Senior Director, Clinical Development (MD)
PharmaBiotechClinical ResearchRegulatory Affairsmedicalregulatory submissionemacroraveinformaws
Job description
We’re here for one reason and one reason only – to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet. Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows. Job Description 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 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%. People Leader Accountabilities: Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams. Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose. Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem. The salary range for this position is: Bay Area: $302,005.00 - $390,830.00. Other US Locations: $274,550.00 - $355,300.00. Kite considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*. For additional benefits information, visit: https://www.gilead.com/careers/compensation-benefits-and-wellbeing <
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