Senior Director, Medical Information and Regulatory Affairs

5 days ago

San Diego, California, United States Crinetics Pharmaceuticals, Inc. Full time
Job Summary

Crinetics Pharmaceuticals, Inc. is seeking a highly experienced Senior Director of Medical Information to lead all activities related to the medical information specialist group. This role is critical in ensuring the development and maintenance of a comprehensive product knowledge database and the accurate and timely dissemination of medical information.

Key Responsibilities
  • Oversee the development and maintenance of the product knowledge database used in responding to medical questions related to Crinetics products.
  • Lead and manage the Medical Information Specialist group, providing strategic direction and support.
  • Recruit, train, and develop team members to maintain a high standard of performance and professional growth.
  • Conduct regular performance evaluations and provide timely constructive feedback.
  • Oversee the development, maintenance, and continuous improvement of the product knowledge database.
  • Ensure the database is comprehensive, up-to-date, and easily accessible for responding to medical inquiries.
  • Collaborate with Clinical Research, Sales & Marketing, Regulatory, and Research teams to obtain necessary product information and updates.
  • Inform internal stakeholders of new issues or developments that may impact product knowledge or medical information dissemination.
  • Provide guidance on the receipt, processing, and dissemination of safety information.
  • Ensure all safety information is handled in compliance with regulatory guidelines and internal protocols.
  • Direct the preparation and submission of reports to regulatory agencies.
  • Ensure all reports are accurate, comprehensive, and submitted within required timelines.
  • Ensure the dissemination of medical information complies with regulatory guidelines and follows established clinical protocols.
  • Stay informed of changes in regulations and adjust processes and practices accordingly.
  • Partner with the Medical Leadership Team to ensure a high-performance team culture and talent development.
Requirements
  • Advanced degree in a scientific or medical discipline (PharmD, MD, PhD preferred).
  • Minimum 10-13 years of experience in medical information or a related field within the biotech or pharmaceutical industry.
  • Direct leadership experience required as well as leading in a Matrix environment.
  • Proven leadership experience, with a track record of managing and developing high-performing teams.
  • Strong knowledge of regulatory guidelines related to medical information and safety reporting.
  • Excellent communication and interpersonal skills, with the ability to effectively interact with a wide range of internal and external stakeholders.
  • Detail-oriented with strong organizational and problem-solving abilities.
  • Proficient in using medical information databases and other relevant software tools.
  • Collaborative, with the ability to build and maintain strong interpersonal relationships, gaining trust and confidence from all levels within the organization.

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