Senior Medical Director - Clinical Development
Proclinical is currently recruiting for a Senior Medical Director of Clinical Development with a leading biotechnology company located in Gaithersburg, MD. As the Senior Medical Director, you will be primarily responsible for developing and executing an integrated clinical trial program including protocol design and medical oversight of ongoing studies.
- Lead the clinical development program.
- Direct human clinical trials, phases I-IV, for lead candidate in development, helping to ensure all clinical development milestones are met.
- Participate in medical review of adverse event reports and monitoring of incoming safety data in conjunction with product safety/pharmacovigilance, including evaluating and escalating safety signals.
- Coordinate and develop information for reports submitted to FDA, CDC, WHO, or other government, regulatory, or partner agencies.
- Present to various external stakeholders - regulators, governing/harmonization bodies, principle investigators, scientific conference attendees, advisors and opinion leaders.
- Plan, review and edit Clinical Study Reports.
- Provide input on the design of preclinical studies supporting clinical strategy.
- Manage key external technology partnerships.
Skills and Requirements:
- MD with vaccine product development and experience across stages of clinical development.
- Minimum of 5 years' experience in pharmaceutical, biologics, or biotech R&D environment, or in a research environment involving the collection and analysis of human data in the area of infectious diseases.
- Functional knowledge of concepts in vaccine immunology and vaccine development, preferably with experience in design and conduct of clinical trials.
- Knowledge of clinical trial conduct to support operational needs for planning and executing clinical trials, including adherence to protocols, safety reviews, assay development, training, and clinical document review.
- Working knowledge of clinical development pathways for vaccines in the US and EMA.
- Self-starter who will move forward with key initiatives without being prompted, able to perform a myriad of tasks needed to support the clinical development program.
- Evidence of effective leadership skills.
- Good verbal and written communication skills.
- Ability to work cross-functionally.
If you are having difficulty in applying or if you have any questions, please contact James Stevens at (+1) 646-693-0610 or firstname.lastname@example.org
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.