Associate Director, Medical/Safety Science
About the Opportunity:
Our client, an innovative biotech company, is seeking an experienced healthcare professional for the role of Associate Director, Medical/Safety Science. This position offers the opportunity to contribute to the safety of clinical programs, leading the safety efforts across clinical development programs, and being at the forefront of drug development that impacts patients' lives.
Key Responsibilities:
Medical Safety Reviews: Conduct comprehensive medical review and assessment of safety-related data, such as SAEs, SUSARs, AESIs, and pregnancy cases in clinical trials.
Safety Data Oversight: Ensure medical accuracy in case narratives, coding, and overall safety data review, raising queries as necessary.
Clinical Trial Monitoring: Oversee safety monitoring during clinical trials, ensuring site compliance with safety protocols, and provide guidance to external partners like CROs.
Clinical Documents Contribution: Contribute to key clinical documents including protocols, study reports, Investigator Brochures, safety reports (e.g., DSURs), and informed consent forms.
Signal Detection & Analysis: Lead signal detection strategies, evaluation, and mitigation plans. Analyze aggregate safety data throughout product development.
Final Safety Deliverables: Serve as the final reviewer for safety deliverables (e.g., coding, SAE reconciliation) before database locks.
Cross-functional Collaboration: Collaborate with clinical operations, regulatory teams, and CROs for the successful execution of clinical studies.
Regulatory Queries: Respond to safety-related queries from regulatory authorities, health professionals, IRBs/IECs, and CROs.
Pharmacovigilance Leadership: Stay updated on international pharmacovigilance guidelines (FDA, EMA) and mentor drug safety staff to maintain high standards of adverse event reporting.
SOP & CAPA Creation: Contribute to creating SOPs, guidelines, and tools related to safety and perform root cause analyses with corrective and preventive actions (CAPAs).
Occasional Travel: Participate in occasional domestic and international travel (up to 20%).
What We’re Looking For:
Education: Healthcare professional degree (MD or equivalent).
Experience: 7+ years of safety/clinical development experience in the biopharma industry, including clinical trials and post-marketing safety.
Expertise: Proven knowledge in global safety reporting (e.g., IND, BLA filings), safety signal detection, and risk management.
Pharmacovigilance Knowledge: Strong understanding of pharmacovigilance principles, clinical research, and regulatory guidelines.
Hands-On Experience: Proficiency with safety databases (e.g., Argus, Aris) and coding dictionaries (e.g., MedDRA, WHODRUG).
Communication & Leadership: Excellent communication, interpersonal, and leadership skills, with the ability to mentor cross-functional teams.
Proactive Approach: A collaborative mindset and commitment to achieving excellence in safety and pharmacovigilance.
Flexibility: Willingness to travel occasionally and work onsite at least 4 days per week.
This is an exciting opportunity to shape the safety strategy of a biotech company and contribute to the development of life-changing therapies. Apply today to take the next step in your career!
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