The Medical Director manages the clinical development of drug candidates, including phase I-IV studies and across multiple therapeutic areas. The Medical Director will have a strong understanding of all phases of pharmaceutical drug product development, including clinical trial management, IND and NDA submissions, medical monitoring, GCP principles, and will have extensive experience in collaboration with Clinical Operations, Research and Clinical Pharmacology, Medical Affairs, Regulatory Affairs and other key stakeholders.
- Develop protocols to execute clinical development strategies
- Work cooperatively with Clinical Operations and designated CROs to execute the programs (e.g. lead study start up and database lock, performs data and coding reviews; draft/present clinical slides for Investigators Meeting, Advisory Boards and therapeutic/monitor training; review draft CRFs, etc.)
- Provides clinical leadership and medical strategic input for all clinical deliverables in the assigned project or section of a clinical program if applicable.
- Clinical deliverables may include clinical sections of individual protocols, clinical data review, program specific standards, clinical components of regulatory documents/registration dossiers, and publications
- Leads development of clinical sections of trial and program level regulatory documents (e.g., Investigator’s Brochures, briefing books, safety updates, submission dossiers, and responses to Health Authorities) and supports all other Regulatory activities and NDA related questions
- Drives execution of the section of the clinical program in partnership with other line functions (regulatory, clin ops)
- Act as study medical monitor ensuring overall safety of the molecule for the assigned section, and supports overall program safety reporting (e.g., Periodic Safety Update Reports (PSURs), Drug Safety Update Reports (DSURs), and other safety related documents) in collaboration with Patient Safety
- Work with academic leaders/advisers to develop clinical strategy
- Other duties commensurate with position as assigned
- Ability to travel required
- M.D. degree with a minimum of 5 years industry experience, or comparable experience in the management and execution of phase I-III trials with credible compounds/established companies
- Demonstrated ability to independently evaluate, interpret and present complex scientific data
- Demonstrated ability to critically evaluate complex drug development programs
- Proven leadership and management experience
- Demonstrated ability to work within a multi-disciplinary team of peers and outside experts