Medical Safety Officer - Solid Tumors Oncology

Medical Safety Officer (MSO) Position within Johnson & Johnson’s Global Medical Safety (GMS) organization. Reports to the Therapeutic Area Safety Head. Responsible for assessing the medical safety of Innovative Medicine products and strategically leading cross‑functional matrix teams for product safety and benefit‑risk oversight. Essential Job Duties and Responsibilities Strategically lead the Safety Management Teams (SMT) for assigned products. SMT responsibilities include safety surveillance (including signal detection) and risk management activities [including Risk Management Plan (RMP) and Risk Evaluation and Mitigation Strategy (REMS)], as well as other activities related to managing the safety profile of 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 or 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 (verbally and in writing) 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 and acquisition opportunities. Provide medical oversight to contractors and non‑physician staff involved in preparing written safety evaluations for assigned products. This will include: Defining the safety question or issue requiring medical safety assessment. Developing the strategy for the safety review and analysis. Interpreting results and determining the medical importance of a question or issue. Reviewing and approving (i.e., signatory) medical assessment reports (e.g., ad hoc safety reports). Work across the GMS TAs to align and improve common processes, including providing strong leadership and a harmonized approach across clinical teams for safety data collection, assessment, and safety‑related processes and issues. Assist in the creation, review, and implementation of new SOPs, Work Instructions, guidelines, documents, and other tools pertaining to safety assessment and risk management. Lead or actively participate in department‑wide initiatives. Perform delegated responsibilities for other MSOs and/or SMT Chairs. Minimum Qualifications Physician (MD or equivalent) with 2–5 years of pharmacovigilance (PV) experience or other relevant experience (e.g., clinical research, medical affairs, clinical). Board Certified, Board Eligible, or 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. Ability to influence, negotiate, and communicate with both internal and external stakeholders. Experience with Health Authority presentations preferred. Required Technical Knowledge and Skills Ability to lead global cross‑functional teams effectively and strategically. Connect, collaborate, and build consensus across relevant functions. Strategic thinking with a global mindset and big‑picture orientation. Critical evaluation of safety data from multiple sources (clinical trials, environment, literature, etc.), assess clinical importance and potential strategic impact of data, and present findings clearly in written and oral communications. Knowledge of Good Clinical Practices and pharmacovigilance regulatory requirements in the U.S., EU, and globally, including conduct of clinical trials and contributions to regulatory filings, PV documents, and risk‑management plans. Ability to plan work to meet deadlines and handle multiple priorities. Excellent verbal and written communication skills, including formal presentation skills. Fluent in written and spoken English. Proficiency in Word and PowerPoint preferred. Preferred Skills Clinical Operations Compliance Management Compliance Risk Consulting Design Mindset Developing Others Leadership Medicines and Device Development and Regulation Operational Excellence Quality Control (QC) Research Ethics Risk Management Safety Investigations Safety‑Oriented Serious Adverse Event Reporting Standard Operating Procedure (SOP) Succession Planning Surveillance Compensation and Benefits Anticipated base pay range: $199,000 – $343,850. Eligible for an annual performance bonus and long‑term incentive program. Eligible for medical, dental, vision, life insurance, short‑ and long‑term disability, business accident insurance, and group legal insurance. Eligible for the company’s 401(k) and pension plans. Vacation: up to 120 hours per calendar year Sick time: up to 40 hours per calendar year (up to 56 hours in Washington State) Holiday pay: up to 13 days per calendar year, including floating holidays Work, Personal, and Family Time: up to 40 hours per calendar year Equal Opportunity Employer Statement Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (View email address on click.appcast.io) or contact AskGS to be directed to your accommodation resource. #J-18808-Ljbffr 6084-Janssen Research & Development, LLC Legal Entity