Clinical Research Medical Director, Oncology – California

Clinical Research Medical Director, Oncology – California

Tanner & Associates is recruiting a Clinical Research Medical Director in Oncology for a large biotech company based in California. Please send CV to

Summary: The Company is strengthening its focus on Oncology drug development and is seeking to fill several key positions to work on various programs in early and late stage clinical development.

Key Responsibilities:

• Develops and executes medical strategies and provides scientific and medical input into the development of clinical programs.
• Leads the planning and execution of scientific deliverables outlined in the company’s Regional North American Medical Plan.
• Supports cross-functional and global collaborations to integrate broad medical, scientific and commercial input into the development program.
• Provides medical/scientific support for regional brand strategic objectives.
• Develops and manages key external and regional relationships according to the Key Opinion Leader Plan.
• Makes scientific presentations at advisory boards, key scientific meetings and external committee meetings as delegated.
• Participates in conducting safety assessments.
• Participates in interactions with regulatory agencies.
• Authors clinical study reports, publications and regulatory submissions
• Designs, prepares and initiates study protocols and other required documentation in compliance with project plans, federal regulations, GCP, and good medical practices.
• Analyzes and interprets clinical study data and prepare reports for FDA and publications.
• Serves as the primary medical monitor on assigned projects.

Qualifications:

• MD with 5 or more years of clinical research and/or basic science experience combined with clinical teaching and patient care activities involving Oncology therapeutics.
• Board certified or eligible in an appropriate medical discipline is preferred especially in Oncology.
• Familiar with investigators or institutions in Oncology.
• Clinical research experience in the biopharmaceutical industry.
• Demonstrated ability to serve as a medical expert in a complex matrix environment.

Medical/Scientific Knowledge:

• In depth understanding of the scientific method and clinical applications based on medical, scientific and practical rationale.
• Familiar with basic concepts of clinical research and clinical trial design, including biostatistics.
• Knowledge of GCP, FDA and EMEA/CHP regulations and guidelines and applicable international regulatory requirements.