Senior Medical Director, Patient Safety & Pharmacovigilance

IDEAYA Biosciences; San Diego (CA); On-site; USD 287,000 - 355,000; Full time

Job summary

An established industry player is seeking a Senior Medical Director to lead patient safety initiatives for oncology drug development. This pivotal role involves strategic oversight, risk mitigation, and collaboration with regulatory authorities. The ideal candidate will bring extensive experience in pharmacovigilance and a passion for improving patient outcomes. Join a dynamic team dedicated to advancing precision medicine and making a significant impact in oncology. This is an exciting opportunity to be at the forefront of innovative therapies that address high unmet clinical needs.

Benefits

401k

Medical/Dental/Vision Coverage

Wellness Programs

Company Equity

Annual Performance Bonus

Qualifications

• 8+ years of safety experience in drug development.
• Strong expertise in global pharmacovigilance regulations.

Responsibilities

• Lead patient safety and risk assessment strategies for oncology drug development.
• Collaborate with regulatory authorities and manage safety practices.

Skills

Pharmacovigilance

Risk Mitigation

Patient Safety

Regulatory Compliance

Team Leadership

Education

M.D. or D.O. degree

Job description

Senior Medical Director, Patient Safety & Pharmacovigilance

Senior Medical Director, Patient Safety & Pharmacovigilance

3 weeks ago Be among the first 25 applicants

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This range is provided by IDEAYA Biosciences. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$287,292.00/yr - $354,891.00/yr

IDEAYA Biosciences (NASDAQ: IDYA) is a public, clinical-stage precision medicine oncology company committed to the discovery, development, and commercialization of targeted therapeutics for patient populations with high unmet clinical needs. Our approach integrates extensive capabilities in identifying and validating translational biomarkers with small molecule drug discovery to select patient populations most likely to benefit from the therapies we are developing. We have developed an industry leading platform and pipeline in precision medicine by applying these capabilities across multiple approaches such as direct targeting of oncogenic pathways and synthetic lethality, which represents an emerging class of precision medicine targets. We believe this diversified approach will enable us to deliver the right medicine to the right patient to drive a more robust clinical response. IDEAYA has established strategic collaborations with GSK, Merck, Pfizer, and Gilead but wholly-owns or controls its four most-advanced clinical programs and we are committed to building a best-in-industry organization to deliver our precision medicines to the people who need them.

When you're at IDEAYA, you will be in the midst of brilliant minds working on precision medicine therapies to help cancer patients. We are passionate and committed about being on the forefront of oncology medicine, which means we all have a high internal drive that is at the very core of every person at IDEAYA. We are inquisitive, ask deep questions, and are data-driven innovators who like to collaborate and use teamwork to move science forward. For more information, please see www.ideayabio.com.

Notice to Agencies and Recruiters:

All open positions and candidate activity are strictly managed through Human Resources. Please note that our policy is that recruiters do not contact employees/hiring managers directly to solicit business and/or present candidates. Submission of unsolicited resumes prior to an agreement set in place between the Human Resources Department and the recruiting agency will not create any implied obligation. Please note that failure to comply with this request will be a factor in developing a professional relationship with IDEAYA Bio. Inquiries regarding developing a recruiting relationship with us, may be directed to [e-mail]

Position Summary:
The Senior Medical Director will serve as the primary medical expert and leader for Ideaya Biosciences’ oncology drug development portfolio, focusing on patient safety, safety signal management, risk mitigation, and benefit-risk assessment strategies (BRAT/BRAD). Reporting directly to the Vice President of Drug Safety, this role is pivotal to the safety leadership team and involves strategic oversight, cross-functional collaboration, and interaction with external regulatory authorities.

This position is based in our South San Francisco headquarter office or San Diego office and required to be onsite four days per week per our company policy.

What you'll do:

• Serve as the primary medical expert and leader for Ideaya Biosciences’ oncology drug development portfolio, driving patient safety, safety signal management, risk mitigation, and benefit-risk assessment strategies (BRAT/BRAD).
• Report directly to the Vice President of Drug Safety and play a pivotal role on the safety leadership team.
• Foster collaboration across all levels of the organization and with external Regulatory Authorities. Attend Study Management Team meetings.
• Manage and mentor safety physicians and scientists, providing guidance and oversight to ensure operational excellence in safety practices.
• Develop, implement, and oversee signal detection strategies, leading the Safety Review Committee's executive meetings.
• Prepare, review, and oversee periodic safety reports, including IND Annual Reports, DSURs, PBRERs/PSURs, PADERs, and EU renewals.
• Author and review clinical trial protocols, Investigator’s Brochure (IB), Company Core Data Sheets (CCDS/CCSI), TPP, informed consent forms (ICF), and study-specific documents like BRAT and BRAD, ensuring alignment with benefit-risk profiles.
• Lead the creation of developmental risk management plans with input from cross-functional teams and provide strategic medical insights into regulatory safety assessments and inquiries.
• Contribute to and oversee the preparation of regulatory filings, including INDs, NDAs, and Marketing Authorization Applications.
• Participate in and provide input for Drug Monitoring Committees (iDMC) and contribute to scientific publications for meetings and journals.
• Support medical safety evaluations for new business opportunities and due diligence assessments. Recruit, hire, mentor, and manage direct reports, conducting performance evaluations and fostering professional growth.
• Collaborate with safety operations to ensure SOPs are developed, implemented, and compliant with regulatory and partner inspection requirements.
• Perform medical reviews of Serious Adverse Events (SAEs) and assist with narrative writing.
  
  
  
  
  

Requirements:

• M.D. or D.O. degree with completed residency training (mandatory).
• Minimum of 8 years of safety experience
• Proven ability to establish, evaluate, and optimize safety-related business processes, tools, and systems.
• Strong expertise in global pharmacovigilance regulations and requirements (EMA, FDA, PMDA, Asia-PAC, ICH).
• Exceptional interpersonal, communication, analytical, and organizational skills.
• Demonstrated success in building and leading high-performing teams in a dynamic, fast-paced environment.
• Robust people and project management skills, with experience coaching and mentoring teams.
• Track record of managing safety leadership roles with cross-functional collaboration.
• Must be authorized to work in the United States on a full-time basis.
  
  
  
  
  

At IDEAYA Biosciences, we care about our employees and strive to provide a market-competitive total rewards package, including base pay, an annual performance bonus, company equity, and generous health and well-being benefits. The expected salary range for this role that is based in our South San Francisco or San Diego, California office is $287,292 - $354,891.

The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the office location where this open position is located, the final candidates’ experience within their profession, experience in the disease areas we are striving to make an impact in as a company, length of time within the industry, educational background, and performance during the interview process.

The Company complies with all laws respecting equal employment opportunities and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state, and local law. This position requires you to work onsite at the Company’s facilities, with partial work-from-home flexibility, and the Company requires that all employees working in its facilities be fully vaccinated (except as required by applicable law). Therefore, this position requires you to be fully vaccinated from COVID-19, subject to reasonable accommodations for medical or religious reasons, and/or as otherwise required by applicable law. The Company considers you fully vaccinated once 14 days have passed since you received either the second dose in a two-dose COVID-19 vaccine series or a single-dose COVID-19 vaccine. The vaccine must have been FDA approved, have emergency use authorization from the FDA, or, for persons fully vaccinated outside of the U.S., be listed for emergency use by the World Health Organization.

Total Rewards:
Along with our inspiring mission, and highly collaborative and inclusive environment, IDEAYA offers a competitive total rewards package that reflects our pay-for-performance philosophy where employees are eligible to be considered for merit-based salary increases, company discretionary short-term incentive plan participation, and company discretionary stock option awards (based on board approval). Our comprehensive benefits package includes, but is not limited to, medical/dental/vision coverage (100% company paid for employees and 90% company paid for dependents), 401k, ESPP, and wellness programs.

IDEAYA is an equal opportunity employer. In accordance with applicable law, IDEAYA does not discriminate in hiring or otherwise in employment based on race, color, religion, sex, national origin, age, marital or veteran status, disability, sexual orientation, or any other legally protected status. EOE/AA/Vets.

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Seniority level

• Seniority level

  Not Applicable

Employment type

• Employment type

  Full-time

Job function

• Job function

  Health Care Provider

• Industries

  Hospitality, Food and Beverage Services, and Retail

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