Vice President, Clinical Development, Head of Solid Tumors

Description

Vice President, Clinical Development (Head of Solid Tumors)

Seeking a highly motivated hands-on physician leader to serve as a Vice President overseeing our solid tumor franchise in the company's Clinical Development Group. This position will lead the company’s cellular immuno-oncology program(s) in the disease area of solid tumors. This individual will develop and implement clinical strategies and be responsible for the oversight of contracted personnel and/or organizations to advance the comapany's clinical program(s). They will also serve as a liaison between The company and clinical investigators and will maintain established and productive relationships with key opinion leaders, as well as Health Authority representatives. The ideal candidate should have experience in solid tumors, with experience in the design and conduct of clinical studies in this therapeutic area. Experience with cellular therapies is desirable. This is a full-time position based at the Company’s corporate headquarters in San Diego, California.

Responsibilities

• Provide clinical leadership of a comprehensive and integrated Clinical Development Plan for individual oncology programs from first-in-human studies through registrational studies.
• Formulate study designs, lead protocol development and collaborate with cross-functional teams in study start-up activities in collaboration with clinical investigators, key opinion leaders and Health Authorities.
• Have direct hands-on involvement in all aspects of study conduct, in collaboration with the company's clinical development and contracted personnel, in the conduct of clinical activities including data review, analysis, and reporting that conforms to the highest ethical, safety and quality standards and in compliance with the company's GCP and regulatory standards.
• Remain current on the therapeutic landscape in the relevant therapeutic areas through review of the scientific literature, interactions with key opinion leaders and other external experts and attendance at relevant scientific meetings, in order to provide input and guidance for the strategic direction of the company's programs.
• Participate as clinical contributor in the company's business development and investor-related activities.
• Play a key role in Health Authority interactions.
• Review available preclinical data that could inform the design of future clinical trials.
• Attend and present at investigator meetings and site initiation visits as applicable.
• In collaboration with appropriate cross-functional team members actively engage in the preparation of Clinical Study Reports, Annual Reports and other safety reports, Health Authority pre-meeting packages, Investigator Brochures and other periodic clinical reports.
• Collaborating with cross-functional groups, formulate publication strategy including active participation in authoring, preparation and review of manuscripts, conference abstracts and presentations and other external presentations of clinical data.
• May oversee contractors and direct reports, including people leaders.
• Inspire, influence, and motivate team members, foster open communication, set clear goals, delegate tasks, and monitor performance.

Qualifications

• M.D. and Board Certification or Board Eligibility in the field of Medical Oncology.
• 10+ years of experience in clinical research including the design and execution of solid tumor clinical trials, within a pharmaceutical or biotech environment.
• Experience or exposure to the development of adoptive cell therapies or biologic therapies is desirable.
• Experience in novel and innovative designs for early Phase studies; Phase 3 trial experience is a plus.
• Experience with U.S. and European Health Authority interactions and submission of clinical regulatory documents is desirable.
• Strong written and verbal communication skills; willingness to engage with investigators, key opinion leaders and external advisors; and ability to effectively give presentations at conferences, advisory meetings and other public forums.
• Engaged, hands-on, independent and goal-oriented mentality; willingness to work in highly dynamic work environment and embrace uncertainty.
• Ability to multi-task and willingness to flexibly contribute simultaneously in multiple facets of drug development; willingness to learn new therapeutic areas.
• Self-motivation; good judgment; strong commitment to follow up on tasks and action items; organizational, analytical, and problem-solving skills; risk identification and management; creative and innovative thinking all highly desirable.
• Strong leadership skills with ability to work within and lead and motivate a cross-functional matrixed team.
• Willingness to educate and mentor internal and external colleagues and collaborators.

Working Conditions and Physical Requirements

• Travel may be required (up to 25%).
• Subject to extended periods of sitting and standing, vision to monitor, and moderate noise levels.