Director, Medical Safety Officer – Oncology

Johnson & Johnson

Director, Medical Safety Officer for Oncology at Johnson & Johnson overseeing medical safety and risk management. Collaborating with cross-functional teams to assess safety data and lead safety strategies.

Posted 7/31/2026full-timeTitusville • New Jersey, Pennsylvania • 🇺🇸 United StatesLead💰 $199,000 - $343,850 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in pharmacovigilance, clinical trial methodology, and drug development, with a strong ability to influence and communicate effectively with stakeholders. Provides medical safety leadership and oversight in evaluating drug risks and benefits, ensuring compliance with global safety regulations.

Highest-signal resume keywords

Pharmacovigilance ExperienceClinical Trial MethodologyMedical OversightRisk Management PlansHealth Authority Presentations

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Applicant Tracking System Keywords

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Hard Skills

Clinical MedicineDrug Development PrinciplesSafety AssessmentMedical MonitoringClinical ResearchPharmacologyClinical Protocol DesignSafety EvaluationBenefit/Risk ManagementRegulatory Compliance

Soft Skills

InfluencingNegotiatingCommunicating

Certifications & Qualifications

Physician (MD or Equivalent)Board Certified/Board Eligible

Industry Keywords

PharmacovigilanceClinical TrialsMedical AffairsSafety Management TeamsCompound Development TeamInformed Consent FormsInvestigator’s BrochureClinical Study ReportsPeriodic Safety Update ReportHealth Authority Queries

About the role

Key responsibilities & impact

Strategically lead the Safety Management Teams (SMT) for assigned products.
Provide medical and scientific expertise as the GMS representative on the Compound Development Team (CDT) and Clinical Teams.
Anticipate safety concerns and influence other relevant functions including Clinical teams to minimize/mitigate patient impact by active participation in the design of the clinical protocols.
Be an active partner and core contributor of safety input to key regulatory or clinical documents including: Risk management plans, Safety development plan, Clinical Trial Protocols, Informed Consent Forms (ICF), Safety Sections of Investigator’s Brochure (IB) and IB addenda, Clinical Study Reports (CSR), Annual Safety Reports (ASR), Integrated Safety Summary (ISS) and Summary of Clinical Safety (SCS) for NDA/BLA/MAA filings, Periodic Benefit Risk Evaluation Report (PBRER)/Periodic Safety Update Report (PSUR), Health authority queries, Core Data Sheets (CDS).
Effectively communicate important results of medical safety and benefit/risk management evaluations, when necessary, to the GMS Leadership Team, CMO, and the Medical Safety Council (MSC).
Actively participate and contribute to meetings with Health Authorities and external key opinion leaders.
Provide medical safety leadership on due diligence teams to evaluate Licensing & Acquisition opportunities.
Provide medical oversight to contractors and non-physician staff involved in preparing written safety evaluations for their assigned products.

Requirements

What you’ll need

Physician (MD or equivalent) with 2-5 years of pharmacovigilance (PV) experience or other relevant experience (e.g., Clinical research, Medical Affairs, clinical) required.
Board Certified/Board Eligible/equivalent preferred.
Medical specialization preferred.
Demonstrated skills in clinical medicine with at least 1 year of clinical practice experience.
Demonstrated knowledge of principles of drug development, pharmacology, clinical trial methodology and design, medical monitoring of trials, assessment of drug risks and benefits, and safety assessment of drugs both on the market and in development and global safety regulations highly preferred.
Ability to influence, negotiate and communicate with both internal and external stakeholders.
Experience with Health Authority presentations is preferred.

Benefits

Comp & perks

Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year