Sr Director, Clinical Development- CAR-T; MD

Sr Director, Clinical Development- CAR-T (MD)

Position overview:

Senior physician-lead role providing clinical oversight to multiple CAR-T trials, guiding project teams to design and execute high-quality clinical studies within regulatory and corporate guidelines.

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.

• Provides ongoing medical monitoring for multiple clinical trials, including assessment of eligibility criteria, toxicity management, and drug safety surveillance.
• Ensures adherence to regulatory requirements of study conduct and industry standards of Good Clinical Practice.
• Lead project teams to design and implement clinical studies.
• Write protocols, investigator brochures, clinical study reports and review clinical trial documents.
• Conduct investigator meetings and lead site initiation visits with clinical trial investigators.
• Implement and deploy drug development strategic plans, develop contingency plans, provide technical and strategic advice, and meet milestones and budgets.
• Translate findings from research and nonclinical studies into clinical development opportunities.
• Interact with clinical investigators and thought leaders.
• Work with internal regulatory affairs team and other ethical guidelines relevant to the pharmaceutical industry, and ensure compliance with these external guidelines.
• Work with internal pre-clinical scientists, translational scientists, business and commercial organizations in a cross functional manner.
• Work in a team environment comprising clinical operations, biomarker specialists, CROs, and regulatory affairs.
• Provide clinical expertise and input for regulatory filings (i.e., BLA, MAA) as well as response to questions from regulatory authorities in the context of IND submissions, clinical trial applications or filing procedures.
• Provide clinical guidance and work in a team environment in interactions with external stakeholders (medical experts, advisory boards, patient advocacy groups) and internal stakeholders (Research, Translational Sciences, Clinical Operations, Safety, Regulatory, Medical Affairs, and Commercial).
• May present scientific information at scientific conferences as well as clinical study investigator meetings. Where applicable, take a lead on authoring scientific publications.
• May assist in the clinical evaluation of business development opportunities.

• MD/DO and 6+ years of clinical, scientific and/or drug development experience in the biopharma industry, healthcare, consulting, academia

• Board certification/specialization in hematology or oncology
• CAR-T therapeutic area experience
• Multiple myeloma disease area expertise, with experience managing Phase II or III studies experience in multiple myeloma CAR-T trials within the pharmaceutical industry.
• Drug development experience, either within industry or as a clinical investigator/physician scientist in academia, or equivalent experience; drug development experience in hematology or oncology.
• Relevant industrial or academic experience in clinical research with basic understanding of Good Clinical Practices.
• Ability to think analytically and strategically to formulate, develop, and execute clinical plans.
• Strong leadership skills with an ability to set vision, lead change, and mentor others.
• Ability to work effectively in a multidisciplinary team to cultivate an…