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Director, Medical Safety Officer – Oncology
Johnson & Johnson. Assess medical safety of assigned products and strategically lead cross-functional product safety and benefit-risk teams .
About the role
Key responsibilities & impact- Assess medical safety of assigned products and strategically lead cross-functional product safety and benefit-risk teams
- Represent Global Medical Safety as product spokesperson for overall benefit/risk
- Report to the Product Safety Head, Cellular Therapy, Hematology and oversee assigned Hematology products
- Conduct proactive and timely safety-data assessments to characterize safety profiles and benefit-risk
- Communicate risks and benefit-risk changes to safety leadership, senior management, health authorities, prescribers, and patients
- Lead design and implementation of risk-mitigation strategies
- Lead Safety Management Teams, including safety surveillance, signal detection, risk management plans, and REMS activities
- Provide medical and scientific expertise on Compound Development and Clinical Teams
- Influence clinical protocol design to minimize or mitigate patient impact
- Contribute safety input to regulatory and clinical documents, filings, reports, protocols, and health-authority queries
- Communicate medical safety and benefit-risk evaluation results to leadership and councils
- Participate in Health Authority and key opinion leader meetings
- Provide medical safety leadership for licensing and acquisition due diligence
- Provide medical oversight to contractors and non-physician staff preparing safety evaluations
- Review and approve medical assessment reports
- Align and improve safety processes across therapeutic areas and clinical teams
- Assist with SOPs, work instructions, guidelines, and safety tools
- Lead or participate in department-wide initiatives
Requirements
What you’ll need- Physician (MD or equivalent) with 2–5 years of pharmacovigilance or other relevant experience required
- At least 1 year of clinical practice experience
- Board Certified/Board Eligible/equivalent preferred
- Medical specialization preferred
- Knowledge of drug development, pharmacology, clinical trial methodology and design, medical monitoring, drug risk/benefit assessment, and safety assessment
- Knowledge of Good Clinical Practices and pharmacovigilance regulatory requirements in the US, EU, and globally
- Experience with Health Authority presentations preferred
- Ability to lead global cross-functional teams
- Ability to collaborate and build consensus across functions
- Ability to critically evaluate safety data from clinical trials, environment, literature, and other sources
- Ability to plan work, meet deadlines, and handle multiple priorities
- Excellent verbal, written, and formal presentation skills
- Fluent in written and spoken English
- Proficiency in Word and PowerPoint desired
Benefits
Comp & perks- Inclusive work environment
- Equal opportunity employment
- Inclusive interview process and disability accommodations