Director, Clinical Development (MD)

Kite Pharma•Foster City, CA

18h

About The Position

The Medical Director provides clinical oversight to one or more clinical trials. Additionally, the Director guides the project teams to design and implement clinical studies at high quality and in a time and cost-effective manner in line with the department and corporate goals and within regulatory and resource guidelines.

Requirements

MD/DO and 4+ years of clinical, scientific and/or drug development experience in the biopharma industry, healthcare, consulting, academia

Nice To Haves

Board certification/specialization in hematology/oncology and experience managing phase 1-3 trials
Drug development experience, either within industry or as a clinical investigator/physician scientist in academia
Cell therapy, solid tumor and/or hematological malignancy experience
Demonstrated clinical development strategist with experience designing, implementing and conducting clinical trials, with emphasis on proof-of-concept and first-in-human studies
Strategic leadership and tactical skills, excellent initiative and judgment
Demonstrated ability to develop and maintain excellent working relationships with both internal colleagues and external contacts, including key thought leaders, and investigators
Demonstrated ability to work well in teams in a cross functional manner
Ability to communicate and work in a self-guided manner with scientific/technical personnel
Ability to think critically, and demonstrated troubleshooting and problem-solving skills
Self-motivated and willing to accept responsibilities outside of initial job description
Comfortable in a dynamic small company environment with minimal direction and able to adjust workload based upon changing priorities

Responsibilities

Provide clinical oversight and medical monitoring to one or more clinical trials
Lead project teams to design and implement clinical studies
Write protocols, investigator brochures, clinical study reports and review clinical trial documents
Conduct investigator meetings and lead site initiation visits with clinical trial investigators
Implement and deploy drug development strategic plans, develop 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
Work with internal regulatory affairs team and other ethical guidelines relevant to the pharmaceutical industry, and ensure compliance with these external guidelines
Work with internal pre-clinical scientists, translational scientists, business and commercial organizations in a cross functional manner
Work in a team environment comprising clinical operations, biomarker specialists, CROs, and regulatory affairs
Provide clinical expertise and input for regulatory filings (i.e., BLA, MAA) as well as response to questions from regulatory authorities in the context of IND submissions, clinical trial applications or filing procedures
Provide clinical guidance and work in a team environment in interactions with external stakeholders (medical experts, advisory boards, patient advocacy groups) and internal stakeholders (Research, Translational Sciences, Clinical Operations, Safety, Regulatory, Medical Affairs, and Commercial)
May present 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

Benefits

Equal employment opportunities to all employees and applicants for employment
Fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences
Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws.
Reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990
Work environment free of harassment and prohibited conduct
Promote and support individual differences and diversity of thoughts and opinion

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