Senior Medical Safety Director, Medical Safety Director, or Associate Medical Safety Director
We are a gene therapy company changing lives with every genetic advancement.
Asklepios BioPharmaceutical, Inc. (AskBio) is a leading, clinical-stage gene therapy company founded in 2001 based on the work of adeno-associated virus (AAV) gene therapy visionary and pioneer, Jude Samulski, PhD. Since that time, our commitment to developing life-saving medicines that cure genetic diseases has never wavered.
As the only end-to-end gene therapy company in the industry, we’ve built a foundation of therapeutic programs, AAV manufacturing and a rich portfolio of patented technology. Our therapeutic focus includes neuromuscular, central nervous system, cardiovascular and metabolic diseases with clinical trials underway for Pompe disease, Parkinson’s disease and congestive heart failure. Our gene therapy platform includes Pro10™, an industry-leading proprietary cell line manufacturing process, and an extensive AAV capsid and promoter library.
We became a wholly owned, independently operated subsidiary of Bayer AG in late 2020 as a cornerstone of its newly formed Cell & Gene Therapy Platform. Our global headquarters are in Research Triangle Park, North Carolina, a thriving biotechnology hub, and we maintain additional research and development operations in Scotland and France and gene therapy manufacturing in Spain.
We have an opportunity for a Sr. Medical Safety Director- Medical Safety Director – Associate Medical Safety Director to join the AskBio team in our Research Triangle Park, Durham NC location and be part of our continued success!
About the Role:
Responsible for the leadership and oversight of investigational product safety in preclinical and clinical development. The Senior Director, Director, or Associate Director will interact with and influence other development and medical functions or leaders (Program Heads, Clinical Operations, Regulatory affairs, Analytical Science, Clinical Sciences, etc.) to ensure the successful development, design and implementation of comprehensive safety assessment protocols and plans. The incumbent will be a key player in the preparation and presentation of materials to the safety review committees and similar forums. She or he will contribute to IND and BLA/NDA preparations and submissions. The role has high impact on development programs and has opportunities for career growth into a senior leadership position.
Responsibilities and Accountabilities:
- In conjunction with VP Clinical Sciences and Chief Development Officer/Chief Medical Officer, will lead and direct the interpretation of safety data from internal and external clinical studies and make recommendation to senior management for “go/no go” decisions or modification of development plans and/or study designs
- Responsible for reviewing, analyzing, and interpreting information from ongoing clinical and non-clinical studies and making recommendations based on new safety information for both investigational and marketed products to ensure patients’ safety
- Partner with Clinical Quality to create or update SOPs for clinical safety, monitoring, assessment and reporting
- Partner with Clinical Sciences, Clinical Operations, and other development and medical functions to author, review, and sign off safety sections of trial protocols, safety analysis plans, safety narratives, and safety sections of regulatory dossiers
- Serve as the SME in medical safety/pharmacovigilance (PV) for safety monitoring and risk management assessment and analysis
- Oversees the medical safety evaluation of projects by consultant medical safety physicians
- Represent medical safety in interactions with regulatory authorities and medical and patient communities
- Anticipate regulatory implications of emerging safety issues and develop strategies for mitigation
- Maintain professional knowledge and accreditation by active participation in continuing medical education activities and ICH-GCP training
- Minimum of 5 years’ experience in medical safety/pharmacovigilance, clinical research or clinical development, including a minimum of 3 years in a medical safety/pharmacovigilance organization.
- Experience in preparation and review of safety analysis plans, safety sections of clinical study protocols and reports, and IND/BLA/NDA dossiers is required
- Experience in preparing responses to regulatory agencies on safety-related topics and aggregate analysis of safety data is desired
- Experience in preparation and review of AE and SAE reports is required
- Excellent communication and leadership skills
- Demonstrate integrity and patient-centric mentality
- Accomplishments in drug development or medical safety
- Ability to crystalize objectives and prioritize deliverables
- Experience in gene therapy or regenerative medicine R&D a plus
- Proven ability and track record to work in international environment and with cross-functional teams
MD degree or international equivalent is preferred; Direct clinical practice and patient care experience following graduation of medical school a plus; strong candidates with DVM, PhD, or PharmD degree will be considered
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