Job Description

About the Opportunity:

Are you an experienced healthcare professional with a passion for ensuring the safety of clinical programs and delivering life-changing therapies? Our client, an innovative biotech company, is seeking an Associate Director, Medical/Safety Science to lead and manage medical safety efforts across clinical development programs. This is an exciting opportunity to be at the forefront of drug development, contributing to groundbreaking science and improving patients' lives.

Key Responsibilities:

As the Associate Director, Medical/Safety Science, you will:

• Conduct comprehensive medical review and assessment of all safety-related data (e.g., SAEs, SUSARs, AESIs, pregnancy cases) for clinical trials.
• Ensure medical accuracy in case narratives, coding, and overall review of safety data, raising queries as necessary.
• Oversee clinical trial safety monitoring, ensuring site compliance with safety protocols, and providing guidance to external partners like CROs.
• Contribute to critical clinical documents such as clinical protocols, study reports, Investigator Brochures, safety reports (e.g., DSURs), and informed consent forms.
• Analyze aggregate safety data throughout product development and lead signal evaluation planning for new and ongoing clinical programs.
• Implement innovative signal detection strategies and manage safety signal tracking, evaluation, and mitigation plans.
• Serve as the final reviewer for safety deliverables (e.g., coding, SAE reconciliation) prior to database locks.
• Collaborate with cross-functional teams, including clinical operations, regulatory, and CROs, to ensure the successful execution of clinical studies.
• Respond to safety-related queries from regulatory authorities, health professionals, IRBs/IECs, and CROs.
• Stay current with international pharmacovigilance guidelines (FDA, EMA) and mentor drug safety staff to uphold high-quality adverse event reporting standards.
• Contribute to the creation and implementation of SOPs, guidelines, and other tools related to safety.
• Perform root cause analyses and implement corrective and preventive actions (CAPAs) as needed.
• Participate in occasional domestic and international travel (up to 20%).

What We’re Looking For:

Our ideal candidate has:

• A healthcare professional degree (MD or equivalent).
• 7+ years of safety/clinical development experience in the biopharma industry, including both clinical trials and post-marketing safety.
• Proven expertise in global safety reporting requirements (IND, BLA filings), safety signal detection, and risk management activities.
• A strong understanding of pharmacovigilance principles, clinical research, and regulatory guidelines.
• Hands-on experience with safety databases (e.g., Argus, Aris) and coding dictionaries (e.g., MedDRA, WHODRUG).
• Excellent communication and interpersonal skills, with the ability to lead and mentor cross-functional teams.
• A proactive, collaborative approach and commitment to achieving excellence in safety and pharmacovigilance.
• Flexibility for occasional travel and a willingness to work onsite at least 4 days per week.

Job Tags

Similar Jobs