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Senior Medical Director, Patient Safety & Pharmacovigilance

8+ years
$287K-$355K / yr.
10 March 3, 2025
Job Description
Job Type: Full Time Education: MD/DO Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Senior Medical Director, Patient Safety & Pharmacovigilance
IDEAYA Biosciences, Inc.
South San Francisco, CA

Salary: $287K - $355K / yr
Employment Type: Full-time

Company Overview:

IDEAYA Biosciences (NASDAQ: IDYA) is a clinical-stage precision medicine oncology company focused on discovering, developing, and commercializing targeted therapeutics for patients with high unmet medical needs. IDEAYA integrates biomarker-based patient selection with small molecule drug discovery to enhance treatment effectiveness. The company has strategic collaborations with GSK, Merck, Pfizer, and Gilead while wholly owning its four most-advanced clinical programs.

Position Summary:

The Senior Medical Director will lead patient safety and pharmacovigilance efforts for IDEAYA’s oncology drug development portfolio. This role focuses on safety signal management, risk mitigation, and benefit-risk assessments while providing strategic oversight and regulatory interactions. The Senior Medical Director will report directly to the Vice President of Drug Safety and will be an integral member of the safety leadership team. The position requires onsite presence four days per week at the South San Francisco or San Diego office.

Key Responsibilities:

  • Lead patient safety, risk mitigation, and benefit-risk assessment strategies (BRAT/BRAD).
  • Provide medical expertise in oncology drug development.
  • Collaborate with internal teams and regulatory authorities.
  • Manage and mentor safety physicians and scientists.
  • Develop and oversee signal detection strategies and chair Safety Review Committee meetings.
  • Author and review key regulatory documents, including:
    • IND Annual Reports, DSURs, PBRERs/PSURs, PADERs, EU renewals.
    • Clinical trial protocols, Investigator's Brochure (IB), Core Data Sheets, and Informed Consent Forms (ICF).
  • Develop risk management plans and provide strategic input for regulatory safety assessments.
  • Support preparation of regulatory filings (INDs, NDAs, Marketing Authorization Applications).
  • Participate in Drug Monitoring Committees (iDMC) and contribute to scientific publications.
  • Conduct medical reviews of Serious Adverse Events (SAEs) and oversee narrative writing.

Requirements:

  • M.D. or D.O. with completed residency training (mandatory).
  • Minimum 8 years of experience in safety and pharmacovigilance.
  • Expertise in global pharmacovigilance regulations (FDA, EMA, PMDA, ICH).
  • Strong leadership and project management skills in a fast-paced environment.
  • Experience mentoring teams and overseeing complex clinical safety operations.
  • Authorized to work in the U.S. on a full-time basis.

Compensation & Benefits:

  • Base Salary: $287,292 - $354,891 per year.
  • Annual performance bonus, company equity, and stock options.
  • Medical, dental, and vision coverage (100% employer-paid for employees, 90% for dependents).
  • 401(k) plan, ESPP, and wellness programs.
  • Hybrid work flexibility (onsite required four days per week).
  • COVID-19 Vaccination Requirement: Employees must be fully vaccinated, subject to legal exemptions.

Equal Opportunity Employer:

IDEAYA Biosciences is committed to diversity and provides equal employment opportunities to all applicants. The company does not discriminate based on race, color, religion, sex, age, national origin, disability, or any legally protected status.