Medical Director/Senior Medical Director
Reporting to the VP, Clinical Development, the Medical Director manages the day-to-day activities of clinical development of drug candidates, from early to late-stage, and across multiple therapeutic areas. The Medical Director will assume a hands-on role in the planning, implementation, conduct and oversight of clinical trials, in close partnership with the Clinical Operations group.
The candidate must have relevant and direct experience in clinical development within the pharmaceutical or biotech industry (at least 5 years preferred). Strong clinical background, high scientific interest and effective communication skills are required. The Medical Director will be responsible for ensuring proper clinical conduct of study protocols in compliance with GCP and local/global trial regulations, oversee and provide clinical guidance to CRO medical monitors (and study investigators, as needed) and study team, lead development of study protocols, protocol amendments and clinical study reports. The Medical Monitor will work in close collaboration with Clinical Operations and Project Management to achieve clinical development goals and deliverables.
- Develop study protocols and obtain cross-functional input to execute on clinical development strategies
- Work in close collaboration with Clinical Operations and designated CROs to ensure quality and timely execution of the clinical programs (i.e.: study startup, conduct and database lock activities; medical monitor training and oversight; safety monitoring plans; protocol deviation lists; data and AE codingreviews; statistical analysis plans; develop/present clinical slides at Investigators Meetings)
- Write/review/edit clinical study reports, investigator brochures and clinical aspects of regulatory submissions and clinical trial applications; supports all other regulatory activities, including protocol-related questions from health authorities
- Ensure that the Clinical Development department is working in lockstep with Clinical Operations and Project Management and along with Regulatory Affairs, Drug Safety/Pharmacovigilance, Clinical Pharmacology and Medical Affairs, as appropriate, for effective and high-quality execution of various programs
- Domestic and global travel may be required
- M.D. degree with a minimum of 5 years industry experience, in the management and execution of Phase 1-3 trials; clinical pharmacology background a plus
- Experience in fibrosis and/or rare diseases is a definite plus
- Sound and comprehensive knowledge of the drug development process, trial management and vendor oversight, safety reporting, MedDRA and WHODrug dictionaries, study methodology, data reviews, statistical analysis plans and local and global clinical trial regulations
- High scientific acumen and demonstrated ability to independently evaluate, interpret and present complex scientific data
- Sound understanding of statistics and demonstrated ability to critically evaluate complex drug development programs
- Demonstrated ability to work collaboratively with a multi-disciplinary team of peers, consultants and vendors
- Excellent communication skills including written, oral, and presentation skills.Evidence of publication of original scientific papers in translational and/or clinical research will be valued
- Able to work effectively in a small dynamic organization; ability to assume multiple roles and responsibilities and meet stretch goals
- Strong people management skills that focus on teamwork and building alliances; ability to resolve conflicts and to negotiate effectively
- Positive approach to work and ability to motivate team members to meet timelines and project goals is required
- Ability to develop strong relationships with study investigators and key opinion leaders within therapeutic area.