Executive Director, Clinical Development (MD) – Solid Tumors Lead

Were 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. Weve made incredible scientific breakthroughs and our pioneering personalized CAR Tcell therapies have changed the paradigm. But were 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

Everyone at Kite is grounded by one common goal curing cancer. Every single day we seek to establish a direct line between that purpose and our daytoday work. Join us in our mission!

We are seeking a highly motivated leader to join us as Executive Director Clinical Development (MD) Solid Tumors Lead. This role will play a key role in development and oversight of solid tumor pipeline cell therapy programs collaboration with external partners and support search and evaluation opportunities for expanding the pipeline. You will lead a portfolio of clinical trial programs in solid tumors cell therapy clinical development:

• Accountable for the design conduct evaluation closeout and reporting of clinical trials across the solid tumor 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 crossfunctional leaders and teams to develop implement and oversee the clinical development strategy for the assigned molecules / products.

• Routinely represents the assigned products in crossfunctional steering and/or governance committees.

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

• 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 longrange clinical development strategies and direction for the disease or therapeutic area overall.

• Adheres to regulatory requirements of study conduct and industry standards of Good Clinical Practice as well as 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.

• Experience in submission and approval of INDs and conducting phase 1 studies is strongly preferred.

• Strong background in translational and preclinical sciences is preferred.

• Extensive experience leading highcomplexity crossfunctional drug development strategies and plans in life sciences healthcare consulting or academia including short and longrange strategic planning governance and oversight.

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

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

• Proven track record of achieving or exceeding largescale complex short and longrange strategies in life sciences healthcare consulting or academia.

• Expertlevel of knowledge of drug development as evidenced by proven track record in setting short and longrange drug development strategies and plans.

• Thorough understanding of pharmaceutical regulatory requirements and impact on development and execution of clinical trials.

• Excellent communication and organizational skills. Able to distill complex matters into a clear business case and roadmap for execution. Demonstrated ability to align other leaders and garner their commitment and engagement to crossfunctional strategies plans and strategic objectives.

• When needed ability to travel.

Does this sound like you If so please apply today!

For additional benefits information visit:

Eligible employees may participate in benefit plans subject to the terms and conditions of the applicable plans.

Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid longterm durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune systems ability to recognize and kill tumors. Kite is based in Santa Monica CA. For more information on Kite please visit . Sign up to follow @KitePharma on Twitter at jobs in the United States:

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