Career Opportunities

Role and Responsibilities for the Position

• Design and execute preclinical and absorption, metabolism, distribution, and excretion (ADME) studies to understand the pharmacokinetics (PK) of drug candidates
• Run weekly ADME assay to guide chemistry structure activity relationships (SAR)
• Participate in the management of CROs in the conduct of in vitro ADME studies
• Analyze in vitro sample utilizing LC-MS/MS
• 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 chemistry, 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
• Must have experience with pharmacokinetic modeling
 
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

• Represents Data Management for one (or more) clinical programs from a strategic planning and execution capacity in program team meetings and development strategy meetings
• Oversees the creation and execution of data management timelines used to coordinate and synchronize deliverables with the overall study timelines
• Evaluate and design DM processes for study execution, data delivery management as well as for initiatives which require cross functional collaboration
• Manage team within DM group for specific program including day to day operations, resource allocation for study, and career track development.
• Participate in study vendor FRP/bid process for all vendors as required.
• Evaluate and engage CRO/service providers for all studies and relationships as required.
• Monitors the progress of all data management activities on all studies to ensure project timelines are met
• Proactively identifies potential program and delivery issues/risks and recommends/ implements solutions
• Collaborate with Statisticians and Statistical Programmers in production of clinical trial reports and other deliverables
• Performs any and all other tasks and activities as requested by CDO

Required Qualifications and 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 12+ years’ clinical data management experience. 
• Demonstrated leadership, line management and project management skills.
• Oncology/Hematology experience strongly preferred.
• Prior experience with biostatistics and SAS programming preferred.
• Thorough and 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).
• 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.

Available locations for this role

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

Roles and Responsibilities of the Position

• Support the development and implementation of the diagnostic Medical Affairs launch strategy for assigned programs.
• Work closely and in synergy with diagnostic development teams as well as therapeutic medical affairs team.
• Communicate diagnostic and therapeutic market trends which may impact biomarker testing.
• Support companion diagnostic development timelines associated with assigned programs.
• Serve as Loxo Oncology’s scientific representative to the pathology, diagnostic and medical communities; facilitate the appropriate exchange of scientific information.
• Participate and support advisory boards and steering committees.
• Provide support through development and/or review of field based diagnostic educational and promotional materials for scientific accuracy.

Required Qualifications and Background

• MD with formal Training in Anatomic Pathology, American Board of Pathology – Anatomic Pathology eligible or certified; OR PhD with 3+ years’ pathology, in vitro diagnostic development or clinical diagnostic laboratory experience in oncology. 
• Strong knowledge of pathology laboratory clinical diagnostic testing processes, regulatory oversight, technologies and methods used.
• Ability to apply diagnostic medical experience and knowledge to business needs.
• Excellent verbal and written communications. Proficient with evaluating and reporting complex scientific and clinical data and translating them into simple messages. Quick understanding of a disease landscape. 
• Must have proven experience working in a matrixed environment and be an effective collaborator. 
• Self-directed and proactive individual with ability to thrive in a fast-paced, entrepreneurial, dynamic environment with high performing colleagues 
• Comfortable executing on multiple projects independently. 
• Ability to build strong relationships with co-workers of various backgrounds and expertise.  
• Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor 
• Excellent interpersonal skills, with the ability to gain respect and influence and to build lasting relationships with internal colleagues as well as external thought leaders within the diagnostics community.
• Ability to critically review current Dx literature, providing relevance to our products and markets.
• Planning and organizational ability as well as budget management.
• Proficient in Microsoft Office suite and applications.

Additional Preferred Qualifications

• Experience in Hematologic cancer diagnostic tests in pathology
• Experience with both anatomic and molecular pathology laboratories and test methods
• Experience and knowledge of IVD and CDx market, regulatory processes and reimbursement
• Prior direct management experience
• Experience interacting with pathologists and pathology laboratories

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

Roles and Responsibilities of the Position

• Build out GxP environment using a strong understanding of business core functions and GxP compliance needs while considering LO@LLY’s short and long-term organizational goals and initiatives.
• Provides guidance and counsel on technology, enhancements and upgrades available that drives delivery of compliance solutions consistent with business direction.
• Builds and leads a team comprised of FTEs and contractors who specialize in IT GxP systems.
• Manage technology investments to align with IT compliance architecture and roadmap in partnership with the business.
• Regularly assesses company’s GxP systems and identifies any potential Part 11 or Annex 11 gaps.
• Drives all GxP system projects throughout entire life cycle including implementation, training, deployment, adoption, change control, upgrades and retirement of all GxP systems in partnership with business.
• Initiates and manages corrective actions resulting from audit or inspection findings or other quality events pertaining to GxP deliverables or activities and determines solutions or recommendations for changes and/or improvements.
• Works cross functionally with business areas to maintain and upgrade GxP systems
• Provides input into GxP system change controls

Required Qualifications and Background

• Minimum BS/BA in Engineering, IT, or Computer Science (may consider relevant experience in lieu of education
• 8+ years of related experience within IT GxP within pharmaceutical or biotechnology setting).
• 3+ years of experience leading an IT GxP team or equivalent leadership experience within life sciences industry.
• Veeva Vault experience strongly preferred (QualityDocs, eTMF, RIM)
• Expert working knowledge of global Health Authority requirements and expectations (e.g. EU, FDA, etc.) for computerized systems in the pharmaceutical industry. 
•  Experience in a regulated pharmaceutical environment required.
• 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.
• Enthusiastic, self-motivated and keen to improve processes and overcome inefficiencies.
• Proficient in Microsoft Office suite and applications.

Available locations for this position

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

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.

Roles and Responsibilities for this position

• Manages contract writers across multiple programs. Provides additional oversight of writing activities within complex programs to ensure consistency in strategy, procedures, and messaging
• Works closely with regulatory and clinical colleagues to forecast medical writing deliverables and determine resource needs
• In collaboration with clinical and regulatory, leads the authoring and document life cycle of clinical protocols and amendments, clinical study reports (CSRs), Investigator’s Brochures (IBs), electronic Common Technical Document (eCTD) summaries and other documents for submission to the Food and Drug Administration (FDA) or other regulatory agencies
• Drives development and optimization of departmental procedures and templates
• Identifies opportunities to create efficiencies in Medical Writing procedures
• Assists in interviewing and hiring staff and contract medical writers
• Other duties as needed

Required Qualifications and Background

• BS and at least 8 years of related experience; advanced degree (e.g., MS/PhD/PharmD) preferred
• Experience in managing and/or supervising medical writers, including resource planning
• Experience in developing and optimizing document procedures and templates
• Experience in managing complex regulatory submissions, such as New Drug Applications (NDAs) or Biologics License Applications (BLAs)
• Ability to effectively collaborate with cross-functional team members (e.g., medical, clinical science, biostatistics, regulatory affairs, quality assurance, nonclinical) to meet document, departmental, and company objectives
• Extensive experience in preparation of clinical documents for regulatory submissions (e.g., clinical protocols and amendments, IBs, CSRs, Module 2 eCTD summaries)
• Ability to write and edit complex material to ensure accuracy, clarity, and effectiveness.
• Ability to work in a fast-paced dynamic environment
• Excellent time management skills and ability to manage several projects simultaneously
• Exceptional written and oral communication skills; strong attention to detail
• Knowledge of International Council for Harmonisation (ICH) guidelines for clinical and regulatory submission documents
• Expert abilities in Microsoft Office
• Familiarity with therapeutic area of oncology desirable
• Experience with Veeva Vault RIM preferred

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:

• Repair and maintain plant equipment and facilities.
• Outfit and set-up maintenance shop in new research facility.
• Assist in the start-up and commissioning of new research facility.
• Support operations in existing Boulder lab facilities with emergency response and equipment repair.
• Schedule and perform routine PM maintenance and lubrications.
• Repair, calibrate and test plant and laboratory equipment as required.
• Complete work requests in a timely and professional manner.
• Organize and maintain new facility turnover documentation and drawings.
• Schedule, coordinate and work with vendors and contractors when on-site.
• Development and maintain electronic records for calibration and maintenance work performed.
• Operate and maintain maintenance equipment and tools.
• Follow safe work practices to maintain safe working conditions.
• Clean building exteriors and grounds, assist in snow and ice removal.
• Order and inventory all necessary supplies and parts to perform required duties.
• Maintain and adhere to annual departmental budget.
• Perform routine audits for maintenance and safety.
• Perform work in confined space.
• Perform duties while using a ladder.
• Complete all required documentation.
• Execute other responsibilities and projects as required.

Required Qualifications and Preferred Background:

• Use of hand and power tools. Electrical troubleshooting and use of electrical test equipment. Perform mechanical repairs.
• Minimum of 5 years electrical and mechanical maintenance in a research environment. Instrumentation, PLC and building management system experience a plus.
• Project management experience including oversight and coordination of contractors.
• Familiarity with asset management software and experience utilizing electronic records for facilities maintenance activities.
• Familiarity with laboratory equipment and support systems including hoods, incubators, glass washers, autoclaves, refrigerators, freezers, centrifuges, material handling and waste collection.

Available Locations for this

• Boulder/Louisville, CO

Roles and Responsibilities of the Position

• Work with Subject Matter Experts to define user requirements and convert them into functional requirements.
• Modify existing and develop new custom code using industry best practices.
• Support troubleshooting, debugging, and testing of technical solutions.
• Develop queries that process and report on complex data sets.
• Develop system integrations using Restful APIs.
• Prepare custom scientific reports.
• Train end users on the use of the custom coded applications and integrations.
• Contribute to the development of Standard Operating Procedures for Scientific Systems.

Required Qualifications and Preferred Background

• BS degree required in Computer Science or Scientific/STEM related discipline.
• 3+ years programming experience in a software development environment using object-oriented programming languages and current technologies such as Python, JavaScript, and C++.
• Experience with managing large data sets and developing workflows to automate complex data updates.
• Experience with Web Services and REST APIs. 
• Experience with building and deploying web services.
• Experience with Web Servers (i.e., Apache, Nginx, IIS, etc.).
• Experience with SQL and databases such as Oracle, SQL Server, PostgreSQL, and/or MySQL.
• Demonstrated ability to learn and apply new technologies according to the changing needs of the project and organization.
• Excellent written and verbal communication skills / ability to document and communicate complex scientific concepts for a variety of audiences.


• Loxo Oncology, Inc. (Loxo) currently anticipates that the base salary for the Associate Manager level 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

Available locations for this role

• Boulder, CO
• US Based-Remote

Roles and Responsibilities of the Position

• Strategy & Planning:
•          Identify gaps in software solutions and support/develop/implement innovative workflow solutions.
•          Contribute to Scientific Computing group strategy.


• Acquisition & Deployment: 
•          Assist in the design, evaluation, and implementation of new software for science.
•          Analyze the adoption and performance of scientific software systems to give recommendations and develop strategies on how to improve the quality of scientific software support.
 
• Operational Management:
•         Facilitate communication between scientists and IT (internal or vendor related).
•        Provide administrative and desktop support of scientific software applications.
•          Develop and maintain application and training documentation.
•          Provide training to end users on the use of applications for science.
•          Identify problems, create choices and providing alternative courses of actions with software issues.
•          Employee may be required to perform additional duties as assigned.

Required Qualifications and Background

• BS/BA degree in a science discipline
• 2 years lab experience, ideally in a pharmaceutical environment
• 5+ years of experience with scientific systems


• Additional Qualifications:
•          Strong organizational skills
•          Excellent communication and presentation skills
•          Strong time management skills
•          Strong work ethic
•          Strong problem-solving skills
•          Strong team player attitude
•          Able to effectively train and mentor others


Loxo Oncology, Inc. (Loxo) currently anticipates that the base salary for the Associate Manager  level 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

Available locations for this role

• Boulder, CO
• US Based-Remote

Roles and Responsibilities of the Position

• Plans, writes, edits and finalizes manuscripts, abstracts, posters, slide presentations, and other documents to ensure appropriate evaluation and presentation of data, methodology, and interpretation aligned with the objectives of Loxo Oncology at Lilly.
• Provides support to the preclinical, medical, health-outcomes, and other relevant teams for the submission of scientific publications to target journals, congresses, and other venues.
• Develops content for and reviews publications for clarity, accuracy of content, consistency, and interpretation.
• Develops high quality deliverables.
• Gains a progressively deepening understanding of disease state and current medical issues related to the Loxo Oncology at Lilly portfolio, and serves as a technical resource on molecule and/or disease state; uses this expertise to interpret and present scientific and statistical data in publications.

Required Qualifications and Preferred Background

• Bachelor’s degree requires; advanced degree in a science field (Pharm D, PhD, DO, MD, MS or RN) strongly preferred along with 2+ years of Medical Communications/ Publications experience. Experience in the Oncology/targeted therapy drug market desired.
• Excellent verbal and written communications. Proficient with evaluating and reporting complex scientific and clinical data and translating them into simple messages. Quick understanding of a disease landscape.
• Experience with medical and scientific communication to expert and lay audiences
• Self-directed and proactive individual with ability to thrive in a fast-paced, entrepreneurial, dynamic environment with high performing colleagues.
• Comfortable executing on multiple projects independently.
• Possesses strong integrity as well as the ability to build strong relationships with co-workers of various backgrounds and expertise
• Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor
• Demonstrated flexibility as well as planning and organizational ability

Available locations for this role

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

Roles and Responsibilities of the Position

• Maintain, establish, and bank cell lines used in the lab.
• Prepare buffers, media and reagents as needed.
• Set-up and maintain laboratory equipment with some involvement in equipment evaluation, purchase, installation, testing, and IT integration. 
• Identify, evaluate, and manage vendors.
• Learn and apply new techniques to support ongoing research efforts.
• Perform cellular and biochemical assays.
• Troubleshoot experiments in a timely manner.
• Analyze, interpret, and present the data to the team and/or organization.
• Actively participate in group discussions and collaborate with colleagues throughout the organization.
• Contribute to a safe and efficient workplace. 
• Develop and continually advance one’s knowledge base on the molecular pathways being targeted by our research and clinical programs.
• Prepare reports for internal and external purposes.

Required Qualifications and Background

• BS/MS in Molecular/Cellular Biology with 1+ years of hands-on molecular and cellular biology.
• Experience in routine molecular and cellular biology techniques (i.e., bacterial transformation, Maxi/Midi/Mini DNA prep, construct generation/cloning, SDS-PAGE, Western Blotting, ELISA, PCR, qPCR, mammalian tissue culture, transfections, proliferation assays).
• Experience in developing engineering cell lines is a plus.
• Desire to work within a fast-paced, innovative, and collaborative environment.
• Excellent interpersonal skills with ability to communicate 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.


Loxo Oncology, Inc. (Loxo) currently anticipates that the base salary for the Associate Scientist level could range from between $59,000 to $86,777 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 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 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. 

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

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

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 this position could range from between $78,000 to $114,498 for a Clinical Research Associate and $89,750 to $131,672 for a Sr. Clinical Research Associate 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

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

Roles and Responsibilities for the Position

• Work closely with our multidisciplinary group on structure-based and ligand-based design and optimization of small molecule oncology drugs.
• Enable team success by employing a range of modern computational techniques including Quantitative Structural Activity Relationship (QSAR) models, homology modeling, molecular dynamics simulations, multivariate analysis, and in silico predictive models.
• Provide computational chemistry insight for new target identification and evaluation initiatives in the oncology space across a range of target and binding mode types.
• Catalyze new hit and lead discovery leaning computation insight to selection of screening collections, database mining and interpretation of results and virtual screening techniques.
• Work with on-site IT staff to administer and maintain the necessary hardware, software and other computational infrastructure to enable state of the art computational impact on oncology research programs.
• Proactively investigate new or different technologies to improve the effectiveness of the team.
• Contribute to the overall strategic thinking for the discovery organization.

Required Qualifications and Background

• Ph.D. in Chemistry or related field.
• Experience in small molecule drug discovery across a range of target types, approaches, and drug discovery strategies in a biotechnology or pharmaceutical setting is preferred.
• Possess a working understanding of medicinal chemistry, in vitro and in vivo ADME, and couple that with modeling-driven approaches that extend to aspects of lead optimization beyond potency.
• Forward thinking in terms of applying modern computational approaches to current scientific challenges. Apprised of the latest scientific breakthroughs in computational chemistry and ability to apply those techniques to good effect.
• The ideal candidate will be a key thought leader on the team with a passion for bringing creative approaches to solve challenging problems.
• Excellent interpersonal skills with ability to communicate effectively with a multidisciplinary team, the LOXO executive team, and outside collaborators. The ability to lead the team in prioritization of activities and programs.
• Ability to multi-task and shift priorities rapidly to meet tight deadlines.
• Proficient in Microsoft Office suite and applications.

Available Locations for this Role

• Boulder, CO
• San Diego, CA

Roles and Responsibilities of the Position

• Interact and collaborate with various Discovery functional teams to design and execute studies supporting all projects across the oncology portfolio
• Work collaboratively with the clinical biomarker team to perform and support retrospective and exploratory efforts for clinical programs
• Provide quality data and analyses from a variety of high throughput, high content genomic, transcriptomic, and proteomic platforms.
• Develop and implement novel molecular platforms and applications
• Work with the entire molecular characterization team to ensure all instrumentation is properly maintained and calibrated
• Provide scientific expertise on practical implementation of molecular platforms and applications across the entire Loxo organization
• Proper documentation and archiving of data and analyses.
• Work interactively with project teams and discovery informatics to interpret data and prepare formal study reports
• Communicate results via written and oral presentations as needed
• Discuss results with technical as well as non-technical personnel
• Extensive cross functional communication and collaboration with internal and external parties
• Interrogate experimental conduct of third parties/vendors

Required Qualifications and Background

• BSc. in biological sciences with 5 years of experience or MSc or PhD in biological sciences with 2-3 years of experience
• Extensive experience with multiple nucleic acid and protein expression platforms, including assay design and development
• Experience with high content, high throughput laboratory workflows with emphasis on quality and efficiency.
• Extensive working experience with Illumina next generation sequencing and knowledge of any of the following platforms: Fluidigm, Nanostring, Quanterix, Isoplexis, or Luminex.
• 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 processing, analyzing, and interpreting large biological data sets.
• Experience with Spotfire data visualization software and pathway analysis tools.
• Deep understanding of cancer disease states (indications, mutational status, tumor cell drivers)

Roles and Responsibilities of the Position:

• Work with discovery, legal, finance, and other teams to draft, negotiate and manage contracts to support drug development and related biomarker needs
• Identify and mitigate business risks throughout the contracting process

Required Qualifications and Background:

• Bachelor’s degree (MBA a plus)
• 3+ years of business development/contract negotiation experience, preferably in the Diagnostics or Biotech/ Pharmaceutical Industries
• Strong contract drafting, review and analysis skills
• Ability to communicate efficiently and effectively
• Ability to manage and meet strict deadlines, work independently, and multi-task
• Excellent attention to detail
• MS Office skills (Outlook, Word, Excel, PowerPoint)

Roles and Responsibilities of the Position:

• Work with information technology, data management, legal, finance, and other teams to help draft, negotiate and manage contracts to support business needs
• Identify and mitigate business risks throughout the contracting process

Required Qualifications and Background:

• Bachelor’s degree
• 3+ years of business development/contract negotiation experience, preferably in the Information Technology and/or Pharmaceutical Industries
• Strong contract drafting, review and analysis skills
• Alliance Management experience (or equivalent demonstration of relationship management)
• Ability to communicate efficiently and effectively
• Ability to manage and meet strict deadlines, work independently, and multi-task
• Excellent attention to detail
• MS Office skills (Outlook, Word, Excel, PowerPoint)

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)
• 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. 

Roles and Responsibilities for this 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 regulations.
• 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 of the Position

• Implement and maintain an inventory system for laboratory samples and manage sample storage on-site.
• Prepare samples for testing in biological assays and coordinate sample delivery between lab and external vendors both US and globally.
• Implement and maintain an inventory system for chemical reagents.
• Maintain complete, accurate, and organized file systems.
• Routinely and proactively order commonly used chemicals and laboratory supplies.
• Contribute to the upkeep and safety of the laboratory and assure a clean, safe, adequately supplied work area.
• Assist with stocking and organization of glassware
• Receive and unbox shipments of routine deliveries for laboratories.
• Assist with chemical inventory maintenance through registration of commercial reagents and periodic audits. 

Required Qualifications and Preferred Background

• Associates or Bachelor’s degree in the Life Sciences preferred, but will also consider high school diploma with relevant experience.
• 2+ years' direct industry experience in a lab or sample management related role.
• Understanding of safe laboratory practices.
• Proficient in Microsoft Office.
• Strong attention to detail and very organized.  
• Demonstrated ability to work well with other scientists within and across functions/teams.
• Willing to collaborate and communicate with scientists across disciplines as needed.
• Very flexible and adaptable to change.
• Enthusiastic, self-motivated and keen to improve process efficiencies. 

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

• 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

Roles and Responsibilities of the Position

• Manage automation processes to support a variety of applications across Discovery Technologies, including; application development, improvement, and optimization
• Interact and collaborate with Discovery Technology scientists to design and establish an integrated biological method and instrumentation laboratory structure.
• 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, high content genomic, transcriptomic, and proteomic platforms.
• Work with cross-functional personnel to develop and implement novel platforms and applications
• Provide automation expertise for practical implementation of molecular platforms and applications across the entire Loxo organization
• Train and support scientists on automation platforms and established SOPs, including hardware and software
• Work with the entire Molecular Characterization 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
• Extensive cross functional communication and collaboration with internal and external parties
• Interrogate experimental conduct of third parties/vendors

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
• Excellent interpersonal, written, and verbal communication skills

Additional Preferred Qualifications

• Scripting experience on Hamilton STAR liquid handling with in-depth knowledge of Venus software is preferred
• Hands on experience with multiple nucleic acid, protein, cell-based, and imaging techniques, including assay design and development is a plus

Roles and Responsibilities

• Assist implementation and maintenance of inventory and dispensing systems.
• Prepare project samples via weigh, solubilization, and/or assay plate preparation workflows.
• Troubleshoot routine hardware and software issues.
• Implement routine programming changes to laboratory robotics.
• Prepare paperwork and execute reception, shipment, and distribution of both routine and nonstandard sample shipments around the world.
• Identify and communicate opportunities to improve efficiency of various workflows.
• Maintain/Update SOPs and job aids as processes change.
• Work with project teams to assist in customer ordering and create administrative sample logistics requests to the system.
• Retain records of system/automation errors to identify improvement opportunities.
• Contribute to the upkeep and safety of the laboratory and assure a clean, safe, adequately supplied work area.
• Participate in and foster a friendly and collegial work environment.
• Assist with chemical inventory maintenance through registration of commercial reagents and periodic audits.
• Troubleshoot compound registration discrepancies and issues.
• Productively communicate with scientists to resolve workflow/shipping issues.

Required Qualifications and Background

• AS/BS degree in chemical, biological, engineering sciences or related field with 1-2 years working full time in a laboratory setting either in academia or industry.
• Understand safe laboratory practices
• Strong communication, organizational, and computer skills
• Ability to collaborate and communicate with scientists across disciplines.
• Flexible and adaptable to change.
• Self-motivated and enthusiastic about process improvement.
• Strong attention to detail and passion for delivering high quality outputs.




Loxo Oncology, Inc. (Loxo) currently anticipates that the base salary for this position could range from between $50,000 to $73,370and 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

• Represents Clinical Data Management at study team meetings with responsibility for operational execution of CDM activities.
• Executes and manages data management timelines to coordinate and synchronize deliverables with the overall study timelines.
• Generates and/or reviews/approves study documents (e.g. Data Management Plans, Case Report Forms, data transfer specifications, SAE and/or external data reconciliation plans, coding conventions, study protocols, UAT execution).
• Executes and/or distributes data management metrics, listings, and reports, as required.
• Escalate resource need to PL to meet the current study needs.
• Effectively apply knowledge of applicable internal, external and regulatory requirements/expectations (MHRA, FDA, ICH, GCP, PhRMA, Privacy, etc) to data collection and DM plans.
• Collaborate and oversee CRO/service providers on assigned studies.
• Executes/manages all data management activities on assigned studies to ensure project timelines are met.
• Continually seek means of improving processes to reduce cycle time and decrease work effort.
• Provides training on the CRF completion guidelines and EDC system at Investigator meetings and to internal or external team members, as needed.
• Proactively identifies potential study issues/risks and recommends/ implements solutions.
• Responsible for the accuracy and completeness of the clinical data collected during a clinical trial for all data deliverables.
• Provide DM support to Statisticians and Statistical Programmers in production of clinical trial reports and other deliverables.
• Work with partners to increase vendor/partner efficiencies.
• Performs any and all other tasks and activities as requested.

Required Qualifications and Background

• Bachelor’s degree in life sciences, math, computer science or related field required.
• Minimum of 6+ years’ clinical data management experience.
• A minimum of 1+ years of direct sponsor experience required.
• Demonstrated leadership and project management skills.
• Thorough and broad knowledge of data management processes, including EDC and interactive voice response system (IVRS)experience.
• Demonstrated proficiency in MS Office (Outlook, MS Word, Excel, PowerPoint).
• Experience with web-based Electronic Data Capture (EDC), clinical data management systems and industry wide thesauri, such as MedDRA and WHO Drug.
• Good working knowledge of regulatory guidelines such as GCP, 21 CFR Part 11 etc.
• Knowledge of industry standards (CDISC, SDTM, ADaM, CDASH).
• 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.
• Proven 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.
• 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.

Additional Preferred Qualifications

• 
  
• 5+ years prior oncology/hematology experience highly desirable.
• Recent Phase 3 registration study and submission experience preferred.

Available locations for this role

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

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 Preferred 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 of 5-7 years of experience in pharmaceutical services with 5 years of contract management and/or study start-up activities including contract negotiations and management
• 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. 

Roles and Responsibilities of the Position

• Collaborate with clinical trial teams and other internal stakeholders, vendors and investigational sites to support timely study start-up to meet departmental and organizational goals.
• Key vendor selection and contracting responsibilities include:
• Develop study level budget based on CRO benchmark data
• Manage the formulation of request for information (RFI) and request for proposals (RFP) for clinical services including bidding process
• Contract and budget negotiation
• Manage the development and execution of Vendor Master Agreements and Scope of Work (SOWs)
• PO generation and management
• Ongoing contract management (e.g. spend, change orders)
• Key site contracting responsibilities include:
• Develop patient/site level budget templates based on benchmark data
• Manage the development and execution of Master Clinical Trial Agreements (MCTAs) and Clinical Trial Agreements (CTAs)
• Ongoing contract management (e.g. amendments) 
• Manage the development and execution of other agreements as needed.
• When required, act as liaison between clinical service groups (SMO, CRO), legal and clinical trial teams for outsourced trials.
• Manage the negotiation efforts to resolve complex and “deal breaker” issues with external parties.
• Develop contract concepts and techniques and solve complex contractual problems that require ingenuity, innovation, and creativity.  

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 3-5 years of experience in pharmaceutical services with 2+ years of contract management and/or study start-up activities including contract negotiations and management
• 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

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

Role and Responsibilities of the Position

• Liaise across departments to proactively identify opportunities to streamline and strengthen GCP process
• 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 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.
• 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
• Strong leadership with demonstrated ability to interface with senior leaders and different levels of the organization
• Good problem solving, written and verbal communication skill
• Ability to 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
• Strong 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 an excellent written and verbal communicator.
• Detail oriented and well organized
• Good and thoughtful listener
• Critical thinker and solution oriented
• Enthusiastic, self-motivated and a self-starter

Available Locations for this role

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

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)

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

Roles and Responsibilities of the Position:

• With the Manager, work across discovery biology, translational medicine, clinical, biomarker operations, and finance/procurement to help manage initiation and timelines associated with contracts in support of drug development and related research needs
• In conjunction with the Manager, help support projects resulting from these contracts, including working with partners and academic institutions to track data and deliverables as well as financial and resource obligations

Required Qualifications and Background:

• Bachelor’s degree required along with 2+ years of project associate experience supporting project logistics and contract execution preferably in the Diagnostics or Biotech/ Pharmaceutical Industries
• Ability to communicate efficiently and effectively
• Ability to manage and meet strict deadlines, work independently, and multi-task
• Excellent attention to detail
• MS Office skills (Outlook, Word, Excel, PowerPoint)

Available locations for this role

• Boulder, CO
• Remote

Roles and Responsibilities of the Position:

• Oversees and acts as Business Operations point person for the third party management process and works closely with Quality and contracting team. Key activities include, but are not limited to: 
• Checking and communicating the status of third party vendors
• Maintaining a third party qualification list
• Facilitating qualification reviews by subject matter experts for various risk domains
• Managing the third party management IT system
• Working with internal and external business partners to facilitate timely completion of assessments and periodic reviews
• Collaborating with stakeholders for continuous process improvement improvement of processes
• Ensuring seamless communication between Loxo Oncology at Lilly and Lilly

Required Qualifications and Preferred Background:

• Bachelor's Degree is required with 3+ years experience in the Biotech/Pharmaceutical industry
• Understanding of key risk areas to be assessed (e.g., privacy, anti-corruption, etc.)
• Ability to adapt quickly to shifting needs and/or priorities
• Strong project management skills in order to manage projects at various stages and effectively multi-task
• Working knowledge of a comprehensive enterprise risk management process
• Effective communication skills
• Enjoys fast-paced, dynamic environment
• Exceptional attention to detail

Roles and Responsibilities of the Position

• Scientific roles and responsibilities:
• Design and execute studies using confocal microscopy and live cell imaging instruments
• Assay development and cell line engineering to generate fluorescent fusions and novel signaling reporter assays
• Image cell-cell interactions (i.e., CD3 redirection), cells expressing proteins of interest (i.e., cytokines, tumor associated antigens, organelles etc.), subcellular localization, trafficking, plasma membrane dynamics
• Image analysis and algorithm development, data management
• Maintain imaging facility instruments and become point of contact for any and all imaging needs for entire R&D organization
• Interrogate experimental conduct of third parties/vendors
• Facilitate experiments with in vivo pharmacology group
• Additional responsibilities:
• Communicate results at project team meetings, be involved in the coordination and preparation of presentations
• Responsible for writing reports (internal and/or regulatory)
• Discuss results with technical as well as non-technical personnel
• Work in cross functional environments via extensive collaboration with other parts of the organization
• Opportunity to directly manage junior scientists in the future

Required Qualifications and Background

• BSc. in biological sciences with 5+ years of experience or MSc or PhD in biological sciences with 2-3 years of experience
• PhD preferred
• Extensive expertise in confocal microscopy and live cell imaging, assay development, high content imaging, signaling reporter assays, TIRF and image analysis
• Experience with super resolution microscopy highly desirable
• Experience in drug discovery an asset
• Experience in automation and high throughput screening an asset
• Deep expertise in translational biology concepts, history of working with organoids and 3D assays, as well as in vivo models (e.g., mice models) considered an asset
• 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
• Demonstrated ability to succeed in a fast-paced environment, working on multiple projects with constantly changing priorities and deadlines
• Excellent written, verbal communication and interpersonal skills

Roles and Responsibilities of the Position

• Work hands-on, at the bench, in the lab, every day.
• Work closely alongside team members in the lab performing experiments involving mammalian cell culture.
• Analyze your data, organize results, prepare graphs/presentations and present them.
• Actively participate in directing the team’s research activities by designing experiments, improving procedures when they need it, and implementing novel techniques.
• Continually advance your understanding of cell biology by reading scientific literature, asking questions, attending meetings and conferences, and learning from those around you.
• Think about how your experiments are advancing the understanding of how our cancer drugs work and learn new techniques if they can improve this even further.
• Perform an experiment, analyze the results, determine what needs to happen next and do it.

Required Qualifications and Preferred Background

• BA/BS, MS or PhD required along with direct experience in an academic, research or industry setting (BA/BS with 5+ years of recent experience working with mammalian cell culture; MS with 2-5 years of recent experience working with mammalian cell culture; PhD with 1-2 years of recent experience with mammalian cell)
• Basic tissue culture techniques such cell propagation, cryo preservation, maintenance
• Prior cell culture experience with immortalized cell lines, cancer cell lines and/or primary cells
• Experience designing and performing mammalian cell assays in 96 and 384 formats
• Experience creating stable cell lines, transient transfections, viral transductions
• Prior experience with various analytical reagents such as Calcein AM, Cell Titer Glo, Alamar Blue, Annexin, PI/7AAD, and immunofluorescent antibodies
• Experience with performing qPCR, ELISA, western blot, flow cytometry, cell sorting, fluorescent microscopy, all in the context of mammalian cells
• Understanding of the techniques used to interrogate cell biology such as RNAi, CRISPR, and chemical inhibition of cellular pathways
• A high level of proficiency with many kinds of scientific software used to operate lab equipment and/or the ability to quickly master new software
• Experience and proficiency with data analysis using statistical software such as Excel, Prism, Spotfire or others  


Loxo Oncology, Inc. (Loxo) currently anticipates that the base salary for the Scientist level could range from between $78,000 to $114,498 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 of the Position:

• Develop and validate quantitative molecular and mammalian cellular assays to address mechanistic and functional questions in pre-clinical studies.
• Be responsible for target engagement/receptor occupancy and phenotypic assays to support medicinal chemistry lead optimization programs. Efficiently and effectively communicate results to the project team. 
• Identify, evaluate, and manage vendors for outsourced services and studies.
• 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.
• Participate in and present in project 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. 
• Develop and continually advance one’s knowledge base on the molecular pathways being targeted by our clinical and research programs.
• 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:

• BS/MS in Molecular/Cellular Biology or Biochemistry with 5+ hands-on molecular and cell biology assay experience in Oncology research in an academic or biotech/pharma setting.
• Experience in creating, developing, and running molecular and cellular assays; engineering cell models to modulate gene expression, interrogating cellular signal transduction pathways, and characterizing enzymatic activities. Experience with primary cell models or co-culture systems is a plus.
• Experience with general molecular biological techniques including vector engineering, cloning and mutagenesis, qRT-PCR, ELISA, MSD and Western Blotting, NGS platforms, FACS etc.
• Strong background in experimental quantitative analyses, 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, 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.
• Proficient in Microsoft Office suite and applications. 

Roles and Responsibilities

• This is a “hands-on” laboratory-based position.
• Highly motivated and actively engage in advancing drug discovery and develop the robust Tier 1 - 3 assays including biochemical (enzyme and binding), cell based (e.g., target inhibition, proliferation etc.), and tumor models (development and analysis).
• Design, execute and trouble-shoot in vitro and in vivo experiments to understand the mechanisms of action of our compounds (or benchmarks) and characterize the target biology using biochemical, molecular, and cellular assays.
• Perform comprehensive data analysis and communicate the experimental findings to the project team.
• Work collaboratively and incorporate diverse perspectives into decision-making, and work successfully in a nimble, fast-paced matrixed environment.

Required Qualifications and Background

• BS/MS in oncology, biology, biochemistry, or related fields with 3+ year of hands-on bench experience, preferably in an industry setting. 

Additional Preferences

• Ability to leverage multiple assay platforms to measure target engagement, pathway modulation and cell activity in response to compounds treatment.
• Strong understanding of oncology and signaling pathways.
• Hands-on experience in cell viability, proliferation, and apoptosis assays; lentivirus production, titration, and transduction; and cell culture expertise (cell lines and primary cells) including clonal cell isolation techniques. 
• Demonstrated experience in developing cell-based assay to monitor protein levels and modifications including the following methods: ELISA, In-Cell Westerns, Mesoscale, HTRF, AlphaScreen, MALDI-TOF MS.
• Experience with the biochemical and kinetic-based assay technologies (e.g. FP, TR-FRET, AlphaScreen, Luminescence) and the multiplexed antibody-based detection methods (e.g. Luminex, Mesoscale).
• Tumor biology including cell line xenograft and/or PDX models in oncology setting, and tumor and/or tissue sample handling and processing for biomarker analysis.
• Experience with developing multi-channel flow cytometry-based screening assays including sample preparation, staining, operating flow cytometers, and analyzing flow.
• Ability to perform quantitative data analysis, curve fitting, statistics etc.
• Experience with laboratory instrumentation and automation.
• Ability to multi-task and shift priorities rapidly to meet tight deadlines.
• Continual learner and possesses a can-do attitude.
• Excellent oral and written communication skills including experimental documentation.
• Possess personal accountability for excellent and timely results.
• Highly organized with exceptional attention to detail.
• Demonstrating the ability and willingness to work effectively in a highly collaborative research environment.
• Proficient in Microsoft Office suite and applications.
• Metabolite analysis in cells and tumors.
• Experience with small molecule compound testing.
• Proficient in CRISPR, shRNA and/or siRNA gene regulation.
• Organoid or 3D culture method development.
• Colony formation assay experience.
• High content cellular imaging skills.
• Expertise in running high-throughput and automated cancer cell proliferation panels.
• Experience in confocal microscopy.
• Gene expression profiling of tumor samples.
• Experience in the generation and analysis of mouse cancer models, tumor implantation techniques and dosing, tumor measurement, health monitoring, and data collection and analysis.
• Ex vivo experience analyzing biomarkers (examples include flow cytometry, IHC, ELISA, RT-PCR, Westerns, Luminex).
• Experience with bioluminescent imaging studies.
• Understanding of PK, PD, and PK/PD relationship.

Roles and Responsibilities of the Position

• Provide recombinant protein expression support within a structural biology & enzymology setting.
• Execute projects in an efficient manner, working within 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.
• Ideal candidate will have with 5+ 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, insect cell, mammalian) for recombinant protein expression. Hands-on experience of a variety of insect cell cells (SF9, SF21, T.ni/Hi5) from culture, transfection and characterization is desirable and/or experience utilizing mammalian cell lines such as CHO, Expi, HEK etc.
• Experience with small scale analysis of biomass, particularly regarding soluble protein expression.
• Hands-on experience of protein purification techniques such as IMAC, SEC, IEX are desirable as is experience with the Phynexus and Akta FPLC is 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.  

Roles and Responsibilities of the Position

• Provide recombinant protein purification support within a structural biology & enzymology setting.
• Execute projects in an efficient manner, working within 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.
• 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.
• Ideal candidate will have with 5+ 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.
• Expertise with FPLC protein purification techniques such as IMAC, SEC, IEX, HIC is required, ideally utilizing the Akta FPLC systems.
• Expertise with protein characterization techniques such as Mass Spectrometry (Orbitrap, QTOF, hybrid traps) and Thermal Denaturation assays such as differential scanning fluorimetry (DSF) is highly desirable.
• Familiarity with biophysical techniques such as SPR, HDX, DLS, ITC, binding assays, enzyme kinetic assays is desirable.
• Experience with a variety of protein expression systems (E.coli, BV, mammalian, yeast) 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.
• Sample preparation specifically for X-ray crystallography or Cryo-EM is desirable.
• Highly organized with excellent analytical, documentation and multi-tasking skills.
• Experience across the gene-to-structure pipeline is a plus.
• A learners mindset

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 of the Position

• Deliver cryo-EM protein: ligand structures to drug discovery teams utilizing their expertise in the cryo-EM process from construct design through structure refinement and analysis.
• Coordinate cryo-EM data collection on multiple protein targets.
• Optimize sample vitrification conditions and collect high resolution data.
• Collect and analyze cryo-EM data including, contrast transfer function estimation and motion correction, particle picking through neural network algorithms, 2D classification, 3D reconstructions through particle polishing, masked local refinementand 3D variability.
• Structure determination, atomic model building and validation.
• Train scientists in all aspects of the cryo-EM workflow: cryo-EM sample handling and preparation, data acquisition and data processing using various state-of-the-art software for 3D reconstructions, atomic model building and validation.
• Provide scientific expertise to cross-functional project teams on recent advances and explore the feasibility of experiment proposals.

Required Qualifications and Background

• Ph.D. or equivalent in structural biology, biophysics, or a related field with postdoctoral/industrial experience in structural biology and 2+ years of documented experience in Single particle cryo-EM.
• Experience with cryo-EM sample preparation protocols including protein sample purification and analysis.
• Experience with operation of Cryo-EM microscopes and automatic data collection.
• Experience with cryo-EM software packages for collecting and processing data such as Cryo-SPARC, RELION, EMAN2, cis-TEM,
• Experience with software for model building and refinement such as Phenix, CCPEN, Flex-EM, Isolde, ChimeraX, Rosetta etc.
• Experience with Micro-ED, protein crystallography, and protein:ligand mechanistic studies is desired.
• A true team player with a track record of successful collaborations.

Role and Responsibilities for the position

• Drive in vitro and in vivo studies from design to completion to evaluate efficacy of novel therapeutics.
• Execute in vivo experiments to evaluate the pharmacokinetic and pharmacodynamic effects of compounds.
• Establish and manage relationships with external CROs, internal research groups, and academic collaborators to drive research.
• Organize and coordinate multiple projects in parallel.
• Analyze and interpret experimental data with the ability to troubleshoot assays.
• Prepare and present scientific results at internal and external meetings.

Required Qualification and Background

• PhD in a biological discipline with a minimum of 2 years of postdoctoral research experience. Experience in a pharmaceutical/biotech setting preferred.
• Research experience in disease biology using in vitro and in vivo models, preferably in oncology.
• Experience using CRISPR, shRNA and/or siRNA to determine mechanism of action.
• Hands-on in vivo experience, including animal handling, performing routine dosing (IV, PO), necropsy, collection of blood and tissues.
• Expertise in rodent models of human cancer including GEMMs, CDX, PDX and syngeneic models is highly desirable.
• Experience in molecular and cell biology techniques and assays including ELISA, immunoblotting, MSD, qPCR, IHC/ICC and functional assays to characterize biomarkers in cells and tissues.
• 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.
• Excellent written and verbal communication skills required.

Role and Responsibilities for 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.
• Computational skills are highly desirable.
• Strong communication & interpersonal skills are essential for success in this collaborative role.

Required Qualifications and Background

• PhD preferred, or a BA/BS or MS in Chemistry, Biology, Biochemistry, or related field +
• Ideal candidate will have hands-on experience with protein characterization and cell culture.
• 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.
• Expertise in other methods of enzymology or biophysical characterization and structural biology is a plus

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 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

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

• New York City, NY

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 6+ years’ of experience in Phase 1-3 trial management.
• Oncology and/or Hematology experience strongly preferred;
• For oncology studies: Oncology and/or Hematology experience preferred; for clinical pharmacology studies: 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.

Available locations for this role:

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

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

• 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.

Roles and Responsibilities of the Position

• Facilitate in building a team of scientists and associates at various levels within Loxo Oncology Biologics
• Lead a diverse group encompassing analytical and mass-spectrometry based characterization of large molecule biologics for oncology
• Responsible for designing, overseeing, and executing key experiments for analytical and mass-spectrometry based characterization of these large molecules from early discovery to early development stage
• Interact and collaborate with other teams across the company to provide analytical and mass-spec solutions; analyze, collate, and disseminate data to teams in a timely manner
• Participate and present periodic updates and reports to senior management to significantly influence strategic research decisions and operations
• Participate in long-term strategies for creation of innovative solutions and intellectual property for securing FTO for Loxo
• Liaise with CROs and vendors for contract work and evaluations

Required Qualifications and Background

• Ph.D. in life or analytical sciences or equivalent fields with at least 15 years of relevant job experience in the biopharma industry with good understanding of drug development process with emphasis on antibody-drug conjugates.

Additional Preferred Qualifications

• Demonstrated leadership skills in leading a team by providing clear direction, setting expectations, and mentoring scientists
• Demonstrated proven expertise in protein mass-spectrometry for antibodies including LC-MS intact protein analysis, peptide mapping, conjugate analysis, PTMs, de-novo sequencing, and chemical modifications
• Experienced in small molecule and protein mass-spectrometry of antibody drug-conjugates (ADC) for characterization of conjugation site analysis, positional isomers, free drug, drug stability, and metabolite analysis
• Experienced in analytical characterization of large molecules and conjugates using SEC/HIC, U/HPLC, cIEF, CE and cLIF
• Lead in setting up studies for assessment of antibodies and ADCs for developability/CMC and assist in writing of technical reports, SOPs, and regulatory documents for IND
• Prior experience in participation of team efforts for antibody lead panel generation, lead optimization, and IND enabling studies
• Hands-on experience on data analysis of mass-spec data, informatics, and tools such as Graphpad Prism,
• Demonstrated can-do attitude and brings innovative ideas in challenging projects set up in a collaborative, cross-functional organization
• Excellent communication skills and with strong organizational abilities

Roles and Responsibilities of the Position

• Establish regulatory progression pathways for discovery and clinical candidates.
• Set strategy, guide, author, and review regulatory documents.
• Create and evaluate mechanistic and predictive toxicology studies, including DMPK considerations, designed to assess hypotheses for and evaluate mechanisms of toxicity related to physiological or biochemical functions. advise
• Evaluate safety assessment and toxicology data to support nomination of drug candidates for further development.
• Communicate results clearly and concisely in both oral and written reports and presentations.
• Perform in depth pathway/network analysis on data derived from toxicology and other studies and disseminate results to the wider toxicology community (internally and externally).
• Evaluate new targets for potential toxicological liabilities.
• Closely interact with scientists in other functional areas.

Required Qualifications and Background

• Ph.D. in toxicology required, along with 10+ years’ experience as a toxicologist within the biopharmaceutical industry. Board certification in Toxicology strongly preferred.
• Previous small molecule oncology therapeutic product development experience in a pharmaceutical or biotechnology company is preferred.
• Familiarity with GLP regulations and regulatory guidelines for the testing of biopharmaceutical products and experience with compilation of toxicology information into various regulatory submission documents is desirable. 
• Strong experience in writing and submitting regulatory documents for oncology indications and responding to regulatory agency questions.
• 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.
• 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.

Roles and Responsibilities of the Position

• Responsible for supporting all aspects of regulatory submissions relevant to assigned projects or programs.
• Preparation and submission of routine regulatory documents such as Annual Reports/DSURs, Investigator Packages, and SUSARs
• Contribute to the development of briefing packages for meetings with FDA and other global health authorities.
• Support the implementation of regulatory strategy for assigned projects and programs for projects in all stages of development (IND through NDA/BLA approval and commercialization).
• Ensure completion of documents and other assigned tasks within established timelines and with high quality – in terms of scientific content, organization, clarity, accuracy, format, consistency and adherence to regulatory guidelines, styles and processes.
• Provide review of responses and other documents intended for submission to FDA and other global health authorities as needed.
• Prepare and compile effective presentations for external and internal audiences as needed.

Required Qualifications and Background

• BS degree required; advanced degree (PharmD, PhD, Master’s) preferred. Strong scientific or research background, with a focus in pharmacy, chemistry, or biology, preferred.
• Minimum 3 years’ experience within the biotech or pharmaceutical industry within the drug development space for candidates with a BS degree.  No minimum experience required for candidates with advanced degrees.
• Experience and knowledge in the preparation of regulatory submissions and supportive amendments or supplements preferred.
• Experience in interpretation and application of US regulations and guidelines preferred.
• High level of motivation and proactiveness required to engage in both in-person and remote team members. 
• Preference given to those with a strong self-motivation to rapidly learn and accelerate the work to meet challenging timelines.
• Ability to work both independently and within project teams to attain group goals.
• Demonstrate strong organizational skills, including the ability to prioritize tasks.
• Excellent oral and written communication skills, with a strong attention to detail.

Available Locations for the Position

• South SF, CA
• Stamford, CT

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

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

Roles and Responsibilities of the Position

• Keep safety as the top priority at any time, striving to maintain a strong, generative, safety culture.
• Lead liquid state NMR and Mass Spectrometry based small molecule structure elucidation and verification efforts to support the Discovery Medicinal Chemistry organization
• Design and implement a variety of 1D and nD NMR experiments for quantitation, structure elucidation, and conformational studies
• Operate and maintain several open access NMR instruments and high-resolution MS instrumentation.
• Actively engage with instrumentation and software vendors as well as academic collaborators to enable innovative analytical solutions.
• Contribute to and stay abreast of journal publications and conference presentations.
• Implement new techniques for the continuous development of processes and NMR and MS methodologies that will improve quality, productivity, timelines and scientific impact.
• 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
• 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 un-siloed collaborative environment 

Required Qualifications and Preferred 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 with NMR techniques, hardware and software
• Deep theoretical understanding of NMR
• Experience with Bruker NMR hardware and Topspin/IconNMR software
• Demonstrated hands-on experience with high resolution mass spectrometry
• 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 Preferred Skills

• Experience with 3rd party software such as Mestre and ACD
• Experience with new NMR pulse sequence development/implementation and writing/implementing python scripts
• Well versed in IT enterprise infrastructure
• Well versed in other analytical techniques, especially chromatography and physical/informational automation
• Solid understanding of organic or medicinal chemistry
• Natural products structure elucidation experience is a plus


Loxo Oncology, Inc. (Loxo) currently anticipates that the base salary for the Senior Scientist could range from between $89,750 and $131,672, that the base salary for the Principal Scientist could range from between $103,200 and $151,423, and that the base salary for the Senior Principal Scientist could range from between $118,700 and $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 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 Remot

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

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.

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. 

Roles and Responsibilities for the Position

• Keep safety as the top priority at any time, striving to maintain a strong, generative, safety culture.
• Contribute to 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, GC/MS, SFC/MS, flash chromatography equipment
• Hands on maintenance/upkeep of laboratory instrumentation
• 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.
• Contribute to the continuous development of processes and purification/characterization methodologies that will improve the quality, productivity, timelines and scientific impact.
• When necessary, 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. 
• As appropriate, develop Standard Operating Procedures, instrument maintenance and testing plans.

Required Qualifications and Background

• B.S./M.S. in Chemistry with 3+ years of relevant experience
• Demonstrated hands-on experience with chromatographic purification techniques
• Demonstrated hands-on experience acquiring and interpreting data from various analytical instruments such as LC/MS, GC/MS, and NMR
• Excellent English language oral and written communication skills, ability to engage highly effectively as team player
• Strong attention to detail, highly organized, high level of learning agility, exceptional problem-solving skills, and the ability to manage several projects simultaneously

Additional Desired Skills:

• Experience with analytical and preparative scale SFC instrumentation
• Experience with Bruker NMR hardware and Topspin/IconNMR software
• Experience with structure elucidation using 1D and 2D NMR

• Loxo Oncology, Inc. (Loxo) currently anticipates that the base salary for the Senior Research Associate could range from between $58,000 and $85,109 and the base salary for the Associate Scientist could range between $59,000 and $86,577  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 of the Position:

• Using surface plasmon resonance (SPR) and Biolayer Interferometry (BLI) to characterize the kinetics and affinity of antibody/antigen interactions
• Using SPR and/or BLI for epitope binning and receptor/ligand blocking studies
• Characterizing protein stability, purity and quality using a variety of techniques, such as dynamic light scattering (DLS), static light scattering (SLS), capillary isoelectric focusing (cIEF), size exclusion chromatography (SEC), ion exchange chromatography (IEX), CE-SDS, and SDS-PAGE.
• Independently performing assay development, troubleshooting and optimization to ensure reliable & accurate results.
• Clearly documenting experiments and results in electronic lab notebook entries
• Presenting and discussing results in multidisciplinary group meetings

Required Qualifications and Background:

• Ph.D. in life or analytical sciences or equivalent fields, M.S. in these fields with 2+ years of relevant job experience in the biopharma industry or B.S. in these fields with 5+ years of relevant job experience in the biopharma industry. Previous experience with therapeutic antibodies, antibody conjugates, bi and multi-specific molecules, and other modalities is preferred.
• Experience in characterization of biomolecular interactions using various assays and techniques such as ELISA, SPR (e.g. Biacore), BLI (e.g. Fortbio Octet), and other relevant platforms for characterization of high/low affinities, concentrations, cross-blocking activities, and other product defining characteristics
• Demonstrated knowledge and experience with biophysical techniques and platforms for characterization of physical, chemical, and conformational stabilities of biologics
• Hands-on experience with data analysis and visualization software tools such as Graphpad Prism, Spotfire etc.
• Demonstrated can-do attitude desire to work in a collaborative, cross-functional organization
• Experience with protein purification and formulation is preferred
• Excellent communication skills and strong organizational abilities