Global Safety Lead (Director), Medical Safety and Risk Management (Chevy Chase)

CK Technologies, LLC in Chevy Chase, MD

  • Industry: Healthcare - Allied Health - Medical Technologist (MLS)
  • Type: Full Time
  • $123,910.00 - 144,830.00
position filled

Global Safety Lead (Director), Medical Safety and Risk Management Location Agios Pharmaceuticals HQ Job Code 1027 # of openings 1

Global Safety Lead (Director), Medical Safety and Risk Management

Agios (agios.com) is a biopharmaceutical company committed to applying our scientific leadership in cellular metabolism to transform the lives of patients with cancer and rare genetic diseases. We are growing rapidly with an active research and discovery pipeline across both therapeutic areas. Agios has two approved oncology precision medicines and multiple first-in-class investigational therapies in clinical and/or preclinical development.

This role is an exciting opportunity within the Medical Safety and Risk Management function at Agios to lead safety and risk management activities on early- and late-stage assets in the hematology and solid tumor oncology therapeutic areas. The Medical Director is a drug safety expert and monitors the safety profiles for assigned products, maintains current knowledge of full product portfolio, and mentors junior physicians and scientists.

Key Responsibilities

  • Partner with the Therapeutic Area Head to develop the strategic roadmap for managing the safety of assigned products and development compounds.
  • Proactive assessment/evaluation of safety data from all sources (including pre-clinical studies, clinical studies, literature, registries).
  • Provide medical expert safety review input into all critical documents for clinical development of products (e.g., protocols and amendments, ICFs, IBs, IMPDs, clinical study reports, INDs, CTAs).
  • Provide Drug Safety input for product recall issues or Health Hazard Evaluations and Dear Healthcare Professional letters.
  • Accountable for the safety components of aggregate reports, regulatory responses and filing documents.
  • Contribute to the development of key safety concepts for internal communications and review of all safety communication to the public.
  • Responsible for key content of Risk Management documents (RMPs, REMS).
  • Conduct/support signal detection and evaluation according to SOPs and guidelines in collaboration with safety scientists.
  • Contribute to scientific publications (abstracts, posters, papers) for scientific meetings and approve submissions from a safety perspective.
  • MD/DO with completion of a residency
  • Strong written and verbal communication skills; demonstrated persuasion, influencing, and negotiation skills
  • Ability to interact effectively in cross-functional teams

Preferred Qualifications

  • Previous experience in drug safety pre-approval (ranging from early to late-stage) and in the post-marketing setting
  • Demonstrated knowledge of pharmacovigilance and risk management
  • Previous NDA/MAA filing experience
  • Board-certification in specialty area
  • Previous post-training medical practice experience


Associated topics: constable, emr, environment, hazard, health, hospital, safety, sewer system, scba, usda

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