Senior Medical Director, Product Safety Physician Lead

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BeOne Medicines

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 2010

🧬 Biotechnology

🏥 Healthcare

💊 Pharmaceuticals

Biotechnology • Healthcare • Pharmaceuticals

BeOne Medicines is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting the development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. With a growing global team of more than 11,000 colleagues spanning six continents, the Company is committed to radically improving access to medicines for far more patients who need them.

📋 Description

• Serve as Lead Product Safety Physician for multiple or large, complex, strategically important developmental programs • Oversee benefit/risk safety profiles of allocated products throughout the product life cycle, with a focus on early development • Identify, manage, escalate, document, and communicate safety concerns • Chair Safety Management Team meetings and represent the team at Company Safety Committee meetings • Lead safety communications, labeling amendments, Company Core Safety Information, and related regulatory materials • Lead issue management, crisis response, regulatory inquiry strategies, and responses to regulatory agencies • Provide safety leadership for regulatory meetings, safety enquiries, serious adverse events, and escalated reports • Develop safety differentiation strategies, train employees, review publications, and support in-licensing opportunities • Collaboratively author and review safety content for clinical trial protocols, investigator brochures, informed consent forms, safety reports, and monitoring plans • Review safety data, serious adverse events, abnormal laboratory results, aggregate analyses, and clinical trial safety outputs • Support clinical study reports, Summary of Clinical Safety, Integrated Summary of Safety, and 120-day updates • Represent and promote safety on product development teams and contribute to development strategy • Lead product coordination across Global Patient Safety and manage pharmacovigilance processes • Develop Product Safety Strategies, Safety Surveillance Plans, Risk Management Plans, post-approval commitments, launch plans, publication plans, and pharmacoepidemiology strategy • Evaluate processes against regulatory expectations and support inspection readiness • Train and mentor Safety Physicians and Safety Scientists • Potentially supervise Safety Scientists and Physicians depending on the program or portfolio

🎯 Requirements

• MD (or internationally recognized equivalent) plus accredited residency • 6+ years of pharmaceutical/biotechnology industry experience in Clinical Research and Clinical Development • 4+ years of experience in safety in Phase 1 and Phase 2 • Prior matrix management team experience • Prior experience as a product safety physician • Pharmaceutical product development experience, including individual study design and filing plans • Experience with global regulatory requirements for pharmacovigilance • Appropriate experience with Regulatory Agency and KOL interactions • Intermediate knowledge of working with a safety database for retrieval of safety information • Advanced knowledge of MedDRA • Advanced application capability with Excel, PowerPoint, and Word • Familiarity with data mining and exploratory analysis tools such as Spotfire • Less than 10% travel • Accredited fellowship with 1-year clinical experience with patients in a relevant therapeutic area specialty is preferred • Experience in oncology in the preapproval space is preferred

🏖️ Benefits

• Annual bonus plan eligibility for non-commercial roles • Discretionary equity awards • Voluntary participation in the Employee Stock Purchase Plan • Medical insurance • Dental insurance • Vision insurance • 401(k) • FSA/HSA • Life Insurance • Paid Time Off • Wellness benefits • Equal opportunity employer • Reasonable accommodation during the application process