Proclinical is currently recruiting for a Medical Director with a biotechnology company located in Boston, MA. The successful candidate will demonstrate the flexibility and capability to function at a high level across multiple disease areas (primarily, neurodegenerative diseases: Parkinson's disease and amyotrophic lateral sclerosis) and will be comfortable working in an entrepreneurial environment to advance the safety and biological understanding of compounds through life cycle.
- Responsible for global pharmacovigilance for investigational and marketed products including review and analysis of safety data, the identification and investigation of safety signals, management of benefit-risk profile for assigned compounds and products
- Responsible for keeping upper management informed of safety issues and may work with clinical programs as medical advisor
- Manage safety surveillance for assigned compounds / 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 PharmD
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Sarah Beshara at 267-477-3355 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
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.