EPM Scientific
Senior Medical Director of Drug Safety
EPM Scientific, Boston, Massachusetts, United States, 02228
The
Senior Medical Director of Drug Safety
is a key leadership role focusing on strategic medical safety for benefit-risk assessments of investigational products, particularly a significant biologic asset within our portfolio. This position operates in a dynamic, matrixed environment and oversees essential safety activities throughout the clinical development lifecycle, including signal detection, risk evaluation, mitigation planning, and comprehensive safety reporting. In this role, you will lead the medical review of safety documentation, such as study protocols, investigator brochures, clinical study reports, product labeling, and submissions to regulatory authorities. Additionally, you will manage a global team of dedicated pharmacovigilance experts committed to advancing clinical development safety. Key Responsibilities: Develop and maintain Development Risk Management Plans (DRMPs) to proactively address and minimize risks during clinical trials. Work collaboratively with internal and external stakeholders to monitor safety profiles, validate and assess safety signals, and propose effective risk mitigation strategies. Lead the preparation and submission of aggregate safety reports, including DSURs, PSURs, and PBRERs. Oversee the creation and upkeep of Risk Management Plans (RMPs). Contribute expert insights into safety sections of regulatory submissions and respond to safety-related inquiries from health authorities and other stakeholders. Engage with investigators and key opinion leaders (KOLs) in discussions surrounding safety topics. Ensure ongoing safety data review throughout clinical trials via structured Safety Plans and regular safety review meetings. Qualifications: M.D. is required; additional qualifications in Clinical Pharmacology, Public Health, Epidemiology, or Pharmacovigilance are preferred. A minimum of 12 years of experience in drug development, clinical safety, or pharmacovigilance within a global pharmaceutical environment. At least 3-5 years of experience managing teams of safety physicians or scientists. Comprehensive understanding of international clinical development and post-marketing safety regulations, especially concerning biologics. Demonstrated experience in interactions with global health authorities on safety matters, including RMPs and Clinical Overviews. Strong knowledge of global safety requirements throughout the product lifecycle.
Senior Medical Director of Drug Safety
is a key leadership role focusing on strategic medical safety for benefit-risk assessments of investigational products, particularly a significant biologic asset within our portfolio. This position operates in a dynamic, matrixed environment and oversees essential safety activities throughout the clinical development lifecycle, including signal detection, risk evaluation, mitigation planning, and comprehensive safety reporting. In this role, you will lead the medical review of safety documentation, such as study protocols, investigator brochures, clinical study reports, product labeling, and submissions to regulatory authorities. Additionally, you will manage a global team of dedicated pharmacovigilance experts committed to advancing clinical development safety. Key Responsibilities: Develop and maintain Development Risk Management Plans (DRMPs) to proactively address and minimize risks during clinical trials. Work collaboratively with internal and external stakeholders to monitor safety profiles, validate and assess safety signals, and propose effective risk mitigation strategies. Lead the preparation and submission of aggregate safety reports, including DSURs, PSURs, and PBRERs. Oversee the creation and upkeep of Risk Management Plans (RMPs). Contribute expert insights into safety sections of regulatory submissions and respond to safety-related inquiries from health authorities and other stakeholders. Engage with investigators and key opinion leaders (KOLs) in discussions surrounding safety topics. Ensure ongoing safety data review throughout clinical trials via structured Safety Plans and regular safety review meetings. Qualifications: M.D. is required; additional qualifications in Clinical Pharmacology, Public Health, Epidemiology, or Pharmacovigilance are preferred. A minimum of 12 years of experience in drug development, clinical safety, or pharmacovigilance within a global pharmaceutical environment. At least 3-5 years of experience managing teams of safety physicians or scientists. Comprehensive understanding of international clinical development and post-marketing safety regulations, especially concerning biologics. Demonstrated experience in interactions with global health authorities on safety matters, including RMPs and Clinical Overviews. Strong knowledge of global safety requirements throughout the product lifecycle.