management skills.
• Demonstrated ability to effectively partner/influence cross functionally to deliver results.
• Thoroughand broad knowledge of data management processes, including EDC and interactive voice response system (IVRS)experience.
• Knowledge of regulatory guidelines such as GCP, 21 CFR Part 11 etc.
• Knowledge of study data tabulation model (SDTM, ADaM, CDISC).
• Must have excellent verbal, written and communication skills.
• Ability to work independently as well as in a team environment.
• Excellent time management skills and a proven ability to work on multiple projects at any given time in a fast-paced environment.
• Demonstrated ability to stay abreast of trends and new information in the profession.

Additional Preferences

• Managing or Oversight of healthy subject/clinical pharmacology studies.
• Line Management experience is a plus.




Loxo Oncology, Inc. (Loxo) currently anticipates that the base salary for the Manager level position could range from between $103,200 to $151,423 and anticipates that the base salary for the Senior Manager level position could range from between $118,700 to $174,137 but will depend, in part, on the successful candidate’s qualifications for the role, including education and experience. This position will also be eligible for a company bonus (depending, in part, on company and individual performance).  In addition, Loxo provides a comprehensive benefit program to eligible employees, including vacation, medical, dental and vision benefits; participation in a 401(k) plan; life and accidental death and disability coverage; parental leave benefits and employee discounts for certain items.  The compensation described above is subject to change and could be higher or lower than the range described.

Roles and Responsibilities of the Position

• Manage scope and support creation of a global integrated development plan that articulates the strategy for the molecule and provides the foundation for operational objectives
• Create and execute project plans and delivery of project milestones
• Develop and implement team communication plans and drive communication of key decisions/results to stakeholders
• Drive development of a global integrated project budget that ensures alignment with functional representatives and leadership
• Proficient in self-management and organizational skills; able to manage workload, set personal and team priorities and adjust as needed
• Strong interpersonal and teambuilding skills; able to develop effective teamwork between team members with diverse styles
• Lead development teams with judgment-based decisions
• Project Management Tools/IT Management:
• Provide quality and timely content using project management tools
• Monitor and prioritize team risks to suggest ways to avoid/mitigate risks and initiate contingency plans as needed
• Leads through shared learning, process improvement, and identification of special/complex needs
• Bring forward areas for continual process improvement to decrease drug development cycle times and cost
• Liaise with Project Management Office (PMO) and Resource Modeling and Forecasting (RMF) teams to identify, share, and incorporate best practices into future processes, tools and training

Required Qualifications and Preferred Background

• Bachelor’s degree required with preference for concentration of studies in health-related, scientific or engineering field; advanced degree or PM certification (e.g., MS., MBA, Master’s degree in Project Management or PMP) strongly advantageous
• 5 years of work experience in the pharmaceutical industry, drug development, and/or project management.
• Knowledge of or previous experience with drug development processes and application of project management tools and processes in cross-functional settings
• Proficiency with Microsoft Word, Excel, PowerPoint, Project and capable of maintaining appropriate project documentation




Loxo Oncology, Inc. (Loxo) currently anticipates that the base salary for the Manager level position could range from between $103,200 to $151,423 and anticipates that the base salary for the Senior Manager level position could range from between $118,700 to $174,137 but will depend, in part, on the successful candidate’s qualifications for the role, including education and experience. This position will also be eligible for a company bonus (depending, in part, on company and individual performance).  In addition, Loxo provides a comprehensive benefit program to eligible employees, including vacation, medical, dental and vision benefits; participation in a 401(k) plan; life and accidental death and disability coverage; parental leave benefits and employee discounts for certain items.  The compensation described above is subject to change and could be higher or lower than the range described.

Available locations for this role

• US-Based Remote
• South San Francisco, CA
• Stamford, CT
• Indianapolis, IN

Roles and Responsibilities of the Position:

• Interact and collaborate with various discovery technologies functional teams to develop and implement novel gene expression, genomic, and protein expression platforms
• Work collaboratively with the discovery and clinical teams to support retrospective and exploratory efforts for clinical programs
• Stay current on cutting edge technologies and work collaboratively with automation specialist to validate and implement new sequencing library construction.
• Develop and implement sequencing applications related to single cell and FFPE sequencing
• Support existing and novel targeted panel development for NGS
• Provide scientific expertise on practical implementation of various sequencing applications to support projects across the entire Loxo organization
• Establish protocol QC methods and standards to ensure quality data and analyses from a variety of high throughput, high content genomic, transcriptomic, and proteomic platforms
• Responsible for establishing and updating lab SOPs and training lab scientists as needed
• Work with the entire molecular characterization team to ensure all instrumentation is properly maintained and calibrated
• Proper documentation and archiving of data and analyses
• Work interactively with project teams and discovery informatics to plan and execute experiments as well as be involved in data interpretation and preparation of study reports.
• Work interactively with project teams and discovery informatics as a genomics expert to ensure appropriate applications and priorities are considered
• Additional roles and responsibilities:
·       Communicate results via written and oral presentations as needed
·       Discuss results with technical as well as non-technical personnel
·       Support archiving as well as curating data in internal databases
·       Extensive cross functional communication and collaboration with internal and external parties
·       Interrogate experimental conduct of third parties/vendors

Required Qualifications and Background:

• PhD in biological sciences with 5+ years  of experience with a focus in next generation sequencing or MSc in biological sciences with 10+ years experience with a focus in next generation sequencing experience, preferably in the pharma/biotech industry Extensive working expertise with a wide variety of Illumina library construction protocols.
• Broad experience with multiple nucleic acid and protein analysis platforms, including assay design and development
• Experience with high content, high throughput laboratory workflows with emphasis on quality and efficiency
• Demonstrated experience in working collaboratively across various scientific disciplines to meet project goals and timelines
• Flexibility to adjust priorities over time to meet organizational and scientific goals
• Ability to work independently and as an integral part of a larger collaborative team
• Demonstrated ability to succeed in a fast-paced environment, working on multiple projects with constantly changing priorities and deadlines
• Excellent interpersonal, written, and verbal communication skills
• Knowledge and experience documenting and processing clinical samples
• Experience with Spotfire data visualization software and pathway analysis tools

Preferred Qualifications:

• Experience with development of novel targeted panel with knowledge of probes, and indexes design is desirable
• Experience with FFPE, ctDNA and single cell library construction is desirable
• Working knowledge of automated liquid handling platforms, especially Hamilton, is beneficial
• Experience working in a GLP environment is a plus
• Experience with isolation and QC of nucleic acids from different sources like cell lines, specialized mouse/human tissues like bone marrow, FFPE samples and cryosections is an advantage
• Experience processing, analyzing, and interpreting large biological data sets

Role and Responsibilities of the Postion

• Work collaboratively with process chemistry, analytical, DMPK, toxicology, and pharmacology to develop and deliver appropriate drug products for different phases of development.
• Design, plan and execute experiments related to preformulation, characterization of API and the design of formulations such as suspensions, solutions, tablets, capsules, and spray dried dispersions.
• Manage and assist in development of appropriate analytical test methods and stability studies for drug product formulations.
• Maintain laboratory notebook, equipment and chemical inventory
• Provide written and verbal updates on assigned projects and activities as required.
• Author and review technical documents and formulation development reports.

Required Qualifications and Background

• Ph.D. in pharmaceutics, chemistry, material science, chemical engineering, or related discipline with 4-8 years experience, or Master’s with 6-10 years of experience, or a Bachelor’s degree with 8+ years pharmaceutical industry experience and a minimum of 8 years in a pharmaceutics and formulation development organization.
• Excellent scientific knowledge in pre-formulation, material science, and formulation development.
• A track record of successful development of oral solid dosage forms and enabled formulations is highly desired.
• Experience with solubility determination, compatibility studies, formulation screening, dissolution, polymorph screening and physicochemical characterization of API as well as formulations.
• Experience in instrumental techniques such as XRPD, DSC, TGA, DVS, HPLC, SEM and Dissolution.
• Experience in the formulation, process development and manufacturing of drug products.
• Demonstrated ability to work well with other accomplished professionals within and across functions/teams. Willing collaborator.
• Strong written and oral communication skills.
• Ability to multi-task and shift priorities rapidly to meet tight deadlines.
• Detail oriented and well organized.
• Good and thoughtful listener.
• Enthusiastic, self-motivated, and keen to improve processes and overcome inefficiencies.
• Proficient in Microsoft Office suite and applications. 


Loxo Oncology, Inc. (Loxo) currently anticipates that the base salary for the Principal Scientist position level could range from between $103,200 to $151,423 and the Senior Principal Scientist position level could range from between $118,700 to $174,137 and will depend, in part, on the successful candidate’s qualifications for the role, including education and experience. This position also will be eligible for a company bonus(depending, in part, on company and individual performance).  In addition, Loxo provides a comprehensive benefit program to eligible employees, including vacation, medical, dental and vision benefits; participation in a 401(k) plan; life and accidental death and disability coverage; parental leave benefits and employee discounts for certain items.  The compensation described above is subject to change and could be higher or lower than the range described above. Further, Loxo reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion.

Roles and Responsibilities for this Postion

• Design and execute in vitro and in vivo preclinical studies to understand the pharmacokinetics (PK) and absorption, metabolism, distribution, and excretion (ADME) of new chemical entities (NCE)
• Provide management and oversight of CROs in the conduct of in vitro and in vivo ADME studies
• Advise medicinal chemistry teams on complex DMPK issues
• Perform non-compartmental pharmacokinetic analysis on data
• Review in vivo protocols and study reports
• Collate data and present to program teams
• Contribute to authoring and review of regulatory reports and documents
• Maintain accurate and timely electronic lab notebook

• BS, MS or Ph.D. in medicinal chemistry, biochemistry or related discipline
• BS with 10+, MS with 8+ or Ph.D. with 5+ years of DMPK experience
• Experience managing and overseeing CROs
• Experience managing Bioanalytical and Pharmacokinetic studies strongly preferred
• Must have pharmacokinetic modeling experience
• Experience with bioanalysis method and assay development
• Good written and oral presentation capabilities

Available Locations for this Role

• Boulder/Louisville, Colorado
• Remote (US Based)




Loxo Oncology, Inc. (Loxo) currently anticipates that the base salary for the Principal Scientist position level could range from between $103,200 to $151,423 and that the base salary for the Senior Principal Scientist position level could range from between $118,700 to $174,137 will depend, in part, on the successful candidate’s qualifications for the role, including education and experience. This position will also be eligible for a company bonus (depending, in part, on company and individual performance).  In addition, Loxo provides a comprehensive benefit program to eligible employees, including vacation, medical, dental and vision benefits; participation in a 401(k) plan; life and accidental death and disability coverage; parental leave benefits and employee discounts for certain items.  The compensation described above is subject to change and could be higher or lower than the range described above. Further, Loxo reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion.

Roles and Responsibilities of the Position

• Facilitate in establishing and translating strategic program goals into project plan(s) with clearly outlining deliverables, milestones, and no-go decisions.
• Engage in establishing program strategic objectives by collaborating with Loxo Biologics’ leadership team.
• Engage with functional team leads of antibody discovery, translational, mechanistic biology, and protein engineering (and other key stakeholders) to plan, execute, and track project activities ensuring alignment of project deliverables with strategic goals.
• Actively facilitate project meetings with internal and external stakeholders (create agendas, minutes, and track action items).
• Proficient in adaptive communications; effectively manage communications vertically and horizontally in a cross-functional environment involving external and internal stakeholders.
• Proactively contribute and manage project communications. Identify gaps and ambiguities in communication channels and address them to maintain alignment across the team.
• Actively contribute to create project updates, reports, presentations, and memos and maintain project document repository.
• Identify and assess the needs for outsourcing, establish relationships with external collaborators, and manage alliances on an ongoing basis.
• Drive day-to-day operational activities by coordinating with stakeholders from different functional departments - legal/Business operations, procurement, finance, and other relevant functional areas.
• Proactively identify gaps in processes and actively create processes to meet program needs.
• Adaptive to change in priorities and able to drive project outcomes ensuring re-alignment with program deliverables in changing landscape.
• Contribute to implementing visions of building and operationalizing large molecule discovery labs.
• Contribute to building positive, collaborative teams across various scientific disciplines, and encouraging sharing of new ideas, and creative ways to solve problems often needed in discovery research.
• Support the creation of an organizational project framework for different functional groups and build operational guidelines and processes. 

Required Qualifications and Background

• Bachelor’s Degree in relevant scientific discipline (i.e.: Biology, Biochemistry, etc.) and a minimum of 7 years of direct project management/alliance management experience roles in cross-functional Biotech and pharmaceutical research environment. Prior experience is managing strategic program management in early phase large molecule discovery set up will be preferable. 
• Excellent verbal, written communication and interpersonal skills.
• Excellent organizational skills, efficient, with strong attention to detail.

Additional Preferred Qualifications

• Advanced degree in relevant scientific fields (e.g., Biology) strongly preferred.
• PMP certification is required.
• Experience managing projects in early stage, large molecule discovery in large molecule discovery operations.
• Understand distinctions between high-level program goals and day-today operations.
• Experience in managing external suppliers, vendors, and other external alliances.
• Ability to anticipate key challenges and proactively propose solutions.
• Adaptive to changes and apply creative problem-solving skill to meet project and other operational needs.
• Proficient in identifying and applying tools to effectively manage and track projects - MS Office suite, MS Project.
• Create and implement new tools and work towards creating and implementing processes customized for furthering discovery research.

Available locations for this role

• South San Francisco, CA
• US Based-Remote




Loxo Oncology, Inc. (Loxo) currently anticipates that the base salary for the Manager position level could range from between $103,200 to $151,423 and will depend, in part, on the successful candidate’s qualifications for the role, including education and experience. This position also will be eligible for a company bonus(depending, in part, on company and individual performance).  In addition, Loxo provides a comprehensive benefit program to eligible employees, including vacation, medical, dental and vision benefits; participation in a 401(k) plan; life and accidental death and disability coverage; parental leave benefits and employee discounts for certain items.  The compensation described above is subject to change and could be higher or lower than the range described above. Further, Loxo reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion.

Roles and Responsibilities for the position

• Stationed at the front desk assisting with queries, welcoming guests and receiving deliveries.
• Act as the face of Loxo West when greeting visitors, including candidates for employment, and work closely with the team to ensure interviews and meetings remain on schedule.
• Monitor security cameras and door intercoms.
• Answer main telephone lines and direct internal and external calls.
• Coordinate and facilitate the use of all conference rooms
• Assist with ordering, set up and clean-up of office lunches (and dinners when necessary).
• Restock kitchen supplies daily (or more frequently depending on need).
• Clean and restock the coffee machine weekly (or more frequently depending on need).
• Send and receive packages via USPS, UPS and FedEx.
• Collect and distribute the mail daily (or more frequently depending on need).
• Maintain copy rooms and printers/copiers in coordination with the IT team.
• Assist with other special projects as needed, including assisting with offsite meetings, events, large print/copy jobs, IT projects, coordinating external vendors, moving furniture etc.
• Act as a back-up for administrative duties during absences and leaves, as needed, including meeting coordination, calendar management, booking travel, reconciling expenses and other administrative tasks.

Required Qualifications and Background

• Minimum of 3+ years in a comparable Reception/Administrative/ Office Coordinator / Assistant / Receptionist role.
• Positive, eager and helpful attitude.
• Professional demeanor and appearance and excellent written and verbal communication skills.
• Able to work within a fast-paced environment, adept at juggling multiple tasks and priorities and prioritizing independently.
• Enthusiastic, self-motivated and keen to improve processes and overcome inefficiencies.
• Effective collaborator with a variety of stakeholders, and a thoughtful listener and team player.
• Able to maintain a calm, patient and “can-do” approach.
• Conscientious, detail-oriented, well-organized and takes initiative to anticipate and address needs.
• Able to bring a proactive and creative approach to problem solving.
• Proficient in Microsoft Office suite and applications.


*This role requires and an on-site presence from 8:30AM-5:00PM, Monday to Friday, and occasionally additional hours if needed.

Roles and Responsibilties of the Position

• Perform high-throughput antibody binding screens by ELISA and multi-plex flow cytometry to identify hits
• Develop, optimize, and perform in vitro potency assays to deliver key data for selecting lead panel of antibodies, including bispecific antibodies and antibody drug conjugates
• Perform tissue cultures to expand and maintain mammalian cell lines and primary immune cells for in vitro assays and antibody/protein expression
• Work collaboratively with Discovery Biologics functional teams to ensure materials and results are delivered on time
• Demonstrate collection and thorough analysis of data, and update Electronic Notebook records

Required Qualifications and Background:

• MS in Biology, Biochemistry, Biomedical Engineering, or related field with minimum of 3+ years of industry experience, or BS with 5+ years of industry experience in biologics drug discovery
• Must have in tissue cultures experience using mammalian cell lines and primary immune cells using aseptic laboratory techniques
• Experience in operating and maintaining flow cytometers, plate readers, and liquid handlers, as well as software for data analysis and visualization (Microsoft Office and GraphPad Prism)
• Highly motivated, fast learner with strong organization skills
• Demonstrate experience in working collaboratively across various scientific disciplines to meet end goals of business
• Demonstrate ability to succeed in a fast-paced environment, working on multiple projects with constantly changing priorities and deadlines
• Excellent written and verbal communication skills
• Strong interpersonal skills

Preferred Qualifications:

• Single B cell cloning or hybridoma based antibody discovery experience


Loxo Oncology, Inc. (Loxo) currently anticipates that the base salary for the Scientist position level could range from between $78,000 to $114,498 and will depend, in part, on the successful candidate’s qualifications for the role, including education and experience. This position will also be eligible for a company bonus (depending, in part, on company and individual performance).  In addition, Loxo provides a comprehensive benefit program to eligible employees, including vacation, medical, dental and vision benefits; participation in a 401(k) plan; life and accidental death and disability coverage; parental leave benefits and employee discounts for certain items.  The compensation described above is subject to change and could be higher or lower than the range described above. Further, Loxo reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion.

Roles and Responsibilities of the Position

• Design and clone recombinant antibody and protein expression constructs to support therapeutic antibody discovery programs
• Generate recombinant antibodies and proteins in mammalian cells, and perform small-scale purification and analysis
• Design and execute antibody discovery campaigns by phage display
• Perform high-throughput antibody binding screens by ELISA and multi-plex flow cytometry to identify hits
• Work collaboratively with Discovery Biologics functional teams to ensure results are delivered on time
• Demonstrate collection and thorough analysis of data, and update Electronic Notebook records

Required Qualifications and Background:

• MS in Biology, Biochemistry, Biomedical Engineering, or related field with minimum of 3+ years of industry experience, or BS with 5+ years of industry experience in biologics drug discovery
• Strong molecular biology skills, including molecular cloning, multi-piece DNA assembly, site-directed mutagenesis, reformatting antibody constructs, and HT sequence analysis
• Must have protein expression and purification background using mammalian cells
• Experience in operating and maintaining AKTA, HPLC, liquid handlers, as well as software for data analysis and visualization (Microsoft Office and GraphPad Prism)
• Highly motivated, fast learner with strong organization skills
• Demonstrate experience in working collaboratively across various scientific disciplines to meet end goals of business
• Demonstrate ability to succeed in a fast-paced environment, working on multiple projects with constantly changing priorities and deadlines
• Excellent written and verbal communication skills
• Strong interpersonal skills

Preferred Qualifications:

• Previous experience in NGS and biophysical characterization for antibody discovery and engineering
• Experience in bioinformatics tool development for large molecule drug discovery is highly desired
• Experience in library design for phage and/or yeast display

Roles and Responsibilities of the Position

• Provide recombinant protein expression/purification support for enzymology, biophysical characterization, bioassay and structural biology.
• Execute projects in an efficient manner, working with aggressive timelines.
• Rapidly communicate scientific results and insights to the team.
• Prepare reports for internal and external purposes including regulatory submissions.
• Participate and lead project-based and technical team meetings to identify and solve problems, guide work towards project goals, communicate on-going work and progress, and plan forward thinking strategies.
• Continually advance your understanding of current methodology and new/emerging technologies by reading scientific literature.
• Proactively investigate new or different technologies, methods, and service providers to ensure our work is being done in a scientifically sound, efficient, and reasonable way

Required Qualifications and Background

• BA/BS/MS/PhD in biology, genetics, biochemistry, molecular biology or a related field along with hands-on experience, working in a  laboratory in a biotech/pharma setting, 0-3 years’ experience with a PhD; 3-5 years’ experience with an MS degree; 5+ years’ experience with BS/BA degree;  may also consider experience out of an academic/research setting.
• Experience in a gene to structure research setting is a plus.
• Expertise with protein purification techniques such as IMAC, SEC, IEX and affinity chromatography is required, ideally utilizing the Akta FPLC systems.
• Experience with a variety of protein expression systems (E.coli, BV, mammalian) as well as modern cloning technologies is preferred
• Expertise with protein characterization techniques such as LCMS, western blotting, and thermal melt  assays  is desirable.
• Familiarity with biophysical techniques such as SPR, ITC, Fluorescent binding assays, enzyme kinetic assays is a plus.
• The candidate must be self-motivated but always maintain focus on why we are here and who is important i.e. the patients and their families/caregivers.
• Excellent interpersonal skills with ability to communicate and interact well with colleagues, vendors, contractors, scientific advisors, and staff at all levels.
• Desire to cross-train and flex between sub-groups (protein expression/purification/characterization) is a must.
• Highly organized with excellent analytical, documentation and multi-tasking skills.


Loxo Oncology, Inc. (Loxo) currently anticipates that the base salary for Scientist level could range from between $78,000 to $114,498 will depend, in part, on the successful candidate’s qualifications for the role, including education and experience. This position will also be eligible for a company bonus (depending, in part, on company and individual performance).  In addition, Loxo provides a comprehensive benefit program to eligible employees, including vacation, medical, dental and vision benefits; participation in a 401(k) plan; life and accidental death and disability coverage; parental leave benefits and employee discounts for certain items.  The compensation described above is subject to change and could be higher or lower than the range described above. Further, Loxo reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion.

Roles and Responsibilities

• Develop purification protocols to for recombinant proteins for multiple projects simultaneously, within the protein sciences group to provide high quality proteins for structural biology, mechanistic biology, biophysics, and bioassay.
• Execute projects in an efficient manner, working with aggressive timelines.
• Understand overarching priorities and workflows, to deliver proteins accordingly.
• Rapidly communicate scientific results and insights to the team.
• Prepare reports for internal and external purposes
• Participate in project-based and technical team meetings to identify and solve problems, guide work towards project goals, communicate on-going work and progress, and plan forward thinking strategies.
• Continually advance your understanding of current methodology and new/emerging technologies by reading scientific literature.
• Proactively investigate new or different technologies, methods, and service providers to ensure our work is being done in a scientifically sound, efficient, and reasonable way

• BA/BS/MS/PhD in protein sciences, biochemistry, biology, molecular biology, or a related field.
• Ideal candidate will have 3+ years of hands-on laboratory experience working in a biotech/pharma setting.
• Expertise with protein purification techniques such as IMAC, SEC, IEX and affinity chromatography is required, ideally utilizing the AKTA FPLC systems.
• Experience developing purification protocols for new projects is highly desirable.
• Experience with a wide variety of protein families of various complexity is an asset.
• Ability to multi-task for parallel processing of multiple samples and to optimize protein homogeneity, stability and yields.
• Experience with recalcitrant proteins is highly desirable.
• Desire to apply innovative approaches to challenging problems and brain-storm cross-functionally to solve the problem at hand.
• Expertise with protein characterization techniques such as LCMS, western blotting, and thermal melt assays is desirable.
• Attention to detail for record keeping and QC is essential.
• Familiarity with biophysical techniques such as SPR, ITC, fluorescent binding assays, enzyme kinetic assays is a plus.
• Experience with purification from a variety of protein expression systems (E.coli, BV, mammalian) is beneficial.
• Experience in a gene-to-structure research setting is a plus.
• The candidate must be self-motivated but always maintain focus on why we are here and who is important i.e. the patients and their families/caregivers.
• Excellent interpersonal skills with ability to communicate and interact well with colleagues, vendors, contractors, scientific advisors, and staff at all levels.
• Desire to cross-train and flex between the protein sciences sub-groups (protein expression/purification/characterization) is preferred.
• Willingness to openly share knowledge and mentor colleagues is required for the success of the team.
• Highly organized with excellent analytical, documentation and multi-tasking skills.
Loxo Oncology, Inc. (Loxo) currently anticipates that the base salary for the Scientist level position could range from between $78,000 to $114,498 and the Senior Scientist level position could range from between $89,750 to $131,672 and will depend, in part, on the successful candidate’s qualifications for the role, including education and experience. This position will also be eligible for a company bonus (depending, in part, on company and individual performance).  In addition, Loxo provides a comprehensive benefit program to eligible employees, including vacation, medical, dental and vision benefits; participation in a 401(k) plan; life and accidental death and disability coverage; parental leave benefits and employee discounts for certain items.  The compensation described above is subject to change and could be higher or lower than the range described above. Further, Loxo reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion.

Roles and Responsibilities of the Position

• Create, develop, and validate quantitative cellular assays to address the project team’s needs.
• Establish robust screening assays to support medicinal chemistry lead optimization programs.
• Implement, troubleshoot, and operate high precision instruments and laboratory automation
• Generate processes to execute efficiently and effectively communicate results to the project team under a strict timeline.
• Collaborate with colleagues throughout the company to ensure assays meet the program needs and timelines and results are appropriately interpreted.
• Prepare reports for internal and external purposes including regulatory submissions.
• Participate and lead project-based and technical team meetings to identify and solve problems, guide work towards project goals, communicate on-going work and progress, and plan forward thinking strategies.
• Great attention to detail and knowledge of scientific writing conventions
• Able to identify, evaluate, and manage vendors for outsourced services and studies.
• Proactively investigate new or different technologies, methods, and service providers to ensure our work is being done in a scientifically sound, efficient, and reasonable way.

Required Qualifications and Background

• Required:
• PhD in Molecular/Cellular Biology or Biochemistry, or related field with either 3+ years hands-on cell biology experience AND either 2+ years post-doctoral experience or 1+ years work experience in a biotech/pharma setting OR 5+ years hands-on cell biology experience OR
• BS/MS in Molecular/Cellular Biology or Biochemistry with either 3+ hands-on cell biology experience AND 4+ years work experience in a biotech/pharma setting or 8+ years hands-on cell biology experience


• Ideal candidate will also have:
• Extensive experience in creating, developing, and running cellular assays monitoring various kinetic parameters and/or endpoints outputs.
• Experience with general molecular biological techniques including q-PCR, ELISA, MSD, Western Blot, In-Cell Western, etc.
• Strong background in experimental curve-fitting and statistics.
• Excellent interpersonal skills with ability to communicate and interact well with colleagues, vendors, contractors, scientific advisors, and staff at all levels.
• Highly organized with excellent analytical and documentation skills.
• Ability to multi-task and shift priorities rapidly to meet tight deadlines.
• Committed to staying current with the latest scientific breakthroughs in the targeted oncology field from target identification through human clinical trials.
• Good and thoughtful listener who values collaboration.
• Enthusiastic, self-motivated, and keen to improve processes and overcome inefficiencies.
• Proficient in Microsoft Office suite and analysis-specific applications (e.g., Prism, GeneData, SLD).

Additional Preferred Qualifications

• Previous experience with cell line development (lentiviral generation and transduction, single cell sorting, CRISPR, etc).
• Knowledge of various liquid handlers and acoustic dispensers.
• Hands-on experience with 384-/1536-well format.
• Prior supervisory function and management skills.


Loxo Oncology, Inc. (Loxo) currently anticipates that the base salary for the Scientist position could range from between $78,000 to $114, 498 and the base salary for the Senior Scientist could range from between $89,750 to $131,672 but will depend, in part, on the successful candidate’s qualifications for the role, including education and experience. This position will also be eligible for a company bonus(depending, in part, on company and individual performance).  In addition, Loxo provides a comprehensive benefit program to eligible employees, including vacation, medical, dental and vision benefits; participation in a 401(k) plan; life and accidental death and disability coverage; parental leave benefits and employee discounts for certain items.  The compensation described above is subject to change and could be higher or lower than the range described above. Further, Loxo reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion.

Role and Responsibilities of the Position

• Work collaboratively with process chemistry, analytical, DMPK, toxicology, and pharmacology to develop and deliver appropriate drug products for different phases of development.
• Plan and conduct experiments on pre-formulation, characterization of API and the design of formulations such as suspensions, solutions, tablets, capsules, and spray dried dispersions
• Assist in development of appropriate analytical test methods and stability studies for drug product formulations
• Maintain laboratory equipment and chemical inventory
• Provide written and verbal updates on assigned projects and activities as required
• Author and review technical documents and formulation development reports.

Required Qualifications and Backgroun

• Ph.D. in pharmaceutics, chemistry, material science, chemical engineering, or related discipline with 0-2 years experience, or Master’s degree with 1-3 years of experience, or a Bachelor’s degree with 1-5 years pharmaceutical industry experience.
• Excellent scientific knowledge in pre-formulation, material science, and formulation.
• Experience with solubility determination, compatibility studies, formulation screening, dissolution, polymorph screening and physicochemical characterization of API as well as formulations.
• Experience in instrumental techniques such as XRPD, DSC, TGA, DVS, HPLC, SEM and Dissolution is highly desired.
• Experience in the formulation, process development and manufacturing of drug products.
• Demonstrated ability to work well with other accomplished professionals within and across functions/teams.
• Strong written and oral communication skills.
• Ability to multi-task and shift priorities rapidly to meet tight deadlines.
• Detail oriented and well organized.
• Good and thoughtful listener.
• Enthusiastic, self-motivated, and keen to improve processes, overcome inefficiencies and able to adapt to changing environment with ease.
• Proficient in Microsoft Office suite and applications. 


Loxo Oncology, Inc. (Loxo) currently anticipates that the base salary for the Scientist level position could range from between $78,000 to $114,498 and the Senior Scientist level position could range from between $89,750 to $131,672 and will depend, in part, on the successful candidate’s qualifications for the role, including education and experience. This position will also be eligible for a company bonus (depending, in part, on company and individual performance).  In addition, Loxo provides a comprehensive benefit program to eligible employees, including vacation, medical, dental and vision benefits; participation in a 401(k) plan; life and accidental death and disability coverage; parental leave benefits and employee discounts for certain items.  The compensation described above is subject to change and could be higher or lower than the range described above. Further, Loxo reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion.

Roles and Responsibilities of the Position

• The ideal candidate should have experience in protein biochemistry and proteomic techniques. Experience with proteomics sample preparation (i.e., proteolytic digestion, solid phase extraction, immunoprecipitation) and operation of an Orbitrap mass spectrometer are preferred, but not essential for success in this role. Additionally, this position will be asked to evaluate technologies and techniques to evaluate protein structure dynamics, such as HDX or hyroxy-radical footprinting.  Computational skills are highly desirable. Strong communication & interpersonal skills are essential for success in this collaborative role.

Required Qualifications and Preferred Background

• BS, MS, or PhD in a Life Sciences discipline, with training in molecular biology, enzymology or biochemistry, and a record of lab based independent research experience along with a minimum of 10 years for BS, >5 years for MS and >0-3 years for PhD, either in industrial or academic environment. The ideal candidate will have hands-on experience with protein characterization and cell culture.
• Demonstrated ability to work well with other accomplished professionals within and across functions/teams. Willing collaborator.
• Familiarity with techniques and instrumentation relevant to automated semi-automated sample handling
• Excellent interpersonal skills with ability to communicate and interact well with colleagues, vendors, contractors, scientific advisors, and staff at all levels.
• Highly organized with excellent analytical, documentation and multi-tasking skills
• Committed to staying current with the latest scientific breakthroughs in structure-based drug design and proteomics and related technology. A continuous learner.
• Expertise in other methods of enzymology or biophysical characterization and structural biology is a plus


Loxo Oncology, Inc. (Loxo) currently anticipates that the base salary for the Scientist level could range from between $78,000 to $114,498 and that the base salary for the Senior Scientist could range from between $89,750 and $131,672 but will depend, in part, on the successful candidate’s qualifications for the role, including education and experience. This position will also be eligible for a company bonus (depending, in part, on company and individual performance).  In addition, Loxo provides a comprehensive benefit program to eligible employees, including vacation, medical, dental and vision benefits; participation in a 401(k) plan; life and accidental death and disability coverage; parental leave benefits and employee discounts for certain items.  The compensation described above is subject to change and could be higher or lower than the range described above. Further, Loxo reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion.

Roles and Responsibilities for the Position

• Work collaboratively with process chemistry, pharmaceutics, and medicinal chemistry to develop drug substance (DS) and drug product (DP) analytical methods
• Develop stability indicating HPLC methods in support of candidate molecules and formulations
• Develop assay, related substance, dissolution, Karl Fischer, residual solvent and  chiral purity methods for transfer to external laboratories
• Perform pre-validation studies to demonstrate the effectiveness of analytical methodology to accurately characterize drug substance and drug product physicochemical and performance characteristics
• Author and review technical documents including analytical development reports and CMC sections for IND, IMPD and global marketing applications
• Monitor and evaluate data from drug product and drug substance stability studies
• Perform laboratory activities including instrument trouble-shooting, instrument maintenance, and chemical inventory
• Manage multiple projects, set priorities, and work in a fast-paced environment
• Laboratory operations including ordering supplies, maintaining inventory of laboratory consumables
• Design and implement studies to evaluate the physical and chemical stability of drug substance and prototype drug product formulations, including forced degradation, excipient compatibility 

Required Qualifications and Background

• BS in analytical chemistry or related discipline with 5+ years of experience, MS with 2+ years experience, or Ph.D. with 0+ years experience in the pharmaceutical industry
• Requires a strong background in analytical method development, applying analytical techniques to solve challenging problems, and experience in stability study design and data management
• Manage and compile stability data generated from internal and external laboratories with respect to product performance and trending
• Demonstrated proficiency in both hands-on analytical work, as well as managing activities, reviewing and organizing analytical data and solving analytical challenges
• Instrument maintenance, including trouble shooting and repair, as well as managing instrument specific vendor support
• Instrument maintenance, including HPLC, GC, FTIR, KF, Mass Spectrometry, and other analytical instrumentation common to pharmaceutical laboratories.
• Experience authoring and reviewing technical documents including, but not limited to, development reports, analytical test methods, specifications, and evaluation of stability data
• In-depth knowledge of USP/Ph. Eur, ICH and cGMP requirements
• Demonstrated ability to work well with other accomplished professionals within and across functions/teams.
• Strong written and oral communication skills
• Ability to multi-task and shift priorities rapidly to meet tight deadlines
• Self-motivated, and keen to improve processes and overcome inefficiencies
• Proficient in Microsoft Office suite and applications


Loxo Oncology, Inc. (Loxo) currently anticipates that the base salary for the Scientist level position could range from between $78,000 to $114,498 and the Senior Scientist level position could range from between $89,750 to $131,672 and will depend, in part, on the successful candidate’s qualifications for the role, including education and experience. This position will also be eligible for a company bonus (depending, in part, on company and individual performance).  In addition, Loxo provides a comprehensive benefit program to eligible employees, including vacation, medical, dental and vision benefits; participation in a 401(k) plan; life and accidental death and disability coverage; parental leave benefits and employee discounts for certain items.  The compensation described above is subject to change and could be higher or lower than the range described above. Further, Loxo reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion.

Roles and Responsibilities of the Position

• Diagnose the cause of technical problems in a complex environment and provide effective solutions quickly
• Gain and maintain expertise in all company and locally used IT applications and procedures
• Train helpdesk team, end users and IT staff on IT applications and procedures
• Partner with colleagues on joint projects and tasks
• Provide ongoing and weekly updates on all tasks, projects, and support issues to Associate Director, IT Applications
• Interface and maintain relationships with strategic IT vendors on business-critical applications and infrastructure to ensure smooth implementation as well as best value for the organization.
• Partner with users as needed regarding critical business applications to provide guidance and support.
• Act as administrator for a variety of applications

Required Qualifications and Background

• Experience working in Life Sciences preferred
• Programming background a plus
• Demonstrated ability to work well with other accomplished professionals within and across functions/teams. Willing collaborator.
• Strong written and oral communication skills
• Ability to multi-task and shift priorities rapidly to meet tight deadlines
• Excellent written and verbal communicator
• Proficient in Microsoft Office suite and applications




Loxo Oncology, Inc. (Loxo) currently anticipates that the base salary for the Specialist level position could range from between $67,850 to $99,563 and will depend, in part, on the successful candidate’s qualifications for the role, including education and experience. This position will also be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Loxo provides a comprehensive benefit program to eligible employees, including vacation, medical, dental and vision benefits; participation in a 401(k) plan; life and accidental death and disability coverage; parental leave benefits and employee discounts for certain items. The compensation described above is subject to change and could be higher or lower than the range described.

Roles and Responsibilities of the Position

• Maintain and establish various mammalian cell lines used to credential novel targets.
• Perform cellular and biochemical assays to evaluate the outcome of various genetic or chemical perturbations.    
• Analyze, interpret, and present the data to the team and/or organization.
• Troubleshoot experiments in a timely manner.
• Learn and apply new techniques to support ongoing efforts.
• Actively participate in group discussions and collaborate with colleagues throughout the organization.
• Contribute to a safe and efficient workplace. 

Required Qualifications and Background

• BS, MS, or PhD in biology, cancer, molecular biology, cell biology, biochemistry, or related discipline, with 3+ years lab-based experience.
• Expertise in routine molecular and cellular techniques.
• Experience in gene editing (CRISPR, TALEN, etc.) and/or high-throughput screening is a plus.
• Excellent collaborative and interpersonal skills.
• Highly organized, detail-oriented, self-motivated and strong documentation skills.
• Outstanding communication, writing, and presentation skills are a must.

Available locations for this role

• Loxo Oncology, Inc. (Loxo) currently anticipates that the base salary for the Senior Associate Scientist position level could range from between $67,850 to $99,563 and will depend, in part, on the successful candidate’s qualifications for the role, including education and experience. This position also will be eligible for a company bonus(depending, in part, on company and individual performance).  In addition, Loxo provides a comprehensive benefit program to eligible employees, including vacation, medical, dental and vision benefits; participation in a 401(k) plan; life and accidental death and disability coverage; parental leave benefits and employee discounts for certain items.  The compensation described above is subject to change and could be higher or lower than the range described above. Further, Loxo reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion.

Roles and Responsibilities of the Position

• Maintain and establish various mammalian cell lines used to credential novel targets.
• Perform cellular and biochemical assays to evaluate the outcome of various genetic or chemical perturbations.    
• Analyze, interpret, and present the data to the team and/or organization.
• Troubleshoot experiments in a timely manner.
• Learn and apply new techniques to support ongoing efforts.
• Actively participate in group discussions and collaborate with colleagues throughout the organization.
• Contribute to a safe and efficient workplace. 

Required Qualifications and Background

• BS, MS, or PhD in biology, cancer, molecular biology, cell biology, biochemistry, or related discipline, with 3+ years lab-based experience.
• Expertise in routine molecular and cellular techniques.
• Experience in gene editing (CRISPR, TALEN, etc.) and/or high-throughput screening is a plus.
• Excellent collaborative and interpersonal skills.
• Highly organized, detail-oriented, self-motivated and strong documentation skills.
• Outstanding communication, writing, and presentation skills are a must.

Available locations for this role

• Boulder, CO




Loxo Oncology, Inc. (Loxo) currently anticipates that the base salary for the Senior Associate Scientist position level could range from between $67,850 to $99,563 and that the base salary for the Scientist position level could range from between $78,000 to $114,498 and will depend, in part, on the successful candidate’s qualifications for the role, including education and experience. This position also will be eligible for a company bonus(depending, in part, on company and individual performance).  In addition, Loxo provides a comprehensive benefit program to eligible employees, including vacation, medical, dental and vision benefits; participation in a 401(k) plan; life and accidental death and disability coverage; parental leave benefits and employee discounts for certain items.  The compensation described above is subject to change and could be higher or lower than the range described above. Further, Loxo reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion.

Role and Responsibilities for the Position

• Serve as primary regulatory subject matter expert in Dx/CDx development.
• Serve as the regulatory representative on the Lilly Oncology CDx leadership team.
• Takes leadership role in industry groups to influence CDx regulatory policy
• Responsible to help coordinate deliverables for regulatory agencies meetings (FDA, EMA/CHMP, Japan PMDA, China NMPA, etc…) that may include diagnostic partners and internal Dx/CDx and Rx teams.
• Work with Rx Regulatory and Dx/CDx Development colleagues to determine best practices related to biomarker testing towards clinical development & global registration activities.
• Identify potential impact of relevant Rx and Dx/CDx regulations on Rx and CDx development &/or registration activities for late-stage oncology programs, respectively.
• Provide project coordination/oversight towards biomarker testing or Dx/CDx regulatory deliverables (e.g. SRD, IDE, CDRH pre-subs, CDER briefing documents for FDA meetings), technical feedback on Dx/CDx analytical/clinical or bridging study plans, regulatory support, strategic guidance and advisement on project teams.
• Help develop regulatory strategies related to Biomarker testing to enable timely Rx regulatory submissions and approvals by regulatory agencies (e.g., NDA/sNDA), synchronizing with the Rx development plan.
• Coordinate and support CDx development leads on interactions with diagnostic partners or testing laboratories to mutually align on regulatory needs and expectations for biomarker testing and Rx study endpoints.
• Help coordinate interactions with FDA/CDRH and other health authorities (HA)
• Generate/draft SRD, CDRH pre-subs and sections of CDER/EMA briefing documents as needed to support Rx Clinical Strategies.
• Review and approve key regulatory deliverables generated for biomarker testing (i.e., bridging study protocols and reports) samples in collaboration with bio specimen teams.
• Coordinate Dx/CDx regulatory team meeting schedules, agendas, and meeting minutes.
• Support Dx/CDx teams on contracts, budgets, project and development timelines.
• Maintain knowledge of applicable Dx/CDx regulatory requirements and scientific/technical issues relevant to assigned projects.
• Work with Rx regulatory team members to align all biomarker/CDx regulatory needs.
• Work with Dx/CDx Program Management to support the development and maintenance of high level and detailed Biomarker/Dx/CDx timelines to assure that the functional timelines are aligned with global program timelines.
• Bring issues to Manager, Project Team leaders or other individual’s attention when necessary and participate in the resolution of delays or potential delays.
• Respond to changing duties as responsibilities may vary based on potential pipeline growth, project needs, and stages of development (pre- clinical, clinical or commercial).

Required Qualifications and Background

• B.S. degree required, preferably in a health-related field. Advanced degree (MS, PhD or PharmD) strongly preferred.
• Minimum of 10 years of related work experience in Biotech/Pharma, Diagnostic or Laboratory (e.g., GCP/GMP, CLIA environments).  Minimum of 4 years regulatory experience.
• Strong understanding/knowledge/experience of CDx development and Biomarker testing required (PCR, IHC/ISH or NGS).
• Previous personnel leadership preferred
• Prior therapeutic or diagnostic study protocol and ICF review experience required.
• Knowledge of international (EU, Japan, China) CDx requlations a plus
• Knowledge of ICH and local regulatory authority regulations regarding drug trials a plus.
• Familiar with planning and execution of biomarker testing to meet patient eligibility and clinical sample collection requirements.
• Ability to identify or help identify potential challenges/risks associated with biomarker testing to meet study protocol requirements (eg, patient eligibility) and clinical sample collection requirements.
• High level of integrity, accuracy, and attention to detail.
• Self-organized, self-directed, highly motivated with strong critical thinking and analytical skills.
• Willingness to work collaboratively, think critically, and incorporate diverse perspectives into decision-making.
• Demonstrated ability to work successfully in a nimble, fast-paced matrixed environment. Able to function effectively in a team setting within Eli Lilly and Loxo@Lilly.
• Proficiency with Microsoft Office. Experience with Microsoft Office Project a plus. 
• Outstanding interpersonal, communication and negotiation skills.
• Demonstrated ability to guide/coach teams to timely achievement of objectives.

Available Locations for this role

• Stamford, CT
• South San Francisco, CA
• US Based-Remote

Roles and Responsibilities of the Position

• Oversee the strategic planning and development for all aspects of biostatistical activities across a significant portion of Loxo programs.
• Ensure the use of suitable statistical methodologies. Model and guide appropriate and clear statistical interpretation of analyses and data.
• Responsible for clear communication of statistical methodology and implications of its use to cross functional team members in both planning and interpretation stages of development.
• Evaluate and oversee statistical vendors and consultants as needed. Build close, strategic and productive relationships with statistical vendors. Maintain transparent communication with all biostatistics vendors and partners enabling timely and quality deliverables to support flexible resourcing and growing pipeline.
• Represent biostatistics function/department in cross functional teams while also ensuring within function alignment.
• Incorporate broad, cross functional understanding of the drug development process into proposed statistical analysis, interpretation and synthesis of data, and recommendations to the project team (e.g. including cost, time, risk/opportunity, benefit to subjects, probability of success…)
• Participate in regulatory interactions, development of strategy of, text and outputs for regulatory question responses.
• Responsible for the overall quality of biostatistics deliverables.
• Contribute to establishing and maintaining policies, procedures, and standards within the biostatistics department and in cross functional teams as appropriate.

Required Qualifications and Background

• PhD in statistics/biostatistics/related field with minimum 12 years of clinical development experience in the pharmaceutical/biotech industry is required
• 5 years of leadership and people management experience is strongly preferred
• Oncology experience is strongly preferred.
• Previous NDA/BLA/MAA experience is required.
• Ability to clearly and succinctly communicate statistical concepts to non-statisticians is required.
• Demonstrated ability to effectively collaborate with accomplished professionals within and across functions/teams.
• Solid understanding of clinical trial principles and regulatory requirements
• Knowledge of industry data standards
• Knowledge of statistical analysis software SAS and R
• Ability to plan, develop timelines, multi-task and shift priorities rapidly to meet tight deadlines.


Loxo Oncology, Inc. (Loxo) currently anticipates that the base salary for the Senior Director position level could range from between $200,500 to $294,109 and that the base salary for the Executive Director position level could range from $228,600 to $335,284 and will depend, in part, on the successful candidate’s qualifications for the role, including education and experience. This position will also be eligible for a company bonus(depending, in part, on company and individual performance).  In addition, Loxo provides a comprehensive benefit program to eligible employees, including vacation, medical, dental and vision benefits; participation in a 401(k) plan; life and accidental death and disability coverage; parental leave benefits and employee discounts for certain items.  The compensation described above is subject to change and could be higher or lower than the range described above. Further, Loxo reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion. 

Available Locations for the Role

• South San Francisco, CA
• US Based-Remote

Roles and Responsibilities of the Position

• Lead cross-functional teams that will be responsible for novel target discovery and validation.
• Supervise and mentor cell biologists and biochemists engaged in target identification and validation to think deeply and work creatively while delivering excellent scientific results and insights to the project teams and their colleagues.
• Develop and continually advance internal drug development efforts through our discovery, clinical and research programs.
• Proactively investigate new or different technologies and methods to advance our discovery projects.
• Collaborate closely with leaders across Loxo Oncology at Lilly to identify, validate and advance new targets into portfolio.

Required Qualifications and Background

• PhD in Molecular/Cellular Biology, Biochemistry, or related field.
• Minimum of 5-8 years postdoctoral and/or research experience with prior experience in target discovery/validation and cancer biology in the biotech or pharma setting.
• Deep experience in areas of cancer biology, molecular biology, biochemistry, and cancer genomics.
• Outstanding communication, writing, and presentation skills is a must.

Additional Preferred Qualifications

• Demonstrated experience supervising scientists.
• Expertise in designing and commissioning studies using cancer cell line and patient-derived xenograft models, to test oncology compounds.
• Experience with cell engineering such as knock-in and knockdown cell lines with CRISPR and/or other technologies.
• Experience working with external CROs (for PDX models, target screening, etc.).
• Experience with early clinical trial studies and the development and implementation of pharmacodynamic and patient selection biomarker assays.
• Highly organized with excellent analytical, documentation and multi-tasking skills.
• Provide strategic input to target identification and validation strategy to leadership team.
• Ability to collaborate, lead, and influence others.




Loxo Oncology, Inc. (Loxo) currently anticipates that the base salary for the Senior Principal Scientist position level could range from between $118,700 to $174,137 and will depend, in part, on the successful candidate’s qualifications for the role, including education and experience. This position also will be eligible for a company bonus(depending, in part, on company and individual performance).  In addition, Loxo provides a comprehensive benefit program to eligible employees, including vacation, medical, dental and vision benefits; participation in a 401(k) plan; life and accidental death and disability coverage; parental leave benefits and employee discounts for certain items.  The compensation described above is subject to change and could be higher or lower than the range described above. Further, Loxo reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion.

Required Qualifications and Background

• BA/BS, MS in Chemistry, Biology, Biochemistry, or related field +
• Ideal candidate will have hands-on experience with cell culture, protein sample preparation and characterization, and mass spectrometry.
• Excellent interpersonal skills with ability to communicate and interact well with colleagues, vendors, contractors, scientific advisors, and staff at all levels.
• Highly organized with excellent analytical, documentation and multi-tasking skills.
• Familiarity with Thermo Orbitrap and/or Bruker timsTOF Pro instrumentation is ideal.
• Experience in nano-liquid chromatography is a plus.
• Programming experience in R or Python is a plus.
• Expertise in other methods of enzymology or biophysical characterization and structural biology is a plus.

Roles and Responsibilities of the Position:

• Design and execute studies to select and deliver candidates
• Demonstrate laboratory expertise with biologic assays aimed at drug development (mAb, ADC and CD3 platforms)
• Perform functional mAb screening and profiling (tumor cell signaling assays, internalization, tumor cell killing assays, cytokine release assays)
• Conduct candidate evaluation in both in vitro (PK/PD, receptor occupancy, density, cytokine release), and ex vivo assays (tumor isolation, analysis of blood cells)
• Interrogate experimental conduct of third parties/vendors
• Work with the project leader and senior leader to design strategy for the development of the molecule
• Present your work to internal teams and summarize findings in preclinical reports
• Communicate results at project team meetings, be involved in the coordination and preparation of presentations
• Discuss results with technical as well as non-technical personnel
• Work in cross functional environments via extensive collaboration with other parts of the organization
• In some cases, direct leadership of a junior scientist may be required

Required Qualifications and Preferred Background:

• PhD in biological sciences with 3 or more years of experience
• BSc. in biological sciences with 8 or more years of experience
• Level of role will be consistent with experience
• Experience with ADC and/or TCE platforms highly preferred
• Extensive expertise performing in vitro and ex vivo assays
• Strong data analysis skills with attention to detail
• Ability to design comprehensive experimental plans and carry out in a timely fashion
• Deep expertise in cancer disease states (indications, mutational status, tumor cell drivers)
• Demonstrated experience in working collaboratively across various scientific disciplines to meet end goals of business
• Excellent communication and interpersonal skills
• Demonstrated ability to succeed in a fast-paced environment, working on multiple projects with constantly changing priorities and deadlines




Loxo Oncology, Inc. (Loxo) currently anticipates that the base salary for the Senior Scientist position level could range from between $89,750 to $131,672 and will depend, in part, on the successful candidate’s qualifications for the role, including education and experience. This position also will be eligible for a company bonus(depending, in part, on company and individual performance).  In addition, Loxo provides a comprehensive benefit program to eligible employees, including vacation, medical, dental and vision benefits; participation in a 401(k) plan; life and accidental death and disability coverage; parental leave benefits and employee discounts for certain items.  The compensation described above is subject to change and could be higher or lower than the range described above. Further, Loxo reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion.

Roles and Responsibilities of the Position:

• Actively engage with relevant teams to design antibody discovery workflow from immunization strategy to primary screens, and coordinate reagent generation activities to initiate antibody discovery projects
• Facilitate in identification of lead panel of antibodies from high-throughput binding screens, sequence analysis, affinity ranking, in vitro functional and potency assays, and early developability assessment
• Contribute to optimization of lead antibody sequences to improve developability and potency
• Generate antibody fragment libraries for antibody discovery and engineering, and execute HT binding screens to generate hits by phage or yeast display
• HT transfection of mammalian cells for generation of recombinant antibodies, and execute ELISA and multi-plex flow cytometry based binding screens
• Characterize affinity and in vitro potency of recombinant antibodies
• Present data and updates to management and project teams
• Follow good documentation practice including maintaining good record keeping in Electronic Notebooks
• Supervise and coach direct report(s) to execute planned activities and deliver results on time

Required Qualifications and Background:

• PhD in Biochemistry, Biomedical/Chemical Engineering, Immunology, or related field with minimum of 3+ years of post-graduate experience (preferably in industry), MS with 8+ years of research experience, BS with 10+ years of research experience in antibody or protein engineering
• Significant experience in antibody discovery and protein engineering by using single B cell cloning, hybridoma, or phage/yeast display techniques
• Strong background in molecular biology, antibody and protein expression, and biophysical characterization of recombinant antibodies and proteins
• Demonstrated experience in working collaboratively across various scientific disciplines and other parts of the organization to meet end goals
• Highly motivated individual with exceptionally good organizational skills, and attention to details
• Demonstrated ability to succeed in a fast-paced environment, working on multiple projects with constantly changing priorities and deadlines
• Excellent written and verbal communication skills
• Strong interpersonal skills 

Preferred Qualifications:

• Experience in single domain antibodies, multi-specific antibody engineering, Fc engineering, antibody drug conjugates, naïve phage or yeast display library design
• Advanced work using NGS, machine learning, and in silico prediction methods for antibody discovery and engineering
• Significant contributions to successful biologics drug discovery programs in biotech/biopharma industry

Roles and Responsibilities of the Position:

• Create, develop, and validate quantitative cellular assays, including robust screening assays to support large molecule biology and medicinal chemistry programs. Programs at early and later stages of preclinical development will be within scope. Establish processes to efficiently and effectively communicate results to project teams. 
• Assay development and cell line engineering to generate fluorescent fusions and novel signaling reporter assays.
• Participate in and lead project-based and technical team meetings to identify and solve problems, guide work towards project goals, communicate on-going work and progress, and plan forward thinking strategies. 
• Collaborate with colleagues throughout the company to ensure assays meet the program needs and results are appropriately interpreted.
• Prepare reports for internal and external purposes including regulatory submissions.
• Identify, evaluate, and manage vendors for outsourced services and studies.
• Develop and continually advance one’s knowledge base on the molecular pathways being targeted by our clinical and research programs.
• Proactively investigate novel technologies, methods, and service providers to ensure our work is being done in a scientifically sound, efficient, and reasonable way
• In the future, this position’s responsibilities may include supervision of scientists and associates. 

Required Qualifications and Preferred Background

• PhD in Molecular/Cellular Biology or Biochemistry, or related field and 3-6 years of hands-on cell biology experience in a postdoctoral and/or a biotech/pharma setting or BS/MS in Molecular/Cellular Biology or Biochemistry with 10+ years of hands-on cell biology experience in an academic and/or a biotech/pharma setting
• Extensive experience in creating, developing, and running cellular assays; engineering cell lines to express or knock-down genes of interest, interrogating cellular signal transduction pathways, and characterizing kinase activity.
• Experience with flow cytometry and general molecular biological techniques including assays for protein-protein interactions, CRISPR, q-PCR, ELISA,  Western Blot, etc.
• Demonstrated experience in working collaboratively across various scientific disciplines to meet end goals of business.
• Demonstrated ability to succeed in a fast-paced environment, working on multiple projects with constantly changing priorities and deadlines.
• Excellent interpersonal skills with ability to communicate and interact well with colleagues, vendors, contractors, scientific advisors, and staff at all levels.
• Highly organized with excellent analytical, documentation and multi-tasking skills.
• Committed to staying current with the latest scientific breakthroughs in the targeted oncology field from target identification through human clinical trials.
• Good and thoughtful listener who values collaboration.
• Enthusiastic, self-motivated and keen to improve processes and overcome inefficiencies. 
• Experience with confocal microscopy, live cell imaging (TIRF, super-resolution and high content imaging), exposure to image analysis and data management highly preferred. 

Roles and Responsibilities for the Position

• Work closely with Discovery, Pharmaceutics, Analytical, Toxicology, and Regulatory groups to facilitate rapid advancement of novel compounds
• Carry out multi-step syntheses, isolation, and purification of targeted products with limited supervision
• Conduct analysis of starting materials, reaction mixtures, intermediates and products using appropriate instrumentation
• Conduct laboratory operations in a safe manner. Maintain familiarity with Loxo Oncology at Lilly’s chemical hygiene and lab safety plans
• Reduce ideas to practice in the lab quickly by effectively employing a broad range of modern organic chemistry transformations, synthetic methods, purification and characterization techniques
• Synergize with the broader team by communicating results, sharing insights, making plans, and setting goals in an open, honest way
• Proactively identify ways in which research and manufacturing objectives can be achieved on expedited timelines while advancing multiple risk mitigation strategies in parallel
• Author technical reports and drug substance sections of CMC regulatory submissions
• Manage activities at drug substance CDMOs. Prepare RFPs and interact with contract site management and staff

Required Qualifications and Background

• BS, MS, or PhD in chemistry with a focus on synthetic organic chemistry
• Experience in small molecule process development or drug discovery in a pharmaceutical setting and a B.S. with 10+ years’ experience, M.S. with 6+ years’ experience or Ph.D. with 3+ years’ experience
• Excellent scientific knowledge of synthetic chemistry
• A proven track record of developing and improving chemistry routes for scale-up
• Experienced in the use of synthetic chemistry instrumentation: HPLC, LC-MS, NMR, and purification systems
• Expert in using common medicinal chemistry software: electronic notebook, ChemDraw, Excel; data visualization; structure viewing; literature, chemical and database searching
• Committed to staying current with the latest scientific breakthroughs in the organic chemistry field through continued reading of the literature and attendance of scientific conferences
• An excellent team player with ability to communicate synergistically with a multidisciplinary team and be a stakeholder in the progress of the project from discovery to clinical phase. Highly organized with excellent analytical, documentation, time management, and multi-tasking skills




Loxo Oncology, Inc. (Loxo) currently anticipates that the base salary for the Senior Scientist level position could range from between $89,750 to $131,672 and the Principal Scientist level position could range from between$118,700 to $174,137 and will depend, in part, on the successful candidate’s qualifications for the role, including education and experience. This position will also be eligible for a company bonus (depending, in part, on company and individual performance).  In addition, Loxo provides a comprehensive benefit program to eligible employees, including vacation, medical, dental and vision benefits; participation in a 401(k) plan; life and accidental death and disability coverage; parental leave benefits and employee discounts for certain items.  The compensation described above is subject to change and could be higher or lower than the range described above. Further, Loxo reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion.

Roles and Responsibilities of the Position:

• Keep safety as the top priority at any time, striving to maintain a strong, generative, safety culture.
• Lead characterization, purification and method development efforts for Medicinal Chemistry discovery of chiral and achiral small molecule novel therapies.
• Leveraging a broad range of techniques for solving diverse analytical problems using a broad range of analytical instrumentation such as NMR, LC/MS, SFC/MS, and flash chromatography equipment
• Collaborate cross-functionally with internal and external customers as well as with scientific and technical teams to deliver key decision-making results and to continue development of the analytical and medicinal chemistry capabilities.
• Actively engage with instrumentation and software vendors as well as academic collaborators
• Contribute to and stay abreast of journal publications and conference presentations
• Implement new techniques for the continuous development of processes and purification/characterization methodologies that will improve quality, productivity, timelines and scientific impact.
• Supervise and contribute to the scientific development of less experienced team members by organizing tutorials, vendor led training, laboratory-based coaching in new techniques, good scientific practices and laboratory safety. 
• Work effectively across sites and organizational structures to champion an unsiloed collaborative environment
• Accountable for instrument upkeep, troubleshooting, and lifecycle management

Required Qualifications and Background

• M.S. or Ph.D. in Chemistry, preferably Analytical
• 5+ years (for Ph.D.) or 10+ years (for M.S.) of relevant post-academic experience
• Demonstrated hands-on experience in analytical and preparative scale mass guided reversed phase, normal phase, and supercritical fluid chromatography.
• Hands on experience with Agilent, Waters, and Isco chromatography hardware and software.
• Theoretical understanding of various chromatographic techniques
• Strong attention to detail, highly organized, high level of learning agility, exceptional problem-solving skills, and the ability to manage several projects simultaneously
• Excellent English language oral and written communication skills, ability to engage highly effectively as team player in a multidisciplinary and international environment.


• Additional Desired Skills:
• Experience with Bruker NMR hardware and Topspin/IconNMR software
• Experience with structure elucidation using 1D and 2D NMR
• Well versed in IT enterprise infrastructure
• Solid understanding of organic or medicinal chemistry




Loxo Oncology, Inc. (Loxo) currently anticipates that the base salary for the Senior Scientist position level could range from between $89,750 to $131,672 and that the base salary for the Principal Scientist position level could range from between $103,200 to $151,423 and that the base salary for the Senior Principal Scientist position level could range from between $118,700 to $174,137 and will depend, in part, on the successful candidate’s qualifications for the role, including education and experience. This position will also be eligible for a company bonus (depending, in part, on company and individual performance).  In addition, Loxo provides a comprehensive benefit program to eligible employees, including vacation, medical, dental and vision benefits; participation in a 401(k) plan; life and accidental death and disability coverage; parental leave benefits and employee discounts for certain items.  The compensation described above is subject to change and could be higher or lower than the range described above. Further, Loxo reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion.

Roles and Responsibilities of the Position

• Perform data analysis using primarily the SAS programming language for the summary and interpretation of clinical trial data.
• Create and review CDISC, SDTM and ADaM files, SAS export files and Define.xml use for Electronic Submission from the data received in non-standard form from various sources.
• Perform data analysis, statistical analysis, generate safety and efficacy tables, listings, and graphs using Base SAS, SAS Macros, SAS/STAT, SAS/Graph, SAS/SQL and SAS/ODS.
• Develop SAS coding and table templates for preparing, processing and analyzing clinical data.

Required Qualifications and Background

• Bachelor/Master’s degree in Statistics, Life Sciences, Computer Sciences, or Mathematics with a minimum 3-5 years Pharmaceutical/Biotech programming experience.
• Experience in the analysis of complex oncology and/or hematology clinical trial data.
• Solid knowledge of SAS Programming language.
• Experience with integrated summaries (ISE/ISS) and Clinical Study Reports.
• Proven ability to work both independently and in a team setting.
• Strong well-rounded technical skills (EDC systems, MS Word, Excel, PowerPoint).
• Excellent verbal/written and interpersonal skills.
• Ability to communicate and collaborate effectively with cross-functional teams in face-to-face conversation, by telephone, and by email
• Ability to work effectively in a fast-paced environment with a positive “can-do” proactive attitude.

Available Locations for this position

• South San Francisco, CA
• US Based Remote




Loxo Oncology, Inc. (Loxo) currently anticipates that the base salary for this position level could range from between $118,700 to $174,137 and will depend, in part, on the successful candidate’s qualifications for the role, including education and experience. This position also will be eligible for a company bonus(depending, in part, on company and individual performance).  In addition, Loxo provides a comprehensive benefit program to eligible employees, including vacation, medical, dental and vision benefits; participation in a 401(k) plan; life and accidental death and disability coverage; parental leave benefits and employee discounts for certain items.  The compensation described above is subject to change and could be higher or lower than the range described above. Further, Loxo reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion.

Roles and Responsibilities of the Position

• The successful candidate will join a dynamic team and oversee computational biology efforts across multiple functions. They will be expected to lead a team, supervise and develop scientists, and help build a research strategy that leverages deep cancer biology knowledge and high-dimensional data. Success critically depends on the ability to effectively present complex analyses and results in a clear and concise manner to a diverse audience of scientists.

Required Qualifications and Background

• PhD in Bioinformatics, Biostatistics, Computational Biology, or similar area of study required. Post-doctoral training or equivalent prior work experience (3-5+ years).
• Substantial publication record and/or similar achievements.
• Demonstrated track record of strategic scientific leadership in the computational biology field with leading and developing scientists.
• Strong understanding of relevant concepts in cancer biology and molecular biology.
• Experience in large-scale data analyses involving high-throughput molecular assays such as DNA/RNA-Seq, ATAC/CHiP-Seq, single-cell technologies, etc.
• Understanding of current best-practices for high-throughput genomics/molecular data analyses and familiarity of their underlying statistical principles.
• Experience using programming languages such as R, Python, or similar for statistical analysis.

Available Locations for this role

• South South Francisco, CA
• New York City, NY
• US Based-Remote




Loxo Oncology, Inc. (Loxo) currently anticipates that the base salary for the Senior Scientist position level could range from between $89,750 to $131,672 and that the base salary for the Principal Scientist position level could range from between $103,200 to $151,423 and will depend, in part, on the successful candidate’s qualifications for the role, including education and experience. This position also will be eligible for a company bonus(depending, in part, on company and individual performance).  In addition, Loxo provides a comprehensive benefit program to eligible employees, including vacation, medical, dental and vision benefits; participation in a 401(k) plan; life and accidental death and disability coverage; parental leave benefits and employee discounts for certain items.  The compensation described above is subject to change and could be higher or lower than the range described above. Further, Loxo reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion.

Roles and Responsibilities of the Position

• Create, develop and validate quantitative mammalian cellular assays to credential novel targets.
• Establish robust high-throughput screening assays.
• Design and manage in vivo pre-clinical studies.
• Conceive and lead collaborative projects on biomarker-driven programs.
• Evaluate emerging technologies, methods, and service providers to ensure our work is being done in a scientifically sound, efficient, and reasonable way.
• Collaborate with colleagues throughout the company to ensure assays meet the program needs and results are appropriately interpreted.
• Participate and thrive in an interactive, team-oriented culture.
• Directly manage and mentor lab-based staff.

Required Qualifications and Background

• PhD in Molecular/Cellular Biology or Biochemistry, or related field.
• Minimum of 3-6 years of postdoctoral and/or hand-on research experience, preferability in biotech/pharma setting.
• Experience in relevant areas of cancer and molecular biology.
• Outstanding communication, writing, and presentation skills is a must.

Additional Preferred Qualifications

• Experience with cell engineering such as knock-in and knockdown cell lines with CRISPR and/or other technologies.
• Experience with flow cytometry and general molecular biological techniques including q-PCR, signaling experiments, assays for protein-protein interactions and Western Blot etc.
• Experience in designing and handling in vivo animal studies.
• Experience in building models (cell line, organoid or PDX) from patient samples and using them to test drug activities.
• Experience working with external CROs.
• Excellent interpersonal skills with ability to communicate and interact well with colleagues, vendors, contractors, scientific advisors, and staff at all levels and problem solving skills.
• Ability to summarize complex experiment and results for non-specialists.
• Enthusiastic, self-motivated and keen to improve processes and overcome inefficiencies.




Loxo Oncology, Inc. (Loxo) currently anticipates that the base salary for the Senior Scientist position level could range from between $89,750 to $131,672 and that the base salary for the Principal Scientist position level could range from between $103,200 to $151,423 and will depend, in part, on the successful candidate’s qualifications for the role, including education and experience. This position also will be eligible for a company bonus(depending, in part, on company and individual performance).  In addition, Loxo provides a comprehensive benefit program to eligible employees, including vacation, medical, dental and vision benefits; participation in a 401(k) plan; life and accidental death and disability coverage; parental leave benefits and employee discounts for certain items.  The compensation described above is subject to change and could be higher or lower than the range described above. Further, Loxo reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion.

Roles and Responsibilities for the Position

• Drive the project toward the next breakthrough drug candidate by designing and synthesizing new medicinal chemistry analogs that directly address project goals. 
• Optimize lead series for potency, selectivity, physiochemical properties, in vitro ADME, and PK by coupling multivariant SAR analysis with hypothesis driven medicinal chemistry design principles. Use sound scientific methods to propose hypotheses and determine next steps even with complex or ambiguous data.
• Work closely with structural biology and computational chemistry colleagues to design novel compounds and hypotheses that address key drug optimization goals.
• Reduce ideas to practice in the lab quickly by effectively employing a broad range of modern organic chemistry transformations, synthetic methods, purification and characterization techniques.
• Synergize with the broader team by communicating results, sharing insights, making plans, and setting goals in an open, honest way.
• Provide medicinal chemistry insight for new target and lead identification and evaluation initiatives in the oncology space.
• Proactively investigate new or different technologies to improve the effectiveness of the drug discovery process.
• Analyze complex data streams and conceptualize priority synthesis targets based on a holistic data approach.

Required Qualifications and Background

• BS, MS, or PhD in chemistry with a focus on synthetic organic chemistry 
• Experience in small molecule drug discovery in a biotechnology or pharmaceutical setting and a B.S. with 8+ years’ experience, M.S. with 5+ years’ experience or Ph.D. with 2+ years’ experience.
• Proven track record of success in advancing programs from leads to advanced candidates.
• Extensive experience in lead compound optimization for potency, selectivity, ADME and PK.  
• Experienced in the use of synthetic chemistry instrumentation: HPLC, LC-MS, NMR, and purification systems.
• Expert in using common medicinal chemistry software: electronic notebook, ChemDraw, Excel; data visualization; structure viewing; literature, chemical and database searching.
• Committed to staying current with the latest scientific breakthroughs in the medicinal chemistry field through continued reading of the literature and attendance of scientific conferences. 
• An excellent team player with ability to communicate synergistically with a multidisciplinary team and be accountable for the medicinal chemistry progress of the project. Highly organized with excellent analytical, documentation, time management, and multi-tasking skills.


Loxo Oncology, Inc. (Loxo) currently anticipates that the base salary for Senior Scientist level position could range from between $89,750 to $131,672 and that the base salary for Principal Scientist level position could range from between $103,200 to $151,423 but will depend, in part, on the successful candidate’s qualifications for the role, including education and experience. This position will also be eligible for a company bonus (depending, in part, on company and individual performance).  In addition, Loxo provides a comprehensive benefit program to eligible employees, including vacation, medical, dental and vision benefits; participation in a 401(k) plan; life and accidental death and disability coverage; parental leave benefits and employee discounts for certain items.  The compensation described above is subject to change and could be higher or lower than the range described above. Further, Loxo reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion.

Roles and Responsibilities for the Position

• Drive the project toward the next breakthrough drug candidate by designing and synthesizing new medicinal chemistry analogs that directly address project goals. 
• Optimize lead series for potency, selectivity, physiochemical properties, in vitro ADME, and PK by coupling multivariant SAR analysis with hypothesis driven medicinal chemistry design principles. Use sound scientific methods to propose hypotheses and determine next steps even with complex or ambiguous data.
• Work closely with structural biology and computational chemistry colleagues to design novel compounds and hypotheses that address key drug optimization goals.
• Reduce ideas to practice in the lab quickly by effectively employing a broad range of modern organic chemistry transformations, synthetic methods, purification and characterization techniques.
• Synergize with the broader team by communicating results, sharing insights, making plans, and setting goals in an open, honest way.
• Provide medicinal chemistry insight for new target and lead identification and evaluation initiatives in the oncology space.
• Proactively investigate new or different technologies to improve the effectiveness of the drug discovery process.
• Analyze complex data streams and conceptualize priority synthesis targets based on a holistic data approach.

Required Qualifications and Background

• BS, MS, or PhD in chemistry with a focus on synthetic organic chemistry 
• Experience in small molecule drug discovery in a biotechnology or pharmaceutical setting and a B.S. with 8+ years’ experience, M.S. with 5+ years’ experience or Ph.D. with 2+ years’ experience.
• Proven track record of success in advancing programs from leads to advanced candidates.
• Extensive experience in lead compound optimization for potency, selectivity, ADME and PK.  
• Experienced in the use of synthetic chemistry instrumentation: HPLC, LC-MS, NMR, and purification systems.
• Expert in using common medicinal chemistry software: electronic notebook, ChemDraw, Excel; data visualization; structure viewing; literature, chemical and database searching.
• Committed to staying current with the latest scientific breakthroughs in the medicinal chemistry field through continued reading of the literature and attendance of scientific conferences. 
• An excellent team player with ability to communicate synergistically with a multidisciplinary team and be accountable for the medicinal chemistry progress of the project. Highly organized with excellent analytical, documentation, time management, and multi-tasking skills. 


Loxo Oncology, Inc. (Loxo) currently anticipates that the base salary for Senior Scientist level position could range from between $89,750 to $131,672 and that the base salary for Principal Scientist level position could range from between $103,200 to $151,423 but will depend, in part, on the successful candidate’s qualifications for the role, including education and experience. This position will also be eligible for a company bonus (depending, in part, on company and individual performance).  In addition, Loxo provides a comprehensive benefit program to eligible employees, including vacation, medical, dental and vision benefits; participation in a 401(k) plan; life and accidental death and disability coverage; parental leave benefits and employee discounts for certain items.  The compensation described above is subject to change and could be higher or lower than the range described above. Further, Loxo reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion.

Roles and Responsibilities for the Position

• Drive and execute studies to investigate mechanisms of cancer cell growth and survival in support of the discovery and development of new cancer therapeutics.
• Establish and perform state-of-the-art cell-based and biochemical assays.
• Design and execute cross-assay validation studies.
• Identify and evaluate new technologies to advance drug discovery and development.
• Analyze and interpret data, with ability to troubleshoot assays.
• Organize and coordinate multiple projects in parallel.
• Identify, evaluate, and manage vendors for outsourced services and studies.
• Prepare and present scientific results at congresses and in peer-reviewed journals.

Required Background and Qualifications

• PhD in in biology, molecular biology, cell biology, biochemistry or related discipline, with 3+ years of lab-based experience in a biotech/pharma setting.
• Proven track record in design and development of robust assays to study protein expression, protein turnover and protein-protein and protein-small molecule interactions (e.g. MSD, HTRF, AlphaLISA, co-immunoprecipitation etc.).
• Extensive experience with aseptic mammalian cell culture and familiarity with solid tumor and/or hematologic cell lines is preferred.
• Demonstrated ability to engineer knock-in & knockout cell lines with CRISPR and/or other technologies.
• Self-organized, detail-oriented, self-directed, highly motivated with strong critical thinking and analytical skills.
• Willingness to work collaboratively and incorporate diverse perspectives into decision-making.
• Demonstrated ability to work successfully in a nimble, fast-paced, matrixed environment.


Loxo Oncology, Inc. (Loxo) currently anticipates that the base salary for the Senior Scientist position level could range from between $89,750 to $131,672 and that the base salary for the Principal Scientist position level could range from between $103,200 to $151,423 [KE1]and will depend, in part, on the successful candidate’s qualifications for the role, including education and experience. This position also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Loxo provides a comprehensive benefit program to eligible employees, including vacation, medical, dental and vision benefits; participation in a 401(k) plan; life and accidental death and disability coverage; parental leave benefits and employee discounts for certain items. The compensation described above is subject to change and could be higher or lower than the range described above. Further, Loxo reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion.

Roles and Responsibilities of the Position

• Support the recruiting process as needed including full life cycle recruitment, sourcing, screening, and scheduling of candidates.
• Utilize proven sourcing skills to identify passive candidates.
• Understand market conditions for targeted sources and work with Clinical Operations team members to best focus and execute recruitment efforts.
• Provide candidates with a best-in-class experience, maintaining contact, responsiveness and transparency throughout the process ensuring a high level of candidate engagement and positive overall experience.  

Required Qualifications and Background

• BA/BS degree required along with 3+ years recruiting experience with a proven track record of sourcing and recruiting required. Experience with Biotech or Pharmaceutical industry a strong plus.
• 3+ years experience within Clinical Operations recruitment (Clinical Trial Managers, Clinical Research Associates and Clinical Outsourcing) and/or R&D Discovery (varying levels of bench based roles within Medicinal Chemistry, Biology, Bioassay, etc.)
• Possess solid resume review and overall assessment skills to reveal candidate's technical background, business capabilities and EQ.
• Passionate, high-energy, accountable, and collaborative team player with the ability to prioritize and multi-task.
• Strong communication and interpersonal skills, with the ability to build professional relationships across all levels of the business
• Proficient in Microsoft Office suite and applications.