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. Requirements 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. Core Competencies Demonstrates expertise in safety management, risk assessment, and pharmacovigilance, with a strong ability to communicate and collaborate with clinical teams and regulatory authorities. Possesses a solid foundation in drug development principles and clinical trial methodologies. Highest-signal resume keywords Pharmacovigilance Experience Risk Management Plan (RMP) Clinical Trial Protocols Medical Oversight Health Authority Presentations ATS Optimization Keywords Hard Skills Safety Surveillance Signal Detection Risk Evaluation and Mitigation Strategy (REMS) Clinical Study Reports (CSR) Informed Consent Forms (ICF) Integrated Safety Summary (ISS) Periodic Benefit Risk Evaluation Report (PBRER) Drug Development Principles Clinical Trial Methodology Medical Monitoring Soft Skills Influencing Stakeholders Negotiation Communication Certifications & Qualifications Board Certified Board Eligible Industry Keywords Safety Management Teams (SMT) Compound Development Team (CDT) Medical Safety Council (MSC) Core Data Sheets (CDS) Annual Safety Reports (ASR) Global Safety Regulations #J-18808-Ljbffr Jobtailor