Director, Medical Safety Officer, Oncology

• 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/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 & Acquisition opportunities.

• Provide medical oversight to contractors and non-physician staff involved in preparing written safety evaluations for their 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.

• 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.

• Ability to lead global cross-functional teams effectively and strategically.

• Connect, collaborate, and build consensus across relevant functions.

Ability to think strategically, have a global mindset, big picture orientation, Ability to see the context of the entire situation, understand implications to the business.

• Ability to critically evaluate safety data from multiple sources (clinical trials, environment, literature, etc.), assess clinical importance and potential strategic impact of the data and present the findings clearly in both written and oral communications.

• Experience and knowledge of Good Clinical Practices and Pharmacovigilance regulatory requirements in US, the EU and globally, the conduct of clinical trials and for the appropriate contributions to regulatory filings, PV documents and risk management plans.

• Able to plan work to meet deadlines and effectively handle multiple priorities.

• Excellent verbal and written communication skills, including formal presentation skills. Written skills as evidenced by publication and journal articles are also desirable.

• Fluent in written and spoken English.

• Proficiency in Word and PowerPoint is desired.

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 Section 503 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 contact us via https://www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource.

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