Executive Director, Clinical Development (MD)

About this role

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

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.

We are seeking a highly motivated leader to join us as Executive Director, Clinical Development (MD) in the multiple myeloma disease area. This role will play a key role in development and oversight of cell therapy programs, collaboration with external partners, and support evaluation opportunities for expanding the clinical development program. You will lead a portfolio of clinical trial programs in cell therapy clinical development: • Accountable for the design, conduct, evaluation, close-out and reporting of clinical trials across the portfolio.

• Lead and direct the development, implementation, and execution of the clinical development strategy, which will include development of the Target Product Profile and Clinical Development Plan.

• Additional leadership or oversight responsibilities may include, but are not limited to, additional study or investigator documentation, contributions to data analysis plans, study reporting, and clinical development inputs into regulatory documentation, publications, and scientific presentations.

Responsibilities: • Leads or otherwise oversees and directs the development of the Target Product Profile and Clinical Development Plan for assigned molecules/products.

• Works closely with cross-functional leaders and teams to develop, implement and oversee the clinical development strategy for the assigned molecules / products.

• Routinely represents the assigned products in cross-functional steering and/or governance committees.

• Leads or otherwise oversees and directs clinical trial protocol design and clinical study reporting for assigned molecules/products.

• Leads both written and oral communications with health authorities.

• Provides or oversees ongoing medical monitoring for clinical trials, including but not limited to assessment of eligibility criteria, toxicity management, and drug safety surveillance.

• Leads or otherwise oversees and directs the clinical development component(s) in the preparation/review of regulatory documents, investigator brochures and development plans.

• Oversees and directs as needed the collection and assimilation of ongoing data for internal analysis and review and the preparation and/or review of data listings, summary tables, study results and scientific presentations.

• Presents scientific information at scientific conferences as well as clinical study investigator meetings. Where applicable, takes a lead on authoring scientific publications.

• May assist in the clinical evaluation of business development opportunities.

• Develops thought leader and other external relationships that can guide short and long-range clinical development strategies and direction for the disease or therapeutic area overall.

• Adheres to regulatory requirements inclusive of GCP and ICH guidelines of study conduct, and industry practices and standards including internal SOPs.

• Typically manages a team of direct reports.

Basic Qualifications: • MD/DO and 8+ years of clinical, scientific and/or drug development experience in the biopharma industry, healthcare, consulting, academia, or a related environment. 

Preferred Qualifications: • Board certification in hematology and/or medical oncology is preferred, including familiarity with clinical oncology.

• Experience in the biopharma industry is strongly preferred; submissions and conducting phase 2-3 late development studies.

• Experience in multiple myeloma disease area, and cellular therapy therapeutic area is strongly preferred.

• Extensive experience leading high-complexity cross-functional drug development strategies and plans in life sciences, healthcare, consulting, or academia, including short- and long-range strategic planning, governance, and oversight.

• Multiple years’ line management (direct reports) experience is preferred.

• Extensive experience interacting with and presenting to executives and managing large-scale budgets and other resources is strongly preferred.

• Proven track record of achieving or exceeding large-scale, complex short and long-range strategies in life sciences, healthcare, consulting, or academia.

• Expert-level of knowledge of drug development, as evidenced by proven track record in setting short and long-range drug development strategies and plans.

• Thorough understan

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