Senior Medical Director, Clinical Development

Location: San Francisco, USA

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​My client is an innovative clinical-stage firm experiencing great success in becoming a global leader in development of medicines for cancer patients through combination therapies. With an existing pipeline both novel and targeted developmental-stage assets, they require developmental support and are seeking a Senior Medical Director of Clinical Development to report to the CMO in the greater San Francisco Bay area. You will be responsible for all aspects of development of Phase 1-3 clinical trials and will work closely with the Clinical Operations team. This will be a highly strategic and hands-on role, and prior leadership experience as well as a strong background in oncology clinical development across all phases is required.

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Responsibilities:

• Manage the process, and at times act as medical monitor, for the company’s clinical studies effort to ensure success, scientific integrity/accuracy and ethical conduct of clinical protocols, investigator brochures, FDA/Health Authority review, and clinical study reports.

• Medical resource for design and interpretation of clinical and preclinical programs to support existing and new development candidates.

• In conjunction with clinical development staff, direct and oversee clinical studies, including clinical strategy and design, protocol writing, Institutional Review Board/Ethics Committee applications, training, monitoring, documentation, and data analysis.

• Review and approve procedures for the design and implementation of clinical protocols, data collection systems and final reports.

• Ensures clinical studies are appropriately designed, effectively executed and monitored.

• Provide safety surveillance guidance and acts as a medical monitor

• Manage outside consultants/vendors to ensure data is accurately collected and analyzed in a cost-effective fashion.

• Take a leadership role in proposal development to identify effective clinical and regulatory implementation strategies

• Conduct literature reviews, prepare summaries support clinical development programs

• Prepare manuscripts, abstracts and presentations for scientific meetings.

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Qualifications:

• M.D. required. Board certification or eligibility in Oncology preferred.

• Strong Oncology experience

• At least 3 years of clinical development experience in the biopharma industry

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Please apply with an updated CV & direct any questions to lucy.psaltis@rbwconsulting.com

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Salary: On application