Director Safety Physician

Medical Safety Physician (MSP)

Responsibilities

• Provide medical safety expertise to one or more study management teams in oncology.
• Ensure patient safety throughout the clinical trial process with assigned Safety Scientists.
• Contribute to clinical trial protocols; train investigators.
• Assess safety data (adverse events of special interest and serious adverse events), determine follow-up actions, and conduct safety signal detection/evaluation.
• Ensure compliance with Good Clinical Practice (GCP) and regulatory reporting requirements; contribute to safety documents (DSURs, reference safety information updates, Investigator Brochures, Clinical Trial Reports).
• Accountable for quality performance of one or more Safety Management Teams (SMTs).
• Oversee safety monitoring, signal management, and benefit-risk of assigned products across the product life cycle.
• Lead escalation, management, and communication of safety inquiries/concerns.
• Formulate and drive optimal safety strategy for oncology programs at the portfolio level.
• Present and interact with Regulatory Authorities on safety matters.
• Oversee quality of safety content in clinical/regulatory documents.
• Participate in due diligence for licensing/acquisition initiatives.
• Represent Medical Safety Pharmacovigilance (MSPv) in alliance management and collaborative development projects.
• Serve as portfolio-level safety subject matter expert; arbiter for safety-related issues.
• Ensure activities comply with applicable law and internal/external quality standards; train and mentor Safety Physicians and Safety Scientists.

Qualifications

• Medical Degree (MD or internationally recognized equivalent); MD/PhD and/or certified training in a relevant discipline is a plus.
• Extensive drug safety/pharmacovigilance experience in biopharma/biotech, including innovative drug development, BLA/MAA submissions, and advisory committee experience (preferably immuno-oncology/inflammation).
• Experience working with Regulatory Agencies on development strategies for innovative oncology products (especially US).
• Demonstrated results in matrix/multidisciplinary teams; GCP implementation and safety reporting compliant with global/local regulations.

Benefits and Remuneration (US)

• Expected pay range: $168,100/year to $268,700/year + benefits, annual bonus, and equity.