Senior Medical Director, Product Safety Physician Lead
New
J
JobgetherBiotechnology / Pharmaceutical
Fully remote opportunity within the United States.Full-TimeSenior
SalaryAnnual base salary: $298,200–$368,200
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Job Details
- Experience
- At least 6 years of pharmaceutical or biotechnology industry experience spanning Clinical Research and/or Clinical Development, including 4+ years of safety experience in Phase 1 and Phase 2 development.
- Required Skills
- Microsoft ExcelPowerPointRisk Management
Requirements
- MD or internationally recognized equivalent with an accredited residency.
- At least 6 years of pharmaceutical or biotechnology industry experience spanning Clinical Research and/or Clinical Development.
- 4+ years of safety experience in Phase 1 and Phase 2 development.
- Prior experience serving as a Product Safety Physician with responsibility for developmental product safety and risk management.
- Strong knowledge of global pharmacovigilance requirements, safety regulations, and applicable ICH standards.
- Experience interacting with Regulatory Agencies and Key Opinion Leaders.
- Advanced knowledge of MedDRA.
- Advanced proficiency with Microsoft Office (Excel, PowerPoint, Word).
- Oncology experience (preferred).
- Accredited fellowship and at least one year of clinical patient experience (preferred).
- Familiarity with data-mining and exploratory analysis tools such as Spotfire (preferred).
- Ability to travel occasionally (less than 10%).
Responsibilities
- Serve as the Product Safety Physician Lead for multiple or large, complex, and strategically important developmental programs.
- Lead benefit-risk oversight throughout the product lifecycle, with emphasis on early-stage development.
- Chair Safety Management Team meetings and represent product safety considerations to senior governance bodies.
- Lead product safety issue management, including risk assessment, response strategy, and regulatory inquiries.
- Collaborate on clinical trial design, documentation, and safety monitoring plans.
- Lead interpretation of ongoing clinical safety data and provide medical review for serious adverse events.
- Provide safety input into Clinical Study Reports, DSURs, and regulatory filing activities.
- Mentor and develop Safety Physicians and Safety Scientists.
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