Career Opportunities

Roles and Responsibilities of the Position

• Lead Biologics project management group ensuring leadership, coaching, and mentoring (with direct oversight and hands on implementation) adapted to Loxo’s dynamic, start-up, discovery-tuned environment.
• Liaise between Biologics’ leadership management and cross functional project teams ensuring continuous alignment between program strategies and implementation of the strategies.
• Direct oversight in managing project management resources and accountable for ensuring that the existing project management structure (PMO framework) is implemented and extended to support the needs for the expanded program portfolio.
• Actively involved (hands on leadership with project managers) in project initiation, planning, execution, monitoring, and closing of all programs in the portfolio.
• Actively manage Biologics’ portfolio budget
• Proficient in managing resource allocation and application of risk management across the portfolio.
• Actively manage communication plans for all programs outlining clearly determined escalation path aligning with stakeholder management requirements. Maintain transparency with strategic partners and stakeholders in all communications.
• Actively facilitate in creating progress reports, PowerPoint slide presentations, and present them to Biologics’ and extended Loxo leadership for Biologics programs.
• Provide support in due diligence efforts for in-license and out-license evaluation.
• Lead in overseeing and actively engage in day-to-day operational activities involving with other functional groups (Business Operations – procurement, finance, accounting etc.). Ensure all external collaborations (suppliers, CRO’s and vendors) and alliances with strategic partners within and outside the company are appropriately managed.
• Coordinate with CMC and other relevant functional groups to successfully transition programs from preclinical to clinical stage.
• Adaptive to change in priorities and able to drive program outcomes ensuring re-alignment with program strategies in changing landscape.
• Proficient in strategic and adaptive communications. Able to effectively communicate and navigate through technical and non-technical audiences across cross-functional departments within the company and external collaborators.
• Adept in seeing high-level overview and granular details of a program and able to steer between both sides.
• Demonstrate “team spirit” through day to day actions and actively contributes to team development
• Foster “growth mindset” and “can do” attitude
• Demonstrate exceptional problem-solving skills      

Required Qualifications and Preferred Background

• 8+ years of project management experience in leading project management roles in Biotech and pharmaceutical research and discovery set up
• Bachelor’s degree in relevant scientific field (e.g., Biology) required; advanced degree strongly preferred
• PMP certification required

Additional Preferences

• Proven success in building, managing, and mentoring cross-functional teams in a dynamic environment from ground up to meet end goals of business
• Possess sound knowledge in Biologics drug discovery and development process starting with target identification, early-stage antibody discovery through preclinical stage, and apply them effectively in managing discovery research projects.
• Demonstrate business acumen and demonstrate excellence in facilitating key strategic decisions in support of broader business goals and objectives
• Navigate clearly between strategies and day-today operations.
• Manage and balance both laterally and horizontally
• Proven success in managing suppliers, vendors, and strategic alliances.
• Excellent verbal/written communication and interpersonal skills
• Expert in 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
• Seasoned facilitator aligning people of diverse mindset to achieve common goals and objectives
• Mentor and coach Project Managers and team members to function optimally in a dynamic, cross-functional environment while maintaining alignment with strategic assets
• Excellent organizational skills adaptive to program requirements
• Proficient in identifying gaps in the existing processes and facilitate in creating framework and processes (including applying tools e.g., MS Office suite, MS Project. SmartSheet) aligning with the needs for effective project management

Additional Locations for this role

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


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

Roles and Responsibilities of the Position

• Evaluate new targets for potential toxicological liabilities.
• Create novel experimental designs for mechanistic toxicology studies, including DMPK considerations, designed to assess hypotheses for and evaluate mechanisms of toxicity related to physiological or biochemical functions.
• Support predictive toxicology experimental efforts within Discovery (e.g., in vitro cell-culture based, animal models of disease) analyze safety-related data and use it to make decisions.
• Develop early safety assessment and ensure appropriate toxicology studies and liability screens are performed 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).
• 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 large molecule development experience and/or 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. 
• 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.


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

Roles and Responsibilities of the Position:

• Collaborate with the relevant functional groups, legal, and finance teams to draft, negotiate and manage contracts to support Toxicology, Biomarkers, Human Resources, IT, Hospitality/T&E, and consulting needs
• Identify and mitigate business risks throughout the contracting process
• Manage other contracts experts and address their questions/concerns as they arise

Required Qualifications and Background:

• Bachelor’s degree; MBA preferred
• Scientific background preferred
• 10+ years of business development/contract negotiation experience, preferably in a BioPharma or Diagnostics setting
• Strong contract drafting, review and analysis skills across a variety of contracts, including Master Service Agreements, Statements of Work, and Consulting Agreements
• Ability to communicate and negotiate efficiently and effectively
• Ability to manage and meet strict deadlines, work independently, and multi-task
• Excellent attention to detail
• Collaborative mindset
• MS Office skills (Outlook, Word, Excel, PowerPoint)

Available locations for this role:

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

Roles and Responsibilities of the Position:

• Manage the outsourced EDC programming function and the support model for all active EDC databases, by providing consistent team direction, guidance, and monitoring of quality of work through robust vendor governance, audits, quality plans, and oversight of key performance metrics
• Manage the personnel resources, workload allocation, career development and compensation for all FTEs within their group.  Planning horizon is typically up to 12 months
• Develop the infrastructure, people, standard processes, and tools to build out the EDC programming capability within the department, in coordination with CDM leadership
• Develop the outsourcing strategy, resources, and standard processes to manage the clinical programming function for the department, in coordination with CDM leadership
• Develop partnerships and collaborations with key cross functional teams, such as Information Technology, Quality Assurance, Clinical Operations, Biostatistics and Statistical Programming
• Support and lead the development of standards implementation activities for both internal data management as well as cross functional projects.  Provide oversight for the maintenance and governance of the standards library
• Support the evaluation and selection of future CDM systems infrastructure and solutions, including programming and data visualization tools, eSAE, and clinical data repository/data lake solutions to support standardized data review and data cleaning goals. Planning horizon is typically 6-36 months
• Sponsor the evaluation, prioritization and execution of department projects and initiatives related to CDMS and Clinical Programming.
• Evaluate and support the development of CDM processes for study start up, execution, and data delivery. Reviews and approves all new processes and templates impacting their area/s of oversight
• Represents Data Management from a technology planning and execution capacity in development and/or strategic meetings
• Sustain and grow industry knowledge with regards to innovations in trial execution best practices, database technology, and information delivery to key stakeholders (analytics, dashboards, metrics, etc.)
• Evaluate innovative technologies, as appropriate
• Perform all other tasks or activities as requested

Required Qualifications and Preferred Background:

• Bachelor’s degree in life sciences, math, computer science or related field required. Master’s degree in life sciences, math, computer science or related field preferred.
• Minimum of 10 years’ clinical data management/clinical programming experience and at least 6 years of managerial experience  supervising direct reports in the biotech, pharmaceutical, medical device or CRO industry, in all phases of drug development.
• 8 years of experience leading CDM technical project teams is also acceptable in lieu of 6 years of direct report management.
• Prior experience implementing EDC system infrastructure, as well as developing the teams, operating procedures, and continuous process improvement mechanisms to support the system.
• Demonstrated leadership and project management skills.
• Working knowledge of common industry data programming software and applications (e.g. SAS, BI / analytics tools, EDC Programming) required.
• Oncology experience required.
• Thorough and broad knowledge of data management processes, including EDC and interactive voice response system (IxRS).
• Knowledge of regulatory guidelines such as GCP, 21 CFR Part 11 etc.
• Knowledge of data standards (CDISC, CDASH, SDTM) in the clinical environment.
• Must have excellent verbal and written 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 demanding environment.
• Demonstrated ability to stay abreast of trends and the latest information in the profession.


Loxo Oncology, Inc. (Loxo) currently anticipates that the base salary for the Associate Director/Director level position could range from between $135,300 to $198,600 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 for this Position

• Responsible for developing and implementing the regulatory strategy for assigned projects and programs for projects in all stages of development (IND through NDA/BLA approval)
• Applies global regulatory knowledge governing responsible products to contribute to the overall development strategy
• Provide regulatory leadership & guidance to project teams
• Lead and support FDA meetings; develops briefing packages for meetings with FDA and other global health authorities
• Responsible for coordinating all aspects of regulatory submissions relevant to assigned projects or programs
• Develop response strategies and submissions to regulators
• Develop regulatory submission documents. Manage or delegate the management of the 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
• Develop strategies and drafts and/or review responses and other documents intended for submission to FDA and other global health authorities
• Identify and assess regulatory risks for assigned projects or programs
• Prepare and deliver effective presentations for internal audiences
• Monitor newly published FDA guidelines and international guidance documents in the context of new and ongoing development programs
• Primary point of contact to regulatory agencies relevant to assigned projects or programs, as appropriate

Required Qualifications and Background

• 8+ years pharmaceutical/drug development experience and 6+ years in Regulatory Affairs.  Advanced degree in a scientific discipline preferred.
• Experience in successful submission of INDs/CTAs required, NDA/BLA/MAA submission experience preferred.
• Proven experience navigating successful submissions in the oncology space is preferred
• Strong scientific foundation, including a good understanding of oncology, is preferred.
• Knowledge and understanding of US regulatory requirements
• Self-motivated in accelerating work to meet challenging timelines
• Ability to work both independently with minimal direction and within project teams, committees, corporate partners, etc. to attain group goals
• Demonstrate excellent communication skills
• Ability to represent the group in project teams
• Demonstrate strong organizational skills, including the ability to prioritize tasks
• Experience in interfacing with relevant regulatory authorities
• Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements
• Experience in interpretation and application of regulations, guidelines, policy statements, etc.

Available Locations for This Role

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


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

Roles and Responsibilities of the Position:

• Conducts Audits for which LO@LLY is responsible (e.g.qualification and internal)
• Key activities include, but are not limited to: 
• o   Plan, execute, and monitor LO@LLY qualification audits
• o   Plan and execute internal audits
• o   Support development of an audit schedule
• o   Support audits conducted of LO@LLY by outside auditors
• o   Partner with LO@LLY functional areas to support Health Authority audits
• Provide input in Quality Management review, which includes metric generation and data analysis.
• Support process improvement projects
• Perform other duties as assigned. 

Required Qualifications and Background:

• Bachelor's Degree or 5-7 relevant experience in the Biotech/Pharmaceutical industry
• Working knowledge of Microsoft 365 suite, Veeva, etc.
• Comprehensive working knowledge of GCPs, GLPs, GMPs, or CAP and CLIA requirements.
• Strong working knowledge of global regulations and guidelines (e.g., FDA/EU and ICH) for early phase pharmaceutical development in both clinical trials execution, clinical/biomarker laboratories and nonclinical/preclinical work.      
• 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
• Able to interface well with all levels of personnel.
• Capacity to produce high quality results across multiple projects and demands, through effective prioritization, while working under short deadlines associated with a fast-paced dynamic scientific environment.
• Excellent communications skills, both written and verbal.
• Excellent teamwork, interpersonal skills and negotiation skills, both internally and externally.
• Strategic thinker, open-minded and flexible to adopting new ideas.
• Motivated, committed and self-managed.
• Willingness to work in a dynamic and changing corporate environment
• Requires a flexible work schedule to accommodate program priorities and international activities as needed.
• Exceptional attention to detail

Roles and Responsibilities of the Position:

• Work with discovery, translational medicine, biologics, biomarker, toxicology, and/or CMC teams as well as legal and finance teams to help draft, negotiate and manage contracts and related amendments in support of drug development and related discovery pipeline needs
• Identify and mitigate business risks throughout the contracting process
• Help manage projects resulting from these contracts, including working with project managers and finance to track results as well as financial and resource obligations

Required Qualifications and Background:

• Bachelor’s Degree in Science related discipline required
• 3+years of business development/vendor management experience, preferably in a biotechnology or pharmaceutical setting
• Ability to communicate efficiently and effectively
• Ability to manage and meet strict deadlines, work independently, and multi-task
• Excellent attention to detail and critical thinking skills

Roles and Responsibilities for the Position

• Lead Biomolecular NMR efforts to support the Discovery Organization in lead generation, hit validation, hit to lead and lead optimization phase of projects.
• Design and implement a variety of 1D and nD NMR experiments for quantitation, characterization of binding dynamics, conformation, and structure of ligand-biomolecule interactions
• Use multinuclear protein and ligand observed NMR methods for Fragment-Based Drug Discovery (FBDD) efforts
• Use well-manicured results from NMR spectroscopy to quickly provide go/no-go decision making to project teams
• Work seamlessly with the structural biology organization and medicinal chemistry teams to understand and rapidly address project needs
• Operate and maintain a 600 MHz cryo-probe equipped NMR spectrometer
• 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 methodologies that will improve quality, productivity, timelines and scientific impact.
• Collaborate cross-functionally with internal and external teams to deliver key decision-making results and to continue development of the analytical and medicinal chemistry capabilities
• Contribute to the scientific development of 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 collaborative environment
• Keep safety as the top priority at any time, striving to maintain a strong, generative, safety culture.

Required Qualifications and Background

• M.S. or Ph.D. in Chemistry (preferably Analytical), Biophysics, Biochemistry or other related field
• 3+ years (for Ph.D.) or 7+ years (for M.S.) of relevant post-academic experience
• Demonstrated hands-on experience with 1D-nD NMR experiments in the Biophysical NMR area with a strong publication record
• Deep theoretical understanding of 1D-nD NMR spectroscopy
• Experience with Bruker NMR hardware and software
• 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 3rd party software such as NMRPipe, Mestre and ACD
• Experience with new NMR pulse sequence development/implementation and writing/implementing python scripts
• Well versed in IT enterprise infrastructure
• Solid understanding of medicinal chemistry

Roles and Responsibilities of the Position

• Assists in providing day to day support of overseeing the review and reconciliation of safety and efficacy laboratory data including but not limited to the following tasks.
• Partners with CRO for tracking and reporting on laboratory data completeness and cleanliness.
• Assists with the development of study-level laboratory plan and associated listing specifications.
• Perform and document UAT activities during the creation of laboratory based data review listings.
• Performs laboratory result and unit data review and reconciliation.
• Manage discrepancy life cycle from investigation through query adjudication based on study team needs..
• Attends internal, vendor and CRO meetings as directed.
• Performs any and all other tasks and activities as requested.

Required Qualifications and Preferred Background

• Bachelor’s degree in life sciences, math, or related field required.
• Minimum of three clinical data management experience. 
• Oncology research experience is preferred.
• Knowledge of lab review process is preferred.
• Proficiency in MS Office (Outlook, Word, Excel, PowerPoint)
• Experience in MS Project is preferred.
• Experience with web-based Electronic Data Capture (EDC) and clinical data management systems and industry wide thesauri, such as MedDRA and WHO Drug.
• Excellent time management skills and a proven ability to work on multiple projects at any given time in a fast-paced environment.
• Available to assist the study team to achieve important data deliverables across all North American time zones.
• Self-driven and high achieving while maintaining a focus on quality in all aspects of work.

Available locations for this role

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


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

Roles and Responsibilities of the Position

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

Required Qualifications and Background

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

Available Locations for this role

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




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

Roles and Responsibilities 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 sequencing applications related to cell free, single cell and FFPE sequencing
• Support existing and novel targeted panel development for NGS
• Responsible for establishing and updating lab SOPs and training lab scientists as needed
• 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
• Additional roles and responsibilities:
• 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:

• BS in biological sciences with 5 years of experience or MSc or PhD in biological sciences with 2-3 years of experience
• Broad experience with multiple nucleic acid and protein expression platforms, including assay design and development
• Experienced with high content, high throughput laboratory workflows with emphasis on quality and efficiency
• Demonstrated experience in working collaboratively across various scientific disciplines to meet project goals and timelines
• Flexibility to adjust priorities over time to meet organizational and scientific goals.
• Ability to work independently and as an integral part of a larger collaborative team.
• Demonstrated ability to succeed in a fast-paced environment, working on multiple projects with constantly changing priorities and deadlines
• Excellent interpersonal, written, and verbal communication skills
• Experience processing, analyzing, and interpreting large biological data sets

Roles and Responsibilities of the Position

• Lead cross-functional teams that will be responsible for novel small and large molecule 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
• 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
• Provide strategic input, in partnership with Discovery leadership, into computational and experimental validation for key new targets
• Contribute to due diligence evaluation of external opportunities, participate in KOL engagement around target programs, and help identify academic and industry partnerships and collaboration.

Required Qualifications and Background

• PhD in systems biology, molecular & cellular biology, chemical biology, or related field
• Minimum of 8-10 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 areas of cancer biology and cancer genomics
• 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

• Experience with cell engineering, and ex vivo and in vivo models of cancer
• Experience with incorporating massively parallel genetic screening data in target identification and credentialing workflow (ie CRISPR screens)
• Experience with early clinical trial studies and the development and implementation of pharmacodynamic and patient selection biomarker assays
• Experience working with external CROs to optimize internal/external resources




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

Roles and Responsibilities of the Position:

• Lead GMP QA Team and point person for GMP QA.
• Responsible for oversight of release and disposition of drug substance and drug product for clinical use.
• Negotiate Quality Agreements.
• Support new business ventures from a GMP QA perspective.
• Responsible for process improvement projects in GMP QA.
• Support transition of products between Loxo and Lilly organizations.
• Liaise with QPs for Batch release activities.
• Interact and develop relationships with contract manufacturing organizations, internal Loxo departments, and Lilly Quality departments.
• Oversight of review and approval of product specifications, product labeling, master batch records, deviations and CAPAs, etc.
• Update Quality SOPs in support of Loxo GMP Quality
• Ensure compliance with corporate policies and procedures as well as health authority laws and regulations.
• Support regulatory inspections of Sponsor and contract organizations.
• Provide reviews of regulatory dossiers (IND, IMPD, NDA)
• Mentor junior Quality team members and act as a back up to the Vice President.

Required Qualifications and Background:

• Minimum BS, master’s degree or PhD with focus in Chemistry, Life Sciences, Engineering or similar technical field.
• 10+ years current work experience in pharmaceutical industry Quality Assurance required.
• Knowledge of CMC and analytical laboratories in small molecules and Biologics.
• Experience in working in all phases of drug development (Phase 1 through commercial)
• Working knowledge of ex-US batch release requirements (i.e., Qualified Person requirements)
• Solid and demonstrable knowledge of international GMP regulations and guidelines, and industry practices
• Expert knowledge in Quality systems
• Experience supporting regulatory inspections
• Strong organization and time management skills.
• Attention to detail with an ability to perform critical review of various types of documents.
• Outstanding written and verbal skills.
• Demonstrated ability to work well with other accomplished professionals within and across functions/teams. Willing collaborator.
• Strong written and oral communication skills.
• Ability to multi-task and shift priorities rapidly to meet tight deadlines.
• Detail oriented and well organized.
• Good and thoughtful listener.
• Critical thinker and solution oriented
• Enthusiastic, self-motivated, self-starter, and keen to improve processes and overcome inefficiencies.
• Proficient in Microsoft Office suite and applications. 

Available locations for this role:

• Stamford, CT
• South San Francisco, CA
• Louisville, CO
• Indianapolis, IN

Roles and Responsibilities of the Position

• Primary responsibility for daily safety case review and will contribute to the design, analysis, interpretation, and reporting of safety findings within a program and will review and contribute to the content of protocols, Investigator Brochures, Clinical Study reports, regulatory submissions and responses, and other program documents.
• Primary responsibility for reviewing safety data periodically and on an ongoing basis to ensure quality control (QC) as required by program needs.   
• May participate in or lead review of protocol deviations (PD) which may impact patient safety as required by program needs.
• May participate in, or lead safety development contributions to, due diligence or other business development activity.  As required by program needs, contributes in partnership with research colleagues to design and implement translational strategies.
• Actively solicits opinion leader interactions related to the disease area(s); partners with Clinical leads, Commercial and other functions in these activities as required, consistent with corporate policies, to ensure that broad cross-functional perspectives are incorporated into Safety Development Plans and protocols as appropriate.
• Stays abreast of professional information and technology through conferences, medical literature, and other available training, to augment expertise in the therapeutic and safety area. May represent Loxo at key external meetings.
• Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. May serve as a safety representative for key regulatory discussions.
• Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures, organization policies and to all other quality standards in conducting research. 

Required Qualifications and Background

• MD, Board certified or eligible; PhD advantageous.
• At least 2 years of oncology experience strongly preferred.
• Ability to exercise judgment and address complex problems and create solutions for one or more projects.
• Ability to develop collaborative working relationships with physicians, expert consultants, and contracted vendors.
• Strong analytical mind and problem-solving skills, attention to detail, strong organizational skills, and ability to work independently and as part of a team.
• Proven leadership skills and ability to bring out the best in others on a cross-functional global team. Must be able to lead through influence.
• Proven ability to interact externally and internally to support a global scientific and business strategy.
• Excellent English written and verbal communication skills. Strong document management skills, including proficiency with MS Word, EndNote, PowerPoint and Excel.
• Demonstrated ability to work well with other accomplished professionals within and across functions/teams. Willing collaborator.
• Strong communication skills both written and oral.
• Ability to multi-task and shift priorities rapidly to meet tight deadlines.
• Professional demeanor and appearance and an excellent written and verbal communicator.
• Good and thoughtful listener.
• Enthusiastic, self-motivated and keen to improve processes and overcome inefficiencies.

Roles and Responsibilities

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

Require Qualifications and Preferred Background

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

Roles and Responsibilities of the Position

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

Required Qualifications and Background

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

Available locations for this role

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


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

Roles and Responsibilities of the Position

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

Required Qualifications and Background

• BS/MS in biological sciences, computer science, engineering, or other relevant field with 5+ years of laboratory automation experience.
• Extensive knowledge and experience designing and supporting laboratory automation and liquid handling.
• Experience with high-content, high-throughput laboratory workflows with emphasis on quality and efficiency.
• Experience converting manual protocols into automated processes, process optimization, and workflow efficiencies on automated equipment.
• High agility to learn new technologies, with an affinity for automation and high-end equipment.
• Demonstrated experience in working collaboratively across various disciplines to meet project goals and timelines.
• Flexibility to adjust priorities over time to meet organizational and scientific goals.
• Ability to work independently and as an integral part of a larger collaborative team.
• Demonstrated ability to succeed in a fast-paced environment, working on multiple projects with constantly changing priorities and deadlines
• Outstanding interpersonal, written, and verbal communication skills.

Additional Preferred Qualifications

• Experience with ECHO acoustic dispensers, HighRes PRIME liquid handling, and  lab automation scheduling software (e.g., Cellario) is highly preferred.


Loxo Oncology, Inc. (Loxo) currently anticipates that the base salary for the Manager level could range from between $103,200 to $151,423 and will depend, in part, on the successful candidate’s qualifications for the role, including education and experience. This position 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:

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

Required Qualifications and Background:

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

Roles and Responsibilities of the Position

• Works as the study statistician collaboratively with statistical programmers, other biostatisticians, clinical research associates, clinical data managers and other development functions to meet project and study deliverables for statistical data analysis and reporting.
• Ensures appropriate use and implementation of statistical methodologies
• Interacts with and oversees statistical vendors as needed.
• Provide instructions for derivations and analyses to statistical programming to ensure quality of deliverables.
• Develop statistical programs as necessary to perform analyses, prepare data displays and verify the correctness of data and analyses.
• Help design data capture methods and select appropriate study endpoints for clinical programs.
• Contribute to development of policies, procedures, and standards within the biostatistics department. 

Required Qualifications and Background

• PhD with minimum 2-4 years OR master’s with minimum 4-6 years of experience in statistics/biostatistics/related field is required
• Minimum 1 year of clinical development experience in the pharmaceutical/biotech industry is required
• Knowledge of clinical trial design, drug development regulations pertinent to statistical analysis, and sound understanding of statistical applications for clinical trials is required
• Proficient SAS programming skills and an understanding of CDISC models and standards are required
• Oncology experience is preferred.
• Ability to plan, develop timelines, multi-task, and shift priorities rapidly to meet tight deadlines.
• Excellent writing, interpersonal and communication skills.

Available locations for this role

• South San Francisco, CA


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

Roles and Responsibilities of the Position

• Perform data analysis using primarily the SAS programming language for the summary and interpretation of clinical trial data.
• 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.
• 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.
• Contribute to the development and review of CRFs, Data Management Plan, Data Validation Plan and edit check specifications.
• Implement and contribute to statistical analysis plans; provide additional expertise in the analysis of clinical trial as it relates to protocol development, case report form design and data collection. 
• Work with Statisticians and development team members to specify and perform ad hoc and prespecified analyses.  
• Establish monitoring of data transfers for ongoing trials to identify study conduct or data quality issues.
 

Required Qualifications and Preferred Background

• Bachelors or Masters degree in Statistics, Life Sciences, Computer Sciences, Mathematics, or related field with a minimum of 5-7 years Pharmaceutical/Biotech programming experience is required
• Experience with NDA submissions, integrated summaries (ISE/ISS) and Clinical Study Reports statistical deliverables is preferred.
• Expert proficiency SAS Programming language is required.
• Experience in the analysis of complex oncology clinical trial data is preferred.
• Experience in managing multiple projects
• Proven ability to work both independently and in a team setting.
• Strong well-rounded technical skills (EDC systems, MS Word, Excel, PowerPoint).
• Ability to work effectively in a fast-paced environment with a positive “can-do” proactive attitude. 


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

Roles and Responsibilities of the Position:

• Serve as Loxo Oncology’s scientific representative to the pathology, diagnostic laboratory and medical communities; facilitate the appropriate exchange of scientific information.
• Communicate clinical diagnostic and technology trends which may impact biomarker testing on both early and late phase assets  
• Support companion diagnostic development timelines associated with assigned programs
• Provide content expertise through knowledge transfer and training materials to the medical affairs team in the development and implementation of the launch strategy for assigned programs.
• Work closely and in synergy with product development teams as well as therapeutic medical affairs team
• 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/Molecular Pathology board eligible or certified; and 3 + years of experience in a clinical lab setting.
• 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. 

Strongly desired additional skills and experiences:

• 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:

• Participate in building a team with scientists and associates (at various levels) to be part of the larger Protein Engineering Group of the Large Molecule Discovery team at Loxo Oncology
• Work with other Protein Engineering team members to screen, characterize and investigate, using analytical and biophysical platforms and methodologies, large biologicals comprised of antibodies, antibody conjugates, multi specifics and other modalities, created for treatment of several oncological indications
• Hands-on role to design, independently execute key experiments for biophysical characterization of these large molecules from early discovery to early development stage that includes accelerated stability and developability assessments
• Experience in lead optimization would a plus
• Interact and collaborate with other teams across the company to provide biophysical 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
• Liaise with CROs and vendors for contract work and evaluations
• Participate in long-term strategies for creation of innovative solutions and intellectual property for securing FTO for Loxo

Required Qualifications and Preferred Background:

• Ph.D. in life or analytical sciences or equivalent fields with at least 5 years of relevant job experience in the biopharma industry with good understanding of drug development process of therapeutic antibodies, antibody conjugates, bi and multi-specific molecules and other modalities.
• Extensive demonstrated expertise in characterization of biomolecular interactions using various industry standard SPR, BLI, and other relevant platforms for characterization of high/low affinities, concentrations, cross-blocking, activity, binding models, heterogeneities, and other product defining characteristics
• Experience in laboratory automation for liquid handling and screening
• Experience with spectroscopic techniques for characterization of biomolecules (e.g. UV/Fluorescence)
• Knowledge of biophysical techniques and platforms for characterization of physical, chemical, and conformational stabilities of biologics. Experience with cIEF, CE-SDS, or DSF or SEC-MALS would be a plus
• Knowledge of antibody design and engineering approaches (e.g. modeling, cloning & expression) for optimization of CMC properties will be a plus
• Hands-on experience with vendor provided software for biosensor data analysis and visualization. Experience with additional software tools such as GraphpadPrism, R, Matlab, Spotfire etc would be a plus
• Prior experience participating in team efforts for antibody lead panel generation, lead optimization and IND enabling studies
• Supervision of a team by providing clear direction, setting expectations, and mentoring young scientists
• Must have a can-do attitude to take on challenging projects and innovative ideas to accomplish in a collaborative matrixed organization
• Excellent communication skills and with strong organizational abilities

*Roles and Responsibilities of the Position:

• Oversee the integration of biomarker and diagnostic development plans in clinical development with the current oncology treatment landscape, registrational and launch needs for the asset and with external competitors.
• Ensure individual biomarker scientist plans are developed and implemented optimally according to the strategic needs of the assets and are aligned to company positions and guidelines.
• Create and foster strong strategic partnerships with colleagues that include Biomarker Operations, pre-Clinical Development, Clinical Operations/Development, Dx Regulatory Affairs and Dx Medical Affairs. 
• Apply Biomarker Development strategy to the design and interpretation of clinical trials.
• Provide strategic input into data analysis, and engage in critical thinking, to deliver key data generation and interpretation essential for decision making as well as public scientific disclosure.
• Lead integration with functional teams such as discovery, translational medicine, data science, clinical science etc. to ensure timely analysis, interpretation and disclosure of data to support development of our oncology pipeline.
• Demonstrate substantial and relevant knowledge of scientific and medical literature with genomics and biomarker expertise and its application to strategic drug development and registration.
• Apply scientific and operational knowledge to identify and analyze problems and information of considerable complexity and implement effective plans and solutions. Collaborate with operational teams to ensure cohesive planning and strategy.
• Ability to prioritize effectively and meet multiple deadlines successfully with attention to detail, setting high performance standards.
• Proactively  generate  ideas  for  improvements  and  take  action  to  solve problems and achieve goals beyond what is required.

*Required Qualifications and Preferred Background:

• PhD required along with 5-7 years of biomarker experience within an academic or industry setting.
• Strong preferably within laboratory-based cancer research or clinical trials is preferred.
• Clinical   trial   expertise   along   with   experience  in  oncology  with  drug development highly desirable. 
• The skills required for success in the job include scientific and analytic ability, ability to think strategically and tactically, an interest in applied clinical research, an ability to work effectively in multifunctional teams and  excellent organizational and communication skills.
• The candidate must demonstrate proven ability to evaluate, interpret and present   complex  scientific  data  to  both  technical and non-technical audiences.
• Demonstrated ability to work well with other accomplished professionals within and across functions/teams.

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)
• Maintain focus on project deliverables and prioritize experiments and efforts accordingly
• Oversee/perform assays to identify the drug candidate and 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
• 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.
• Experience in leading a project (i.e., to IND, FHD and/or out licensing) highly preferred
• Experience writing reports and supporting documentation for regulatory filings preferred
• Hands-on experience with in-vitro assay development for large molecules including ADCs and other modalities
• 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 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


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

Roles and Responsibilities 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

Required Qualifications and Background

• 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


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

Roles and Responsibilities for the Position

• Support Project Manager and functional leads of medicinal chemistry, biology, DMPK, CMC, and toxicology (and other key stakeholders) in the planning, execution, and tracking project activities, ensuring alignment of project deliverables with strategic goals.
• Support the drafting of project updates and reports, PowerPoint slide presentations, memos as needed for projects and maintain project document repository.
• Support in the creation and maintenance of organizational documents and tools, e.g., screening cascades, data summaries, project timelines, Spotfire dashboards, compound demand-supply forecasts, and various other trackers to ensure clear, effective, transparent, and efficient implementation of projects.
• Support project outsourcing needs by coordinating with team members to manage activities involving internal and external collaborators and vendors.
• Support day-to-day operational activities by coordinating with different functional teams, legal, procurement, finance, and other internal and external stakeholders.
• Contribute to building positive, collaborative teams for seamless project execution.

Required Qualifications and Background

• Bachelor’s degree in sciences with 2 years of experience in life sciences industry.
• Ability to work collaboratively in teams.
• Excellent verbal, written communication, and interpersonal skills.
• Ability to multi-task and shift priorities rapidly to meet deadlines.
• Detail oriented and well organized.
• Enthusiastic, self-motivated, and with excellent time management skills
• Proficient in Microsoft Office suite and applications

Roles and Responsibilities for the Position

• Establish strategic project goals and translate goals into project plan(s) with clear deliverables, milestones, and go/ no-go decisions.
• Establish project strategic objectives by collaborating with Loxo Small Molecule- Discovery leadership team.
• Engage with functional team leads of medicinal chemistry, biology, DMPK, CMC, and toxicology (and other key stakeholders) to plan, execute, and track project activities, ensuring alignment of project deliverables with strategic goals.
• Actively manage assays and studies conducted at external collaborators and vendors to meet outsourcing needs as needed.
• Actively facilitate project meetings: create agendas, minutes, and track action items.
• Create and maintain organizational documents and tools, e.g., screening cascades, data summaries, project timelines, Spotfire dashboards, compound demand-supply forecasts, and various other trackers to ensure clear, effective, transparent, and efficient implementation of projects.
• Create project updates, reports, presentations, and memos and maintain project document repository in collaboration with team members.
• Proficient in adaptive communications; effectively manage communications vertically and horizontally in a cross-functional environment.
• Proactively contribute to and manage project communications. Identify gaps and ambiguities in communication channels and address them to maintain alignment across the team.
• Drive day-to-day operational activities by coordinating with stakeholders from different functional departments – legal, business operations, procurement, finance, and other relevant functional areas as needed.
• Proactively identify gaps in processes and actively create processes to meet project needs.
• Adaptive to change in priorities and able to drive project outcomes ensuring re-alignment with project deliverables in changing landscape.
• Contribute to building positive, collaborative teams across scientific disciplines, and encourage sharing of new ideas and creative ways to solve problems often needed in drug discovery research.

Required Qualifications and Background

• BS, MS, or PhD  in chemistry, biology, or related sciences.
• Small molecule drug discovery experience: BS with 7 years, MS with 4 years, or PhD  with 2 years. Part of the experience could come from project management/ alliance management responsibilities in pharmaceutical research & development.
• Must be self-motivated and have excellent time management skills
• Excellent verbal, written communication and interpersonal skills.
• Excellent organizational skills, efficient, with strong attention to detail
 
Additional Preferences:  
• PMP certification is preferred, but not required
• Proficient in identifying and applying tools to effectively manage and track projects - MS Office suite, MS Project
• Experience with data visualization software, such as Spotfire
• Create and implement new tools and processes customized for furthering discovery research

Roles and Responsibilities of the Position:

• Prosecute biophysical assays to identify and characterize small-molecule modulators using a variety of techniques and detection methods, including chromogenic, MS, SPR, ITC, FP, FRET and TR-FRET.
• Continuously expand our biochemical characterization repertoire by exploring and developing additional assay and technological instrumentation.
• Calculate and report assay results to the project teams.
• Document experiments and results in electronic notebook, and results database. 

Required Qualifications and Background:

• A BS or MS with 0-3+ years relevant work experience. Level commensurate with education and experience.
• Excellent interpersonal skills with ability to communicate and interact well with colleagues, vendors, contractors, scientific advisors, and staff at all levels.
• Highly organized and detail oriented with excellent analytical, documentation, and multi-tasking skills
• Committed continual learner, who is accustomed to staying current with the latest scientific breakthroughs in structure-based drug design and biophysics.
• Expertise in other methods of enzymology or biophysical characterization and structural biology is a plus
• Protein Purification and characterization a plus

Roles and Responsibilities for the Position

• Develop a user-friendly web interface to automate scientific workflows, standardize analysis scripts, and organize -omics datasets.
• Utilize third-party API’s and SDK’s to communicate and integrate with off-the-shelf and custom software.
• Work closely with scientists and collaborators to understand their needs, propose solutions and implement new features.
• Work jointly with other developers and engineers to maintain best practices within a bioinformatics cloud ecosystem.

Required Qualifications and Backgroun

• Bachelor’s/Master’s/PhD in computer science, bioinformatics, or equivalent experience.
• Exposure to computer science coursework including data structures and algorithms.
• 2+ years of full-stack web development with at least one Javascript framework (React, Angular, NodeJS).
• A strong knack for creating visually appealing UX/UI, and ability to abide by clear design rules.
• Firm understanding of back-end web development design patterns and principles (RESTful API’s, JSON, SQL/NoSQL databases).
• Experience communicating and executing systems design proposals.
• Comfortable with the Linux Command Line on a POSIX-compliant system.
• Proficiency in one or more scripting languages (Python/Perl/Go/Bash).
• Domain knowledge of NGS bioinformatics pipelines, workflows, and analyses a plus.
• Working knowledge of AWS Cloud Technologies (S3, Lambda, RDS, EC2, SES, Cloudwatch) a plus.
• Excellent communication skills, both written and verbal.


Loxo Oncology, Inc. (Loxo) currently anticipates that the base salary for the Senior Scientist level position could range from between $103,200 to $151,423 and the Principal Scientist position would range from $118,700 to $172,13, 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

• South San Francisco, CA
• Alexandria Center, NY
• US Based- Remote

Roles and Responsibilties of the Position

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

Required Qualifications and Background:

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

Preferred Qualifications:

• Single B cell cloning or hybridoma based antibody discovery experience


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

Roles and Responsibilities of the Position

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

Required Qualifications and Background

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

Preferred Qualifications

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




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

Roles and Responsibilities

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

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

Roles and Responsibilities for the Position

• Generate protein-small molecule complex x-ray crystal structures with hands-on lab involvement throughout the entire gene to structure process including protein expression, purification, crystallization, and structure determination.
• Coordinate protein construct design, expression, and purification with the project team to support biochemical and biophysical assays.
• Rapidly communicate scientific results and insights to the team.
• Identify, evaluate, and manage vendors for outsourced services and studies.
• Collaborate with colleagues throughout the company to ensure structural work meets the program needs and results are appropriately interpreted.
• 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. 
• Develop and continually advance one’s knowledge base on genetically targeted drugs and structure-based drug design.
• 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.
• In the future, this position’s responsibilities may include supervision of scientists and associates.

Required Qualifications and Background

• PhD in Biochemistry, Biophysics, Chemistry, or related field
• Ideal candidate will have with 5+ years hands-on gene to structure protein-small molecule crystallography experience in a biotech/pharma setting.
• Experienced in crystallization of protein-small molecule complexes and high-resolution x-ray structure determination
• Extensive experience in protein construct design, expression, purification, and characterization
• 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 structural biology.
• Experience in other methods of biophysical and structural biology, such as Cryo-EM, is a plus.
• A learners mindset.


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

Roles and Responsibilities of the Position

• Create, develop and credential quantitative cellular assays
• Establish robust high-throughput screening assays
• Design and manage pre-clinical studies
• Conceive and lead collaborative projects on biomarker-driven programs
• Evaluate emerging technologies, methods, and service providers
• Participate and thrive in an interactive, team-oriented culture
• Directly manage and mentor lab-based staff

Required Qualifications and Background

• PhD in systems biology, molecular/cellular biology, chemical biology, or related field
• 0-2 years of postdoctoral and/or hand-on research experience, preferability in biotech/pharma setting
• Experience in relevant areas of cancer biology and cancer genomics
• Outstanding communication, writing, and presentation skills are a must
• At least one first author publication
• Enthusiastic, self-motivated and keen to improve processes and overcome inefficiencies
• 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

Ideal candidate will also have

• Experience with cell engineering such as knock-in and knockdown cell lines with CRISPRand/or other technologies
• Experience with functional genomics screens
• Experience with flow cytometry and general molecular biological techniques including q-PCR, signaling experiments, microscopy, assays for protein-protein interactions and Western Blot etc.
• Experience working with external CROs


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

*Roles and Responsibilities of the Position:

• Design and develop novel biophysical assays to identify and characterize small-molecule or biological modulators using a variety of techniques and detection methods including chromogenic, MS, SPR, ITC, FP, FRET and TR-FRET.
• Experimentally explore biological consequence of mechanism of inhibition by coordinating experiments with our cell biology team.
• Creatively address biologic/biophysical questions across a wide variety of techniques and technologies.
• Continuously expand our biochemical characterization repertoire by exploring and developing additional assay and technological instrumentation.
• Calculate and report assay results to the project teams.
• Document experiments and results in electronic notebook, and results database.
• Software coding experience is a plus

*Required Qualifications and Background:

• A 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, minimum of 10 years for BS, >5 years for MS and >0-3 years for PhD, either in industrial or academic environment.
• Excellent interpersonal skills with ability to communicate and interact well with colleagues, vendors, contractors, scientific advisors, and staff at all levels.
• Highly organized and detail oriented with excellent analytical, documentation, and multi-tasking skills
• Committed continual learner, who is accustomed to staying current with the latest scientific breakthroughs in structure-based drug design and biophysics.

Roles and Responsibilities of the Position

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

Required Qualifications and Background

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


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

Additional Preferred Qualifications

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


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

Roles and Responsibilities of the Position:

• Design, execute and oversee the execution of in vivo studies with pre-clinical  discovery and translational biology teams
• Interact and collaborate with various discovery technologies functional teams to develop and implement novel in vivo models
• Prepare drug solutions and inoculations, multiple route drug administration, animal health monitoring, anesthesia, blood samplings, necropsies, xenografts, syngeneic mouse models, humanized mouse models
• Culture tumor cells according to SOPs and contribute to the development of SOPs
• Work collaboratively with the discovery and clinical teams to support retrospective and exploratory efforts for clinical programs
• Perform cardiac, retro-orbital bleeds, and tumor injections
• Perform tumor measurements using calipers
• Harvest tumor and tissue samples from treated animals to help establish PK/PD and toxicity measurements
• Process blood and tissue samples for monitoring PD markets, hematological and tissue toxicities
• Liaise with CROs and vendors to outsource activities, provide input to management team on vendor selection
• Stay current on cutting edge technologies and work collaboratively with the in vivo team to validate and implement new in vivo model systems
• Provide scientific expertise on practical implementation of various in vivo applications to support projects across the entire Loxo organization
• Work with the entire in vivo team to ensure all instrumentation is properly maintained and calibrated
• Provide scientific expertise when determining organizations to strategically partner with
• Proper documentation and archiving of data and analyses
• Work interactively with project teams and discovery teams to plan and execute experiments as well as be involved in data interpretation and preparation of study reports
• Work interactively with project teams as an in vivo pharmacology expert to ensure appropriate applications and priorities are considered
• Additional roles and responsibilities:
• Communicate results via written and oral presentations at project team meetings, be involved in the coordination and preparation of presentations
• Discuss results with technical as well as non-technical personnel
• Support archiving as well as curating data in internal databases
• Extensive cross functional communication and collaboration with internal and external parties
• Interrogate experimental conduct of third parties/vendors

Required Qualifications and Background:

• PhD in biological sciences with a focus in in vivo pharmacology or MSc in biological sciences with 5+ years’ experience preferably in the pharma/biotech industry
• Extensive expertise in: in vivo pharmacology, cell line xenograft establishment, humanized mouse model systems, imaging, standard flow cytometry experiments, bioanalytical functions, small animal handling, carrying out preclinical rodent oncology modeling
• Diverse experience in cell biology and biochemical techniques to monitor PK/PD relationships
• Experience in drug discovery with regulator reporting
• Proven success working in cross-functional teams in dynamic organizations
• Demonstrated experience in working collaboratively across various scientific disciplines to meet end goals of business
• Demonstrated business acumen
• Demonstrated excellence in making key strategic decisions in support of broader business goals
• Excellent written and verbal communication skills
• 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 in vivo studies

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

• 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 1-3+ years of postdoctoral and/or hand-on research experience, preferability in biotech/pharma setting.
• Experience in relevant areas of cancer and molecular biology.
• Outstanding communication, writing, and presentation skills is a must.

Additional Preferred Qualifications

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




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

Roles and Responsibilities of the Position

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

Required Qualifications and Background

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




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

• NOTE: this position can be located in Stamford, CT or South San Francisco, CA OR Based Remotely

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 Preferred Background

• BS or MS 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.




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

Roles and Responsibilities of the Position

• Design vectors to generate transgenic mouse models to study novel targets.
• Maintain and establish various mammalian cell lines used to credential novel targets.
• Design, plan and/or execute in vivo experiments by using mouse models to evaluate the outcome of tumor progression in mouse models for different cancers.
• Perform cellular and biochemical assays to evaluate the outcome of various genetic or chemical perturbations. 
• Mouse colony management.  
• 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.
• Mouse experience is highly desired but not required.
• 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.
 
Loxo Oncology, Inc. (Loxo) currently anticipates that the base salary for the Senior Associate Scientist level position could range from between $67,850 to $99,563 and the that the base salary for the Scientist 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.

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 Senior Associate Scientist level could range from between $67,850 to $93,563 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. 




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

Roles and Responsibilities of the Position:

• Provide strategic and technical/medical leadership over:
o          Trial enrollment and patient selection criteria, methods and approaches including patient referral programs for all oncology portfolio assets
o          Global Clinical Diagnostics development plan in partnership with Clinical Diagnostics Development and Biomarker Development. This includes clinically relevant vendor selection, validation design and review of submission documents
o          Representing Loxo Oncology at Lilly in external engagements with professional societies, regulators and policy groups, relevant to Diagnostics, in partnership with VP of Clinical Biomarkers and Diagnostic Development
o          Training and upskilling a Medical Affairs Diagnostic Lead for each relevant asset
o          Mentoring and training junior pathologists and partnering with pathologists at Lilly
o          Identifying and filling diagnostic related knowledge gaps relevant to the pipeline and marketed assets
•           Serve as consultant for:
o          Clinical biomarker assay selection and exploratory approaches
o          Commercial and medical affairs tactics relevant to diagnostics in the peri-launch period, while upskilling the Diagnostics Medical  Affairs Lead
o          International Business Unit (IBU) peri-launch strategy for relevant assets in collaboration with the IBU Diagnostic Lead
 

Required Qualifications and Preferred Background:

• MD with formal Training in Anatomic Pathology, American Board of Pathology – Anatomic Pathology/Molecular Pathology board eligible or certified; and 8 + years of experience in a clinical lab setting.
• 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. 

Strongly desired additional skills and experiences

• 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

Available locations for this role:

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

Roles and Responsibilities for the Position

• Establish strategic project goals and translate goals into project plan(s) with clear deliverables, milestones, and go/ no-go decisions.
• Establish project strategic objectives by collaborating with Loxo Small Molecule- Discovery leadership team.
• Engage with functional team leads of medicinal chemistry, biology, DMPK, CMC, and toxicology (and other key stakeholders) to plan, execute, and track project activities, ensuring alignment of project deliverables with strategic goals.
• Actively manage assays and studies conducted at external collaborators and vendors to meet outsourcing needs as needed.
• Actively facilitate project meetings: create agendas, minutes, and track action items.
• Create and maintain organizational documents and tools, e.g., screening cascades, data summaries, project timelines, Spotfire dashboards, compound demand-supply forecasts, and various other trackers to ensure clear, effective, transparent, and efficient implementation of projects.
• Create project updates, reports, presentations, and memos and maintain project document repository in collaboration with team members.
• Proficient in adaptive communications; effectively manage communications vertically and horizontally in a cross-functional environment.
• Proactively contribute to and manage project communications. Identify gaps and ambiguities in communication channels and address them to maintain alignment across the team.
• Drive day-to-day operational activities by coordinating with stakeholders from different functional departments – legal, business operations, procurement, finance, and other relevant functional areas as needed.
• Proactively identify gaps in processes and actively create processes to meet project needs.
• Adaptive to change in priorities and able to drive project outcomes ensuring re-alignment with project deliverables in changing landscape.
• Contribute to building positive, collaborative teams across scientific disciplines, and encourage sharing of new ideas and creative ways to solve problems often needed in drug discovery research.

Required Qualifications and Background

• BS, MS, or PhD  in chemistry, biology, or related sciences.
• Small molecule drug discovery experience: BS with 7 years, MS with 4 years, or PhD  with 2 years. Part of the experience could come from project management/ alliance management responsibilities in pharmaceutical research & development.
• Must be self-motivated and have excellent time management skills
• Excellent verbal, written communication and interpersonal skills.
• Excellent organizational skills, efficient, with strong attention to detail
 
Additional Preferences:  
• PMP certification is preferred, but not required
• Proficient in identifying and applying tools to effectively manage and track projects - MS Office suite, MS Project
• Experience with data visualization software, such as Spotfire
• Create and implement new tools and processes customized for furthering discovery research

Roles and Responsibilities of the Position:

• Provide recombinant protein expression and protein purification expertise to deliver proteins central to research activities for small molecule discovery.
• Understand the quality of proteins required for functional and biophysical assays, and develop protocols to deliver well characterized proteins accordingly.
• Execute projects in an efficient manner, working with aggressive timelines.
• Values quality over quantity, with the ability to prioritize.
• 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 emerging technologies by reading scientific literature.
• Proactively investigate new or different technologies, methods, and service providers to ensure our work is being done in a scientifically sound, efficient, and reasonable way

Required Qualifications and Preferred Background:

• BA/BS/MS/PhD in protein sciences, biology, biochemistry, molecular biology, or a related field along with hands-on experience, working in a laboratory in a biotechnology/pharmaceutical setting
• (3+ years’ experience with a PhD; 5+ years’ experience with an MS degree; 8+ years’ experience with BS/BA degree); may also consider experience out of an academic/research setting.
• Strong team player who inspires colleagues to solve difficult problems and develop efficient workflows.
• Experience designing expression constructions for functional assays and crystallography
• Proficient with molecular biology techniques including cloning
• Expertise with a variety of protein expression systems including E. coli and Baculovirus infected insect cells.
• Expertise with protein purification techniques such as IMAC, SEC, IEX and affinity chromatography is required, ideally utilizing the AKTA FPLC systems.
• Expertise with protein characterization techniques such as LCMS, western blotting, and thermal stability assays, is desirable.
• Familiarity with biophysical and functional techniques such as SPR, ASMS, fluorescent binding assays, and enzyme kinetic assays is beneficial.
• 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 and ability to flex between protein expression/purification/characterization is a must.
• Highly organized with excellent analytical, documentation and multi-tasking skills.

Roles and Responsibilities of the Position:

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

Required Qualifications and Preferred Background

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

Roles and Responsibilities for the Position

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

Required Background and Qualifications

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


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

Roles and Responsibilities for the Position

• Work closely with Discovery Project teams to influence programs at TPP design, lead optimiztion, candidate seeking and nomination.
• Utilize PBPK and translational modeling tools to enable human PK projections throughout the life of a program
• Evaluate and guide novel in vitro tools and methodology to improve prediction of human PK
• Proactively lead cutting edge effort to build and refine PBPK models for novel drug modalities (covalent inhibitors, PROTACs, PPI’s etc.).
• Liaise with DMPK, discovery biology/pharmacology and clinical scientists to generate data and knowledge supporting the build-up of translational, mechanistic models
• Ensure communication is effective and clear for internally and externally on topics related to PBPK, translational modeling and simulation, human PK and DDI prediction
• Keep abreast of emerging literature and science in modeling and in vitro approaches

Required Qualifications and Preferred Background

• Bachelors, Masters, or PhD with 0-4 (PhD), 8-10 (MS), or 10-12 (BS) years of experience in pharmaceutical or relate
• Hands-on project experience in PBPK modeling and simulation through internship, industry research collaboration, or direct industry experience strongly preferred.
• Successful track record of applying PBPK into projects
• Strong understanding of ADME, PK and DDI concepts as well as significant theoretical and practical understanding of own scientific discipline
• Focus on and passion for data analysis, solving technical problems and applying new technologies to further scientific goals.
• Hands-on experience in the use of commercial PBPK modeling software (SimCyp or GastroPlus is preferred)


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

Available Locations for this Role

• US Based-Remote
• Boulder, Colorado
• San Diego, CA

Roles 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 Thermo or Bruker mass spectrometers 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 Qualification and Background

• Ph.D. in Chemistry, Biology, Biochemistry, or related field
• Ideal candidate will have hands-on experience with protein characterization and modern proteomics.
• 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.


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

Roles and Responsibilities of the Position

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

Required Qualifications and Background

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

Available Locations for this role

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




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

Role and Responsibilities of the Position

• In collaboration with clinical and regulatory, manages 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.
• Compiles, analyzes, and summarizes data from statistical tables and other sources, as needed.
• Liaises with cross-functional team members (e.g., clinical operations, clinical science, regulatory affairs, biostatistics, nonclinical) to ensure that information is accurately captured in documents.
• Coordinates document reviews; schedules and hosts meetings to resolve team comments.
• Acts as the medical writing representative for a program; may work with medical writing contractors on a program to ensure consistency in messaging across a program.
• Participates in the development/update of departmental procedures and templates.
• Other duties as needed.

Required Qualifications and Background

• BS and at least 4 years of related experience; advanced degree (e.g., MS/PhD/PharmD) may compensate for years of experience.
• Prior medical technical writing experience within the biotech/pharmaceutical/clinical research organization (CRO) realm.
• Experience and significant participation in preparation of clinical documents for regulatory submissions (e.g., clinical protocols, Investigational New Drug applications [INDs], New Drug Applications [NDAs], Biologic License Applications [BLAs]).
• Familiarity with therapeutic area of oncology desirable.
• Exceptional written and oral communication skills; strong attention to detail.
• Ability to write and edit complex material to ensure accuracy, clarity, and effectiveness.
• Knowledge of International Council for Harmonisation (ICH) guidelines for clinical and regulatory submission documents.
• Expert abilities in Microsoft Office.
• Ability to work in a fast-paced dynamic environment that involves frequent communication with project team.
• Excellent time management skills and ability to manage several projects simultaneously.
• Ability to communicate with cross-functional team members (e.g., clinical development, biometrics, regulatory affairs, quality assurance, manufacturing, nonclinical) and incorporate diverse feedback into a high-quality document.

Roles and Responsibilities of the Position

• Lead Biomolecular NMR efforts to support the Discovery Organization in lead generation, hit validation, hit to lead and lead optimization phase of projects.
• Design and implement a variety of 1D and nD NMR experiments for quantitation, characterization of binding dynamics, conformation, and structure of ligand-biomolecule interactions
• Use multinuclear protein and ligand observed NMR methods for Fragment-Based Drug Discovery (FBDD) efforts
• Use well-manicured results from NMR spectroscopy to quickly provide go/no-go decision making to project teams
• Work seamlessly with the structural biology organization and medicinal chemistry teams to understand and rapidly address project needs
• Operate and maintain a 600 MHz cryo-probe equipped NMR spectrometer
• 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 methodologies that will improve quality, productivity, timelines and scientific impact.
• Collaborate cross-functionally with internal and external teams to deliver key decision-making results and to continue development of the analytical and medicinal chemistry capabilities
• Contribute to the scientific development of 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 collaborative environment
• Keep safety as the top priority at any time, striving to maintain a strong, generative, safety culture.

Required Qualifications and Background

• M.S. or Ph.D. in Chemistry (preferably Analytical), Biophysics, Biochemistry or other related field
• 3+ years (for Ph.D.) or 7+ years (for M.S.) of relevant post-academic experience
• Demonstrated hands-on experience with 1D-nD NMR experiments in the Biophysical NMR area with a strong publication record
• Deep theoretical understanding of 1D-nD NMR spectroscopy
• Experience with Bruker NMR hardware and software
• 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 3rd party software such as NMRPipe, Mestre and ACD
• Experience with new NMR pulse sequence development/implementation and writing/implementing python scripts
• Well versed in IT enterprise infrastructure
• Solid understanding of medicinal chemistry


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

Roles and Responsibilities for the Position

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

Required Qualifications and Background

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


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

Roles and Responsibilities for the Position

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

Required Qualifications and Background

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


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

Roles and Responsibilities of the Position:

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

Required Qualifications and Background:

• BA/BS in science or engineering. 
• A minimum of 5 years of experience working in the Biotech or Pharmaceutical FDA regulated industry in QA or a related area such as QC or CMC.
• Experience in Batch Review and Release for clinical phase products.
• Experience writing and reviewing Deviations, CAPAs, and Change Controls.
• Experience working with solid oral dosage products and/or Biologics.
• Working knowledge of cGMP’s (CFR/ICH) and applicable international regulations/guidelines.
• Experience working with Contract Manufacturing Organizations.
• Strong understanding of GMP requirements for early phase drug development.
• Attention to detail and accuracy of work.
• Ability to multitask and work in a fast-paced environment to meet tight deadlines.
• Ability to problem solve and lead process improvements
• Ability to lead cross functional meetings and make decisions
• Ability to escalate issues when necessary
• Ability to work in a cross-functional environment.
• Ability to work in a virtual manufacturing environment.
• Ability to travel both domestic and internationally.
• Demonstrated ability to work well with other accomplished professionals.
• Willing collaborator.
• Strong communication skills both written and oral.

Available locations for this role:

• Louisville, CO
• Stamford, CT
• South San Francisco, CA

Roles and Responsibilities of the Position

• With an aptitude for developing web applications and an interest in using today's technologies, you will contribute to developing tools that support LIMS database development. The successful candidate will have a flexible, learning mindset to design and deliver scientific databases, create workflows to track inventory experimental details for gene to structure processes (target details, plasmid sequences, protein purification, protein characterization, protein crystallization, synchrotron X-ray crystallographic data, crystallography datasets, cryo-EM grid preparation, cryo-EM data analysis & processing, and protein structures). This position is responsible for delivering oracle-based LIMS database informatics solutions focused on ease of data input and accessibility, to ensure data quality. The successful candidate will be responsible for implement and deploy Loxo-LIMS by coordinating with the SB-LIMS team, and internal scientists to develop web-based tools to enhance laboratory processes and data tracking. An ideal candidate would be able to design, develop, test, and debug code through the entire development cycle.

Required Qualifications and Preferred 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 using laboratory information management system (LIMS)
• Strong demonstrated programming skills in PHP and/or Perl
• Experience with SQL, Oracle PL/SQL, Oracle triggers
• Strong web skills in HTML, JavaScript, JQUERY, AJAX, and CSS
• Familiarity with designing, maintaining, and implementing relational databases
• Familiarity in working within Linux/Unix/Apache environments
• Strong SQL and database skills, preferably with Oracle databases
• Familiarity with Perl compatible regular expression (PCRE) syntax
• Experience with C#, Python, and/or TensorFlow with deep learning would beneficial
• Understanding of molecular biology, protein sciences, protein crystallization, crystallography, and cryo-EM technologies is highly desirable
• Ability to work collaboratively with other team members to develop more complex applications
• Ability to development strategies to implement, troubleshoot and migrate existing tools to newer technologies
• Excellent communication skills and desire to learn is essential


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