Senior Medical Director, Patient Safety & Pharmacovigilance
Company: IDEAYA Biosciences
Location: South San Francisco
Posted on: December 31, 2025
|
|
|
Job Description:
Non-Solicitation Policy and Notice to Agencies and Recruiters:
IDEAYA's Non-Solicitation Policy strictly prohibits agencies and
recruiters from any contact and communication with IDEAYA
employees, managers, and leaders to submit unsolicited candidate
resumes and/or to solicit business partnerships . Submission of
unsolicited candidate resumes by agencies or recruiters with or
without a contract in place with IDEAYA Biosciences Inc. will not
create any implied obligation. Failure to comply with this policy
will result in disqualification from current and future business
opportunities with IDEAYA Biosciences. All recruiting and talent
agency decisions are strictly managed by the internal IDEAYA Human
Resources function. All communication by external agencies and
recruiters must be directed to humanresources@ideayabio.com. We ask
that you only email your interest once. Job Summary About IDEAYA
Biosciences: IDEAYA is a precision medicine oncology company
committed to the discovery, development, and commercialization of
transformative therapies for cancer. Our approach integrates
expertise in small-molecule drug discovery, structural biology and
bioinformatics with robust internal capabilities in identifying and
validating translational biomarkers to develop tailored,
potentially first-in-class targeted therapies aligned to the
genetic drivers of disease. We have built a deep pipeline of
product candidates focused on synthetic lethality and antibody-drug
conjugates, or ADCs, for molecularly defined solid tumor
indications. Our mission is to bring forth the next wave of
precision oncology therapies that are more selective, more
effective, and deeply personalized with the goal of altering the
course of disease and improving clinical outcomes for patients with
cancer. 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 team work to move
science forward. For more information, please see
www.ideayabio.com. Location: South San Francisco or San Diego, CA.
Position Summary: We are seeking an experienced Senior Medical
Director of Patient Safety & Pharmacovigilance to join IDEAYA. 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 or San Diego offices and required
to be onsite four days per week per our company policy. Job
Description 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. 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. The expected salary range for the roleof Senior Medical
Director, Patient Safety & Pharmacovigilance is $287,000 –
$355,000. 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 in the office at the Company’s
facilities for training & meetings, with 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. 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.
Keywords: IDEAYA Biosciences, Fremont , Senior Medical Director, Patient Safety & Pharmacovigilance, Science, Research & Development , South San Francisco, California