Senior Director, Patient Safety Physician Line Manager – Oncology

Role Overview

The Global Safety Program Lead is responsible for the safety strategy, oversight, and delivery of assigned assets, reporting to the Global Safety Head. This role involves working closely with safety physicians and scientists to develop and implement safety strategies at both the asset and study levels. The Lead will act strategically to optimize benefit-risk profiles, maintain a competitive advantage, and ensure compliance with global safety regulations. Additionally, this role includes managing a team of safety physicians and scientists and may require deputizing for the Global Safety Head.

The Global Safety Program Lead operates with the highest ethical, quality, and compliance standards in accordance with global and local regulations, GxP practices, and company procedures.

Key Responsibilities

Safety Leadership & Strategy

• Serve as the primary scientific and clinical safety expert for assigned assets or indications.
• Lead the Safety & Strategy Management Team (SSaMT) and Safety Surveillance Team to ensure high-quality safety oversight.
• Align safety strategies with the Global Project Team (GPT) and therapeutic area objectives.
• Define safety Target Product Profiles (TPP), Go/No-Go criteria, safety messaging, and toxicity management guidelines.
• Represent Global Patient Safety in governance meetings, regulatory forums, and advisory boards.
• Oversee key safety deliverables, including Risk Management Plans (RMPs) and Periodic Safety Reports (PSRs), ensuring compliance with pharmacovigilance regulations.
• Provide strategic safety input into study design, monitoring, and data interpretation across clinical development and post-marketing surveillance.
• Drive proactive risk mitigation and troubleshooting within the safety domain.
• Lead and mentor a team of safety physicians and scientists, fostering a culture of cross-functional collaboration and excellence.

Scientific & Clinical Safety Expertise

• Stay updated on relevant scientific literature and safety trends, effectively communicating key insights.
• Ensure proper data collection and interpretation to assess risks and inform global labeling decisions.
• Conduct robust safety data analyses to support clinical development and regulatory submissions.
• Act as a scientific and clinical safety resource for product teams, providing expert guidance on safety data interpretation.

Qualifications & Experience

Required:

• Medical degree (MD) or equivalent in biomedicine or science.
• At least 5 years of experience in clinical safety, pharmacovigilance, or risk management within the pharmaceutical, biotech, CRO industry, academia, or health authorities.
• Proven track record in clinical safety strategy and risk management.
• Strong ability to collaborate in a matrixed environment and influence key stakeholders (Clinical Development, Medical Affairs, Regulatory Affairs).
• Deep understanding of global pharmacovigilance regulations and pre/post-launch safety requirements.
• Experience with global regulatory submissions and interactions with major regulatory agencies.
• Demonstrated leadership in mentoring and coaching safety teams.
• Ability to travel domestically and internationally.
• Strong presentation skills, with experience communicating complex topics to senior leadership.

Preferred:

• PhD or other advanced degree in a scientific discipline.
• Industry conference speaking experience.
• Expertise in a specific disease area relevant to the company’s portfolio.

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