Proclinical is currently recruiting for a Medical Director for a leading biotechnology company located remotely. As the Medical Director, you will manage safety surveillance for assigned compounds and products.
- Manage collection, in cooperation with a PV scientist, of current data for safety signaling and identify and investigate safety signals.
- Conduct analysis of safety data.
- Ensure adequacy of recording, summarizing, and handling of adverse events for investigational and/or marketed products including decisions on seriousness, expectedness, and causality.
- Provide safety strategic leadership for clinical development programs / program teams.
- Integrate the safety scientific component to build a strategic framework for clinical development plans.
- Develop and maintain relationships with program counterparts in Clinical Development, Pre- Clinical Safety, Research, Regulatory, Clinical Operations, Clinical Pharmacology, Quantitative Sciences, Translational Sciences, Worldwide Medical.
- Ensure the accurate and timely completion and reporting of periodic and expedited safety reports, in compliance with internal timeframes and timeframes dictated by regulatory authorities.
- If applicable, manage Medical Director(s) and Associate Medical Director(s) overseeing their activities for assigned compounds/products.
Skills and Requirements:
- MD, DO, or equivalent educational experience.
- Minimum 3 years of experience in global safety lead/officer position.
- Knowledge of pre- and post- marketing US and EU regulations.
If you are having difficulty in applying or if you have any questions, please contact Mary Jacobs at (+1) 312-291-4181 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.