Director, Safety Science Leader
hace 2 semanas
**Job Summary**
At Alexion, we are seeking a highly experienced and skilled Director, Safety Science to join our team. As a key member of our Global Patient Safety organization, you will play a leadership role in organizing and mentoring safety scientists to actively evaluate, manage, and strategize risk in collaboration with cross-functional team members within the global regulatory framework.
**Key Responsibilities**
- Lead risk management evaluation and resolution for assigned products and projects.
- Accountability for the following:
- Proven skill set for strategic leadership in a cross-functional matrix.
- Organize, train, and/or support junior safety scientists and fellows across multiple product portfolios and/or indications.
- Co-lead activities related to new drug applications and other regulatory filings.
- Represent global patient safety at regulatory inspections.
- Lead analysis to identify and address changes in global regulations, including updates to SOP and process documentation.
- Leading activities to identify and address process gaps.
- Responsible for vendor management and training, including budgets.
- Responsible for overall project distribution across therapeutic area.
- As needed, represent GPS in global program teams and associated cross-functional teams and/or projects.
- Proactively provide guidance and educational training to GPS therapeutic teams.
- Participate in ongoing safety data review and analysis for products in designated therapeutic areas.
- Responsible for Signal Review Meeting and Signal Management Team activities in collaboration with GPS Medical Directors.
- Responsible for project managing and authoring of safety documents, including PSUR, PBER, PADER, RMP, REMS, CSRs, and ad hoc requests in collaboration with safety physicians.
- Responsible for authoring safety section in collaboration with team members on regulatory responses, IBs/CCDS, protocol, ICF review, Data Monitoring Committees reports and requests, and other documents, and provide the necessary quality control to ensure alignment with core safety position.
- Manage portfolio of products/projects related to risk management; assists Safety Physicians in the development of risk management strategy and activities for assigned products.
**Requirements**
- Advanced degree in a biologic/medical/clinical/nursing field: Pharmacist/PharmD, Nurse Practitioner or PhD with at least 7 years experience in drug safety and risk management within the pharmaceutical, biotech, or CRO industry.
- Knowledge and understanding of US and EU safety regulations pre- and post-marketing.
- Experience with Risk Management and Minimization programs.
- Experience preparing post-marketing safety regulatory documents, including PSURs, PBRERs, and Risk Management Plans.
- Experience with clinical development, including risk/benefit analysis and safety assessment.
- Strong clinical, analytical, problem-solving, and scientific writing and communication skills.
**Work Environment**
The duties of this role are generally conducted in an office environment.
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