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Director, Safety Science Leader

hace 2 meses

Barcelona, Barcelona, España Alexion A tiempo completo

Job Title: Director, Safety Science Leader

Location: Global

Job Summary:

Alexion is seeking a highly experienced Director, Safety Science Leader 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:

  1. Lead Risk Management Evaluation and Resolution: Oversee the evaluation and resolution of risks associated with assigned products and projects, ensuring compliance with global regulatory requirements.
  2. Strategic Leadership: Provide strategic leadership in a cross-functional matrix, driving business growth and ensuring alignment with company objectives.
  3. Team Management: Organize, train and/or support junior safety scientists and fellows across multiple product portfolios and/or indications, fostering a culture of excellence and collaboration.
  4. Regulatory Compliance: Co-lead activities related to new drug applications and other regulatory filings, ensuring timely and accurate submissions.
  5. Regulatory Inspections: Represent Alexion at regulatory inspections, ensuring compliance with global regulatory requirements.
  6. Process Improvement: Lead analysis to identify and address changes in global regulations, including updates to SOP and process documentation.
  7. Process Gaps: Identify and address process gaps, ensuring seamless operations and compliance.
  8. Vendor Management: Manage vendor relationships, including training and budgeting.
  9. Project Management: Manage overall project distribution across therapeutic areas, ensuring timely and effective delivery.
  10. Team Representation: Represent Alexion in global program teams and associated cross-functional teams and/or projects as needed.
  11. Guidance and Training: Proactively provide guidance and educational training to Alexion therapeutic teams.
  12. Safety Data Review: Participate in ongoing safety data review and analysis for products in designated therapeutic areas.
  13. Signal Review: Responsible for Signal Review Meeting and Signal Management Team activities in collaboration with Alexion Medical Directors.
  14. Safety Document Management: Project manage and author safety documents, including PSUR, PBER, PADER, RMP, REMS, CSRs, and ad hoc requests in collaboration with safety physicians.
  15. Regulatory Responses: Author safety sections in collaboration with team members on regulatory responses, IBs/CCDS, protocol, ICF review, Data Monitoring Committees reports and requests, ensuring alignment with core safety position.
  16. Risk Management Portfolio: Manage a portfolio of products/projects related to risk management; assist Safety Physicians in the development of risk management strategy and activities for assigned products.

Requirements:

  1. Advanced Degree: 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.
  2. Regulatory Knowledge: Knowledge and understanding of US and EU safety regulations pre- and post-marketing.
  3. Risk Management Experience: Experience with Risk Management and Minimization programs.
  4. Regulatory Document Preparation: Experience preparing post-marketing safety regulatory documents including PSURs, PBRERs and Risk Management Plans.
  5. Clinical Development Experience: Experience with clinical development including risk/benefit analysis and safety assessment.
  6. Strong Skills: Strong clinical, analytical, problem-solving, scientific writing and communication skills.

Work Environment:

The duties of this role are generally conducted in an office environment.