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Sr. Medical Director - Drug Safety And Pharmacovigilance (Remote)

Legend Biotech Us
Legend Biotech US
5+ years
Not Disclosed
10 Nov. 18, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Sr. Medical Director - Drug Safety & Pharmacovigilance (Remote)
Location: United States

Company Overview
Legend Biotech is a global biotechnology leader focused on advancing therapies for life-threatening diseases. Based in Somerset, New Jersey, we specialize in innovative cell therapies across various platforms, including autologous and allogenic chimeric antigen receptor T-cell (CAR-T) and natural killer (NK) cell-based immunotherapies. Our strategic collaboration with Janssen (Johnson & Johnson) aims to develop and commercialize cilta-cel for treating multiple myeloma.

Position Overview
We are seeking a Sr. Medical Director, Drug Safety & Pharmacovigilance to join our Clinical Development Team. This pivotal role will provide safety strategy and expertise, guiding clinical development projects while ensuring compliance with global regulatory standards. You will play a critical role in risk management, signal detection, and managing the safety profile of our compounds. The position involves cross-functional collaboration and ensuring alignment across studies to meet project goals within set timelines.

Key Responsibilities

  • Lead pharmacovigilance strategy and activities to align with corporate clinical and commercial objectives.
  • Conduct signal detection, monitoring, and safety data interpretation to manage safety risks.
  • Lead Safety Monitoring Team (SMT) meetings to evaluate the benefit-risk profile of compounds.
  • Perform medical safety reviews and causality assessments across multiple data sources (preclinical, clinical, post-marketing).
  • Provide medical input into critical clinical development documents (INDs, NDA/BLA, protocols, ICFs).
  • Oversee Urgent Safety Measures and aggregate reports for assigned projects.
  • Engage with regulatory authorities on safety topics, ensuring timely and accurate clinical content for inquiries.
  • Manage and provide leadership to CRO teams, ensuring effective service delivery and vendor oversight.
  • Develop and manage the drug safety budget, resources, and expenses.
  • Support internal and external meetings, including governance and regulatory authority sessions.
  • Identify project risks, develop mitigation strategies, and provide transparent updates to senior leadership.
  • Lead team coaching and performance management activities to foster high performance.
  • Ensure adherence to corporate policies and healthcare regulations.
  • Participate in process improvements and departmental training initiatives.

Requirements

  • MD, MBBS, MD-PhD, or equivalent medical degree.
  • Minimum 5 years of experience in Drug Safety & Pharmacovigilance.
  • Strong knowledge of pharmacovigilance regulations in the US and EU.
  • Experience in supporting drug safety in clinical registrational studies.
  • Expertise in drug development from discovery through registration and post-marketing surveillance.
  • Proven leadership experience in a matrix environment, managing teams and ensuring goal achievement.
  • Experience in IND, NDA/BLA filings and regulatory interactions is highly desirable.
  • Experience in biotech is a plus but not required.

Legend Biotech is an Equal Opportunity Employer
We are committed to creating a diverse, inclusive workforce and ensuring equal employment opportunity regardless of race, color, religion, sex, sexual orientation, gender identity, age, disability, national origin, or any other characteristic protected by law. We maintain a drug-free workplace.