Medical Safety Director, Clinical Scientist

About the role

The Medical Safety Director, Clinical Scientist provides expert clinical science support to product teams, ensuring that safety, labeling, and regulatory deliverables are scientifically robust and compliant. Working closely with the Global Clinical Science Lead, the role influences benefit‑risk assessments and contributes to timely decision‑making.

Key responsibilities

• Represent Clinical Science in product‑team meetings, including Labeling Working Groups (LWG) and Safety Management Teams (SMT).
• Gather and provide information to the Global Clinical Science Lead for safety and labeling activities.
• Review draft regulatory documents (PBRER/PSUR, CCDS/CCSI, US Annual Report, Safety Validation and Evaluation Reports) from a clinical perspective and flag critical issues.
• Support CCDS updates, emerging safety topics, issue‑resolution activities, and regulatory or market queries.
• Collaborate with cross‑functional teams to ensure scientific accuracy, consistency, and compliance of safety and labeling documentation.

Required profile

• Advanced life‑sciences degree (MD, PharmD, PhD or equivalent) with strong clinical science expertise.
• Proven experience supporting regulatory and pharmacovigilance deliverables such as PBRER/PSUR, CCDS/CCSI, and US Annual Reports.
• Hands‑on experience reviewing clinical sections of safety, regulatory, and labeling documents.
• Deep knowledge of drug safety, pharmacovigilance, risk management, and global labeling processes.
• Experience working in cross‑functional product teams, Safety Management Teams, and Labeling Working Groups.
• Excellent scientific communication and stakeholder‑management skills in a global matrix environment.

Required skills

What we offer

• Opportunity to work with a leading global provider of clinical research services and healthcare intelligence.
• Collaborative, matrixed environment with exposure to innovative medical treatments.