The posting
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Director, Drug Safety Physician based in United States.
This is a senior medical safety leadership role within a dynamic clinical-stage biotechnology environment. You will help shape drug safety strategy across an innovative portfolio of antibody-based therapies in immunology. The role spans individual case safety review, aggregate safety monitoring, signal detection, surveillance, and benefit-risk management. You will partner with cross-functional teams to ensure safety considerations are integrated throughout clinical development. The position also provides opportunities to engage with global regulatory requirements, health authority interactions, and clinical trial documentation. You will contribute to evolving pharmacovigilance processes while helping establish consistent, high-quality approaches to medical safety review. This fully remote opportunity offers frequent in-person collaboration, professional development, and a competitive salary range of $280,000–$311,000.
Accountabilities:
- Perform triage and medical review of Individual Case Safety Reports (ICSRs), both within and outside the global safety database.
- Oversee cases and Analysis of Similar Events (AOSEs) supporting expedited safety reporting.
- Lead cross-functional medical review discussions related to ICSR assessment.
- Participate in preparing, writing, and reviewing aggregate safety reports, including DSURs.
- Review safety sections of clinical trial documents and regulatory submissions.
- Lead or contribute to scientific literature reviews and prepare written summaries supporting aggregate safety analyses.
- Participate in safety surveillance activities and evaluate emerging safety signals from multiple data sources.
- Support the assessment, management, and monitoring of identified safety signals.
- Participate in and co-present cases at Safety Management Team and Safety Review Team meetings.
- Co-lead safety surveillance and signal management meetings.
- Develop safety presentations for independent Data Monitoring Committee meetings.
- Provide medical safety input into clinical development plans, study protocols, periodic safety reports, and safety management plans.
- Provide safety strategy and execution support for benefit-risk management of assigned products.
- Contribute to responses to health authority, institutional review board, and ethics committee queries.
- Support the development of safety risk language, risk management strategies, safety table shells, and integrated safety reviews.
- Contribute to integrated safety summary documents and safety-focused publications.
- Lead epidemiology and pharmacoepidemiology projects relevant to drug safety and pharmacovigilance, including natural history, comorbidities, class effects, real-world safety, signal detection, data mining, and comparative safety research.
- Collaborate with the Medical Review Lead and other physicians to establish consistent approaches to medical review, safety presentations, and surveillance activities.
- Assist with the development and maintenance of pharmacovigilance processes, SOPs, work instructions, safety management plans, and surveillance plans.
- Identify and implement process improvements across medical review, safety surveillance, and relevant pharmacovigilance activities.
- Ensure assigned activities meet applicable global regulatory requirements and standards for quality, accuracy, and timeliness.
- Perform additional drug safety and cross-functional responsibilities as needed.
- MD or equivalent medical degree.
- 6+ years of relevant clinical development drug safety or medical review experience within the biotechnology or pharmaceutical industry.
- Experience with medical review of ICSRs and periodic safety reports.
- Experience with late-stage or clinical development programs.
- Working proficiency with the Argus global safety database and medical review activities.
- Experience in safety surveillance and signal detection.
- Strong knowledge of global pharmacovigilance regulations and requirements, including FDA and EMA expectations.
- Experience with oncology, biologics, or innovative therapeutic modalities is valuable.
- 2–3 years of medical device safety experience is strongly preferred.
- Degree or substantial working knowledge in epidemiology or pharmacoepidemiology is highly preferred, such as an MPH, MS in Epidemiology, PhD in Epidemiology, or DrPH.
- Ability to interpret complex safety data and translate findings into actionable drug development strategies.
- Strong analytical, critical-thinking, and problem-solving skills.
- Excellent written, verbal, and interpersonal communication skills.
- Ability to motivate teams and collaborate effectively across functional disciplines.
- Strong organizational skills and attention to detail.
- Ability to manage multiple priorities while maintaining quality, accuracy, and deadlines.
- Ability to work effectively in a remote environment while participating in frequent in-person meetings and collaborative discussions.
- Salary: $280,000–$311,000 annual base salary, with actual compensation determined by factors including experience, education, skills, and geographic location.
- Bonus: Performance-based bonus opportunity.
- Equity: Equity grant opportunities.
- Healthcare: Health and welfare benefits.
- Retirement: Retirement benefits.
- Paid Time Off: Unlimited PTO.
- Company Breaks: Two one-week company-wide shutdowns each year.
- Work Model: Remote working environment.
- Collaboration: Frequent in-person meetings focused on solving complex problems and strengthening professional relationships.
- Professional Development: Opportunities to expand expertise and develop professionally.
- Scientific Impact: Opportunity to contribute to the safety strategy and development of innovative therapies.
- Leadership Scope: Broad exposure to medical safety, pharmacovigilance, regulatory strategy, clinical development, and benefit-risk management.
How Jobgether works:
We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.
We appreciate your interest and wish you the best!
Why Apply Through Jobgether?
Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.
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