Senior Medical Director, Global Drug Safety

2 weeks ago

Oklahoma City, United States Scienta Full time

Senior Medical Director, Drug Safety

Company –

Global NASDAQ Biotech, Gene Therapy

Location –

Massachusetts

About: Our client is a leading biotechnology company specializing in the development of gene therapy. Their focus is on creating innovative in vivo treatments that directly modify genes within the human body to combat severe and life-threatening diseases. The company is renowned for its commitment to scientific excellence, ethical standards, and patient safety. Their work represents a significant advancement in the field of genetic medicine, offering new hope for treating complex genetic disorders.

Role Overview: The Senior Medical Director is responsible for global strategic and operational oversight of safety surveillance and risk management activities within a specific therapeutic area. This role involves compliance with international legislation and regulations. The incumbent will define and execute the safety surveillance and risk management strategy, leading a team of medical professionals and scientists. This team is responsible for identifying, analyzing, assessing, communicating, and managing safety issues for a range of products throughout their lifecycles. The role requires providing medical and drug safety expertise for decision-making based on complex risk/benefit evaluations, data interpretation from clinical trials or pharmacoepidemiological studies, and risk assessment and mitigation strategies.

Responsibilities: Leadership and oversight of safety surveillance, benefit-risk assessment, and risk management for the product portfolio, covering all stages from pre-approval to post-approval. Directing a team of Medical Directors and Safety Scientists in resolving safety signals and communicating risk management plans. Providing expertise in medical and pharmacovigilance matters to guide decision-making processes. Collaborating with internal departments and affiliates to deliver comprehensive pharmacovigilance and risk management support. Leading product safety management teams in decision-making and developing strategic steps. Overseeing high-priority safety and regulatory projects. Ensuring timely safety surveillance, detection of new safety issues, and communication by the team. Managing the generation of regulatory reports and risk management documents.

Qualifications: MD or equivalent, Board certification preferred. Excellent problem-solving skills and ability to handle complex, overlapping tasks. Knowledge of industry-specific safety regulations and standards. 5-7 years in safety and risk management in the pharmaceutical, and biotech. Experience in Immunology/oncology. Strong communication skills, independent judgment, and project management abilities. Gene Therapy experience preferred.

Please apply if you believe you have the skills, experience, and passion that align with this role. We look forward to introducing our client to their future team member.

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