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The Medical Director Evidence Generation Lead Head ACE ICR & Japan at Kite Pharma (a Gilead Company) provides strategic leadership for the design execution and interpretation of medical evidence generation activities supporting Kites portfolio of innovative cell therapies.
This role is central to shaping Kites evidence ecosystem driving innovation and aligning regional and global medical strategies. The ideal candidate is an experienced clinical leader with late-stage expertise a proven track record in collaborative trial design and management and a passion for transforming patient outcomes in different therapeutic areas (Multiple Myeloma Lymphoma Solid Tumors etc.)
Key Responsibilities
Strategic Leadership & Planning
Initiate direct and execute the external evidence strategic roadmap for ACE ICR and Japan to maximize impact on Kites corporate strategies under the general direction of the VP Evidence Generation.
Lead the development and execution of the external evidence generation strategy and operating plan for ACE ICR and Japan in partnership with the Medical Affairs Strategy Team.
Establish short- to mid-term (13 years) clinical and scientific evidence strategies aligned with Global Medical Affairs (GMA) and Evidence Generation functional objectives.
Conceive define and lead impactful translational development and medical external strategies to drive Kites pipeline and business.
Propose new strategic opportunities by applying scientific and clinical principles to assess potential collaborations with industry experts.
Clinical Leadership & Execution
Lead the development of strategic collaborations and clinical groups across ACE & Japan influencing a significant portion of the Kite portfolio.
Own strategic alliances in ACE ICR & Japan supporting the Kite enterprise and portfolio.
Provide scientific and medical oversight for all Medical Affairs/Kite Sponsored Studies including interventional trials non-interventional studies and strategic alliances across therapeutic areas.
Oversee the ACE ICR & Japan Investigator-Sponsored Research (ISR) and Collaborative Research (CR) programs ensuring scientific merit strategic alignment and compliance.
Serve as Medical Monitor for assigned studies ensuring timely execution data quality and regulatory compliance (GCP SOPs).
Data Interpretation & Dissemination
Lead medical review interpretation and communication of study results including drafting publications abstracts posters and presentations for internal and external audiences.
Serve as a medical expert for oversight for study data engaging with internal stakeholders and external Key Opinion Leaders (KOLs).
Cross-Functional Collaboration & Compliance
Act as decision maker advisor and subject matter expert to leadership functions (DAI to EGLT MALT KLT PT PC ERC etc.) on external opportunities and strategic alliances.
Influence senior leadership and governance bodies in setting and executing short- and long-range strategies for Evidence Generation and GMA.
Develop and cultivate external relationships to advance Kites Medical Affairs and corporate objectives.
Lead the development of the Evidence Generation functions infrastructure and local team including senior talent development.
Ensure all activities adhere to Kite/Gilead policies local regulations and the highest ethical standards; lead process and system development as needed.
Develop build and lead cross functional teams to execute Medical evidence generation collaborative research.
Qualifications
MD or equivalent medical degree.
Significant experience in the biopharmaceutical industry with relevant experience in medical affairs clinical development or evidence generation roles.
Proven leadership in designing and managing clinical trials including Phase IV and investigator-sponsored studies.
Understanding of the cell therapy landscape including regulatory and post-approval evidence needs
Preferred
Experience in CAR-T or related advanced modalities (e.g. gene therapy immuno-oncology).
Demonstrated success in leading cross-functional teams and external partnerships.
Strong strategic thinking project management and stakeholder engagement/influencing skills.
Familiarity with digital platforms and real-world data methodologies.
Other Requirements
Willingness to travel domestically up to 2030%.
Strong communication and stakeholder management skills
The role is based in Stockley Park/ UK.
It is the policy of Gilead Sciences Inc. and its subsidiaries and affiliates (collectively Gilead or the Company) to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law all employment actions relating to issues such as compensation benefits transfers layoffs returns from layoffs company-sponsored training education assistance social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds which may include an individuals gender race color national origin ancestry religion creed physical or mental disability marital status sexual orientation medical condition veteran status and age unless such protection is prohibited by federal state municipal provincial local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws. Please apply via the Internal Career Opportunities portal in Workday.
Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune systems ability to recognize and kill tumors. Kite is based in Santa Monica CA. For more information on Kite please visit . Sign up to follow @KitePharma on Twitter at Employment Opportunity (EEO)For Current Kite Pharma Employees and Contractors:
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Kite is dedicated to curing cancer. Learn about the science of cell therapy, our cancer research, and our cancer treatments in the pipeline.