What are the responsibilities and job description for the Associate Director, Medical/Safety Science position at Enigma Search?
About the job Associate Director, Medical / Safety Science
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 Were Looking For :
Our ideal candidate has :
The estimated base salary range for this role is $224,000 - $235,000. Actual pay will be based on a number of factors including experience and qualifications. This position is also eligible for two annual cash bonuses.
Salary : $224,000 - $235,000
