Essential Functions and Job Responsibilities:
The Medical Director will report to the Vice President of Clinical Development. This position is responsible for planning and providing input for CymaBay's medical policies, standards, and programs as well as to design, implement and monitor clinical studies. The incumbent will also interact with biometrics personnel to plan data entry and analysis; recruit/screen/select competent investigators; plan content for investigator meetings; ensure that Good Clinical Practices (GCPs) are followed; ensure timely completion of studies; monitor data for safety and efficacy trends by reviewing clinical data; and ensure timely writing of clinical study reports upon completion or termination of studies. They will review requests of Investigational New Drugs (IND) studies and provide input for pharmacokinetics and pre-clinical studies; support development of clinical portions of INDs, New Drug Applications (NDAs) and Biological License Applications (BLAs), including protocols, investigator brochures, medical reports, efficacy and safety summaries, scientific rationales and benefit/risk ratios and provide medical input to regulatory strategy and briefing documents.
- M.D. or M.D./Ph.D.
- Minimum of 4-5 years of experience in pharmaceutical or biotechnology setting and several additional years of clinical practice
- Clinical development experience across all phases of product development and in multiple indications, to include roles in late-stage clinical trials, regulatory filings
- Experience in hepatology/gastroenterology are preferred, but clinical experience or training in cardiology, endocrinology, nephrology, rheumatology/immunology will be considered. Experience in orphan indications is considered valuable.
- Thorough knowledge of FDA regulatory requirements, as well as knowledge of ex-US regulatory processes, and ICH/GCP guidelines are essential
- Strategic thinker and creative problem-solver capable of identifying risks and risk mitigation strategies
- Possesses excellent teamwork, negotiation and influencing skills, able to work in a matrix project team setting and a proven track record establishing and achieving clear and consistent goals and objectives