Senior Translational Medicine Manager

SUMMARY/JOB PURPOSE (Basic purpose of the job):

We are seeking a highly motivated and strategic Senior Translational Medicine Manager to join our dynamic team. This individual will play a critical role in bridging discovery science and clinical development, driving biomarker strategy, and enabling data-driven decisions across oncology and immunology programs. The ideal candidate combines scientific rigor with operational excellence and thrives in a fast-paced, collaborative environment.

The Senior Translational Medicine Manager develops and implements translational strategies for programs in early clinical development and continues to support clinical programs as they progress through the pipeline. The incumbent also helps to develop novel strategies to inform on dose, patient selection including tumor indications and biomarker-selected subsets, as well as combination therapies. Additional objectives include leveraging biomarker data to evaluate treatment-mediated changes in disease. The incumbent is expected to perform as the functional and subject matter expert for translational medicine in cross-functional drug development teams and will initiate, facilitate and develop external collaborations with partner companies and academic institutions.

ESSENTIAL DUTIES/RESPONSIBILITIES:

• Lead translational strategy for assigned programs from preclinical through clinical development.
• Design, implement and oversee biomarker/translational assay development, validation and sample testing for clinical studies, including characterization of pharmacodynamic, predictive and resistance markers.
• Collaborate with discovery, clinical, regulatory and external partners to align translational goals.
• Manage external vendors and CROs for sample analysis, assay development and data delivery.
• Interpret complex biological data (e.g. genomics, transcriptomics, proteomics) to inform clinical decisions.
• Contribute to regulatory submissions (IND, NDA, BLA) and author translational sections of clinical documents.
• Present findings to internal stakeholders, external collaborators and at scientific conferences.
• Contribute to the development of project-specific goals and objectives for the Translational Medicine Department.
• Interacts with commercial functions and academic institutions to provide scientific support and support company goals.
• Designs and facilitates implementation of the clinical biomarker strategies for company sponsored clinical trials.
• Serves as subject matter expert for select technical biomarker solutions (flow cytometry, proteomics, IHC and/or genomics) and scientific discipline (e.g. immunology, oncology, hematology).
• Manages data analysis, and in collaboration with data management and bioinformatics colleagues, delivers data and analysis to inform decision-making, to support regulatory interactions and to disseminate information across various forums, including publications and congresses.
• Collaborate with Biosample Management team to manage sample collection, shipment, storage and analysis.
• Works cross-functionally within Exelixis and partners with external collaborators and vendors to achieve Translational Medicine goals.
• Analyzes results from translational medicine studies and communicates to the project teams internal stakeholders.
• Interacts with pre-clinical groups to develop and implement an integrated translational medicine strategy.
• Provides state-of-the-art translational medicine solutions by keeping current on scientific and technological developments and may manage relationships with academic institutions or partner companies.

SUPERVISORY RESPONSIBILITIES:

• None.

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

Education:

• Bachelor's degree in related discipline and a minimum of nine years of related experience; or,
• Master's degree in related discipline and a minimum of seven years of related experience; or,
• PhD in related discipline and a minimum of two years of related experience; or,
• Equivalent combination of education and experience.

Experience:

• PhD, MD or PharmD in a relevant field (e.g., oncology, immunology, molecular biology)
• A minimum of 7 years of experience in the biotechnology or pharmaceutical industry or the equivalent combination of education and industry experience.
• 5+ years of industry experience in translational medicine, clinical biomarkers or related field.
• Experience with high-dimensional data analysis and biomarker platforms (e.g., NGS, IHC, flow cytometry).
• Proven track record of cross-functional collaboration and scientific leadership.
• Prior work in oncology or immunotherapy programs.
• Experience with spatial biology, single-cell technologies, or liquid biopsy platforms.
• Experience participating in clinical oncology studies with molecular targeted or immunological therapies.
• Strong experience generating scientific presentations and data with content appropriately tailored to various internal and external audiences.

Knowledge, Skills and Abilities:

• Excellent team player to build strong relationships with cross-functional leaders and peers to enable integrated and impactful translational medicine solutions.
• Strong understanding of drug development, clinical trial design, and regulatory frameworks.
• Proven track record of success in translational research/translational medicine and scientific publications.
• Expertise in a relevant platform technology (immunohistochemistry, digital pathology, flow cytometry, or genetics), including assay development, data analysis, and clinical application is required.
• Achieved completion of translational projects and preparation of project related publications.
• Embrace opportunities to learn and adapt to various processes that may be situation specific.
• Ability to work independently and cooperatively within translational medicine and cross-functionally.
• Effective communication skills to convey complex topics to senior management, external customers and collaborators.
• Has good understanding and application of technical principles, theories, concepts and techniques related to immunology.
• Excellent communication, project management, and problem solving skills.
• Applies strong analytical skills, exercises independent judgment in methods, techniques and data interpretation.

Work Environment/Physical Demands:

Our office is a modern, open-plan space that foster collaborations and creativity. Teams work closely together, sharing ideas and solutions in a supportive atmosphere. We provide all necessary equipment, including dual monitors and ergonomic chairs, to ensure a comfortable workspace.

If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us!

DISCLAIMER
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.

We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.