Senior Director, Clinical Development (MD)
Kite Pharma
Summary
The Senior Medical Director provides strategic and scientific leadership for one or more development programs and serves as the clinical development lead from early development through registration planning, as applicable. The role is responsible for shaping clinical development strategy, overseeing execution across multiple studies, and partnering with cross-functional teams to advance programs in alignment with corporate objectives. The Senior Medical Director is expected to influence development decisions, represent clinical development to senior leadership and external stakeholders, and contribute to portfolio and lifecycle planning.
Job description
Job Responsibilities
- Lead the clinical development strategy for one or more oncology programs, providing scientific and medical leadership from IND-enabling activities through proof-of-concept and early development milestones.
- Provide clinical oversight and medical monitoring across one or more clinical studies, ensuring participant safety, data integrity, and high-quality execution.
- Lead cross-functional teams in the design, implementation, and execution of clinical development plans and clinical studies.
- Author and review protocols, investigator brochures, clinical study reports, regulatory documents, and other key clinical development deliverables.
- Provide strategic leadership for regulatory interactions and submissions, including INDs, health authority meetings, regulatory responses, as applicable.
- Collaborate with Research, Translational Sciences, Clinical Operations, Safety, Regulatory Affairs, and CMC teams to advance development programs and achieve key milestones.
- Build and maintain relationships with investigators, key opinion leaders, scientific advisors, and other external stakeholders.
- Present clinical data and development strategies to governance committees, health authorities, scientific conferences, and investigator meetings; lead or contribute to scientific publications and presentations.
- Mentor junior physicians and contribute to portfolio strategy, business development evaluations, and external innovation assessments, as applicable.
Basic Qualifications
MD/DO with 6+ years of clinical, scientific and/or drug development experience, including substantial experience in biopharmaceutical clinical development
Preferred Qualifications
- Board certification in Hematology/Oncology or a related specialty.
- Significant experience leading oncology drug development programs with responsibility for clinical strategy and execution.
- Demonstrated experience leading first-in-human, proof-of-concept, and registrational development programs.
- Cell therapy experience preferred, including autologous, allogeneic, and/or in vivo cellular therapy platforms.
- Experience leading interactions with global health authorities and supporting major regulatory submissions.
- Demonstrated ability to influence cross-functional teams and drive decision-making in a matrix environment.
- Proven track record of scientific leadership through publications, presentations, advisory boards, and engagement with external experts and key opinion leaders.
- Experience mentoring and developing physicians, scientists, and cross-functional team members.
- Strong strategic thinking with the ability to balance scientific rigor, operational feasibility, regulatory requirements, and business objectives.
- Experience evaluating external innovation, licensing opportunities, partnerships, or business development transactions preferred.
- Demonstrated ability to thrive in a dynamic and evolving environment, effectively managing competing priorities with minimal direction.
- Willingness to travel up to 25%.
Requirements
- MD/DO with 6+ years of clinical, scientific and/or drug development experience
- Substantial experience in biopharmaceutical clinical development
- Board certification in Hematology/Oncology or a related specialty
- Significant experience leading oncology drug development programs
- Demonstrated experience leading first-in-human, proof-of-concept, and registrational development programs
- Cell therapy experience preferred
- Experience leading interactions with global health authorities and supporting major regulatory submissions
- Demonstrated ability to influence cross-functional teams and drive decision-making in a matrix environment
- Proven track record of scientific leadership through publications, presentations, advisory boards, and engagement with external experts and key opinion leaders
- Experience mentoring and developing physicians, scientists, and cross-functional team members
- Strong strategic thinking with the ability to balance scientific rigor, operational feasibility, regulatory requirements, and business objectives
- Experience evaluating external innovation, licensing opportunities, partnerships, or business development transactions preferred
- Demonstrated ability to thrive in a dynamic and evolving environment, effectively managing competing priorities with minimal direction
- Willingness to travel up to 25%
Benefits
- Medical, Dental & Vision
- Life Insurance
- Discretionary Annual Bonus
- Stock-Based Long-Term Incentives
- Paid Time Off
Company overview
Kite Pharma, Inc. is an American biotechnology company specializing in cancer immunotherapy with a primary focus on genetically engineered autologous CAR T cell therapy. Founded in 2009 and headquartered in Santa Monica, California, Kite was acquired by Gilead Sciences in 2017 for $11.9 billion. The company develops cell-based therapies that reengineer a patient's own immune cells to attack and fight cancer cells, representing a personalized approach to cancer treatment. Kite's lead product, Yescarta (axicabtagene ciloleucel), was the first CAR T therapy approved by the FDA for treating adult patients with relapsed or refractory large B-cell lymphoma. With approximately 2,000 employees and manufacturing facilities in California, Maryland, and the Netherlands, Kite operates as an independent company within Gilead Sciences while maintaining its singular focus on advancing cell therapy to treat and potentially cure cancer. The company's innovative approach represents a paradigm shift in cancer treatment, moving away from traditional pharmaceutical manufacturing to individualized cell therapies created one patient at a time.