Medical Director, Pharmacovigilance, Gene therapy & Cellular Immuno-oncology
Join a rapidly growing, clinical stage biotech company at the forefront of gene therapy. As a drug safety physician working on bluebird's investigational and (future) marketed products, this role is an exciting opportunity to become a part of an expert team working in gene therapy and cellular immuno-oncology drug safety. This opportunity is ideal for a candidate with pharmacovigilance industry experience or an academic physician with extensive clinical trial experience. The mandate of this role is to support bluebird's clinical development programs in rare genetic diseases which currently includes ALD, Transfusion Dependent Beta-Thalassemia, Sickle Cell Disease and Multiple Myeloma. You will be responsible for review and analysis of all safety data from clinical trials and post-marketing sources for your assigned products, the identification and investigation of safety signals, risk-benefit profile management, aggregate report support, clinical development support (including protocol and Investigator Brochure development), and compliance with all regulatory requirements. This is an individual contributor role with no direct reports.
About the role:
About the role:
- Perform activities required for medical safety support and surveillance for bluebird's products from Phase 1 through postmarketing
- Collaborate with Clinical/Regulatory counterparts to author and/or review all relevant documents to support clinical development and product life-cycle, e.g., clinical trial protocols, IBs, safety management plans, development plans, serious adverse event processing, periodic reports and Regulatory submissions
- Develop and maintenance core product safety information
- Safety data analysis for assigned drug product with responsibility for medical review of individual case safety reports, including coding, seriousness, expectedness and sponsor causality assessment, and analysis of aggregate safety data
- Medical lead and author for signal detection, safety monitoring and risk management plans, documents, and activities
- Contribute to training and mentoring of internal staff and stakeholders
- Periodic review, oversight and communication of safety data, both non-clinical and clinical
- Maintain professional knowledge and accreditation by participation in continuing medical education activities
- Support department initiatives in process improvement and regulatory compliance
- Participation in due diligence activities as required
- Strategic contribution to developing key safety messages for internal and external communication, and review external communication of safety information
- Maintain knowledge of global regulatory authority regulations
- Medical Degree and completion of specialty post-graduate training required
- Medical licensure and Board certification preferred
- 2+ years pharmacovigilance experience within the pharmaceutical industry or as a clinical investigator required
- Experience with safety databases and safety coding dictionaries
- Working knowledge of clinical pharmacology, epidemiology and statistics
- Demonstrated skills in critical thinking, data analysis, problem solving, organizational effectiveness and decision-making
- Fluent in spoken and written English
- Excellent oral and written communication skills, including ability to present to large internal/external audiences
- Capacity and willingness to work across multiple therapeutic areas and products
- Working knowledge of all stages of clinical development, regulatory requirements, epidemiology and biostatistics
- Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view.
- Independently motivated, detail oriented and good problem solving ability.
- Excellent organizational skills, sufficient to multi-task in an extremely fast-paced environment.
- Be ready to embrace the principles of the bluebird bio culture: b colorful, b cooperative, and b yourself