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

5+ years

Not Disclosed

Remote, USA

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.

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

Job Description

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