Kite Pharma
Sr Director, Clinical Development- CAR-T (MD)
Kite Pharma, Santa Monica, California, United States, 90403
Sr Director, Clinical Development- CAR-T (MD)
Join to apply for the Sr Director, Clinical Development- CAR-T (MD) role at Kite Pharma. Overview: Everyone at Kite is grounded by one common goal – curing cancer. As a Senior Medical Director, you will provide clinical oversight to multiple clinical trials and guide project teams to design and implement high-quality clinical studies in alignment with department and corporate goals, regulatory requirements, and resource constraints. Responsibilities
Provides ongoing medical monitoring for multiple clinical trials, including assessment of eligibility criteria, toxicity management, and drug safety surveillance. Ensure adherence to regulatory requirements of study conduct and Good Clinical Practice. Lead project teams to design and implement clinical studies. Write/ Review protocols, investigator brochures, clinical study reports, and related trial documents. Conduct investigator meetings and lead site initiation visits with clinical trial investigators. Develop and deploy drug development strategic plans, 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; collaborate with internal regulatory affairs and other relevant teams to ensure compliance with external guidelines. Work with internal pre-clinical, translational, business, and commercial teams in a cross-functional environment. Collaborate with clinical operations, biomarker specialists, CROs, and regulatory affairs; provide clinical input for regulatory filings (e.g., BLA, MAA) and respond to inquiries from regulatory authorities in the context of IND submissions or clinical trial applications. Provide clinical guidance in interactions with external stakeholders (medical experts, advisory boards, patient advocacy groups) and internal stakeholders (Research, Translational Sciences, Clinical Operations, Safety, Regulatory, Medical Affairs, Commercial). Present scientific information at conferences and lead or co-author scientific publications when applicable. May assist in the clinical evaluation of business development opportunities. Basic Qualifications
MD/DO and 6+ years of clinical, scientific and/or drug development experience in biopharma, healthcare, consulting, or academia. Preferred Qualifications
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 in multiple myeloma CAR-T trials. Drug development experience in industry or academia; understanding of Good Clinical Practices. Ability to think analytically and strategically to formulate, develop, and execute clinical plans. Strong leadership skills with ability to set vision, lead change, and mentor others. Ability to work effectively in a multidisciplinary, inclusive team environment with open dialogue and collaborative problem solving. Excellent scientific written and oral communication skills. Experience engaging internal and external experts in constructive scientific and clinical dialogue around study design, conduct, and interpretation of results. Integrity, meticulous attention to detail, and strong ability to maintain timelines and quality. Ability to travel domestically and internationally (~20-30% travel). People Leader Accountabilities
Create Inclusion – value diverse teams and embed inclusion in leadership practices. Develop Talent – coach employees on performance and potential, providing feedback for growth. Empower Teams – align goals with organizational objectives and remove barriers to enable success. The salary range for this position is $274,550.00 - $355,300.00. Benefits include medical, dental, vision, and life insurance plans; eligibility for discretionary bonuses and stock-based incentives; paid time off; and a comprehensive benefits package. Details vary by role, experience, and location. For more information about Kite, please visit www.kitepharma.com.
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Join to apply for the Sr Director, Clinical Development- CAR-T (MD) role at Kite Pharma. Overview: Everyone at Kite is grounded by one common goal – curing cancer. As a Senior Medical Director, you will provide clinical oversight to multiple clinical trials and guide project teams to design and implement high-quality clinical studies in alignment with department and corporate goals, regulatory requirements, and resource constraints. Responsibilities
Provides ongoing medical monitoring for multiple clinical trials, including assessment of eligibility criteria, toxicity management, and drug safety surveillance. Ensure adherence to regulatory requirements of study conduct and Good Clinical Practice. Lead project teams to design and implement clinical studies. Write/ Review protocols, investigator brochures, clinical study reports, and related trial documents. Conduct investigator meetings and lead site initiation visits with clinical trial investigators. Develop and deploy drug development strategic plans, 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; collaborate with internal regulatory affairs and other relevant teams to ensure compliance with external guidelines. Work with internal pre-clinical, translational, business, and commercial teams in a cross-functional environment. Collaborate with clinical operations, biomarker specialists, CROs, and regulatory affairs; provide clinical input for regulatory filings (e.g., BLA, MAA) and respond to inquiries from regulatory authorities in the context of IND submissions or clinical trial applications. Provide clinical guidance in interactions with external stakeholders (medical experts, advisory boards, patient advocacy groups) and internal stakeholders (Research, Translational Sciences, Clinical Operations, Safety, Regulatory, Medical Affairs, Commercial). Present scientific information at conferences and lead or co-author scientific publications when applicable. May assist in the clinical evaluation of business development opportunities. Basic Qualifications
MD/DO and 6+ years of clinical, scientific and/or drug development experience in biopharma, healthcare, consulting, or academia. Preferred Qualifications
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 in multiple myeloma CAR-T trials. Drug development experience in industry or academia; understanding of Good Clinical Practices. Ability to think analytically and strategically to formulate, develop, and execute clinical plans. Strong leadership skills with ability to set vision, lead change, and mentor others. Ability to work effectively in a multidisciplinary, inclusive team environment with open dialogue and collaborative problem solving. Excellent scientific written and oral communication skills. Experience engaging internal and external experts in constructive scientific and clinical dialogue around study design, conduct, and interpretation of results. Integrity, meticulous attention to detail, and strong ability to maintain timelines and quality. Ability to travel domestically and internationally (~20-30% travel). People Leader Accountabilities
Create Inclusion – value diverse teams and embed inclusion in leadership practices. Develop Talent – coach employees on performance and potential, providing feedback for growth. Empower Teams – align goals with organizational objectives and remove barriers to enable success. The salary range for this position is $274,550.00 - $355,300.00. Benefits include medical, dental, vision, and life insurance plans; eligibility for discretionary bonuses and stock-based incentives; paid time off; and a comprehensive benefits package. Details vary by role, experience, and location. For more information about Kite, please visit www.kitepharma.com.
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