Medical Safety Officer; MSO - Oncology

Overview

Johnson & Johnson is currently seeking a Director, Medical Safety Officer (MSO) - Oncology to join our team located in Horsham, PA.

The Pharmaceuticals Medical Safety Officer (MSO) has accountability for assessing the medical safety of assigned Innovative Medicine products and will strategically lead cross-functional matrix teams responsible for product safety and benefit risk oversight. The MSO represents Global Medical Safety (GMS) as the product spokesperson regarding overall benefit/risk. The MSO will oversee the safety and benefit/risk assessment of assigned products within the Oncology therapeutic area that are marketed and/or in clinical development.

In compliance with legal and regulatory requirements, the MSO will lead, when appropriate, in the design and implementation of risk mitigation strategies to ensure the safe and appropriate use of Innovative Medicine products.

• Strategically lead the Safety Management Teams (SMT) for assigned products, including safety surveillance (signal detection) and risk management activities (e.g., Risk Management Plan (RMP), Risk Evaluation and Mitigation Strategy (REMS)) and other safety-related activities such as Program Safety Analysis Plan.
• Provide medical and scientific expertise as the GMS representative on the Compound Development Team (CDT) and Clinical Teams.
• Anticipate safety concerns and influence Clinical and Medical Affairs teams to minimize/mitigate patient impact by actively participating in protocol design.
• Serve as a core contributor of safety input to regulatory and clinical documents, including:
  Risk management plans;
  Clinical Trial, EAP and IIS Protocols;
  Informed Consent Forms (ICF) with Risk Language;
  Safety Sections of Investigator’s Brochure (IB) and  /IB addenda;
  Safety sections of Clinical Study Reports (CSR);
  Integrated Safety Summary (ISS) and Summary of Clinical Safety (SCS) for NDA/BLA/MAA filings;
  Periodic Benefit Risk Evaluation Report (PBRER), Safety Update Reports (PSUR/DSUR);
  Health authority queries;
  Company Core Data Sheets (CCDS), US and EU prescribing information;
  Signal Evaluations.
• Communicate important results of medical safety and benefit/risk evaluations to the GMS Leadership Team, CMO, and Pharmaceuticals Medical Safety Council (MSC).
• Participate in meetings with Health Authorities and external key opinion leaders; provide medical safety leadership on due diligence teams for Licensing & Acquisition opportunities.
• Provide medical oversight to contractors and non-physician staff involved in preparing written safety evaluations for assigned products, including: defining the safety question; developing strategy for safety review; interpreting results; reviewing and approving medical assessment reports (e.g., ad hoc safety reports).
• Work across GMS therapeutic areas to align and improve common processes for safety data collection, assessment, and risk management; assist in creating, reviewing, and implementing SOPs, work instructions, guidelines, and tools related to safety assessment and risk management; lead or participate in department-wide initiatives.

Note: This is not an exhaustive listing of job functions. May perform other duties as assigned.

Takes a leadership role in influencing senior management and key stakeholders to achieve strategic goals. Demonstrates collaboration, negotiation, and cross-functional engagement to achieve outcomes and maintain productive relationships across departments and external partners.

• Physician (MD or equivalent), generally requires 5+ years of pharmacovigilance experience or other relevant experience (e.g., Clinical research, Medical Affairs).
• Board Certification (if US) preferred.
• Medical specialization preferred.
• Demonstrated clinical medicine capabilities with at least 1 year of clinical practice experience.
• Demonstrated knowledge of drug development principles, pharmacology, clinical trial methodology, medical monitoring, risk/benefit assessment, and global safety regulatory requirements.
• Ability to influence, negotiate, and communicate with internal and external stakeholders; experience with Health…