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

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 day-to-day 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, close-out 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 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.

• 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 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 pre-clinical sciences is 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 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 cross-functional strategies, plans, and strategic objectives.

• When needed, ability to travel.

Does this sound like you? If so, please apply today!