Director, Safety Science
Location: San Diego
Posted on: June 23, 2025
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Job Description:
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 IDEAYA Biosciences, Inc’s
Human Resources department. 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 by agencies, with or without an agreement in
place with IDEAYA Biosciences, Inc., will not create any implied
obligation. Please note that failure to comply with this policy
will be a factor in developing or continuing a professional
relationship with IDEAYA Biosciences, Inc. Position Summary:
Reporting to the Vice President of Drug Safety, this role leads
safety monitoring for investigational and marketed products,
ensuring compliance with corporate strategies and regulatory
standards. Responsibilities include managing safety deliverables
(e.g., governance, signal detection, reporting), supervising safety
scientists, and conducting safety analyses.The position oversees
Risk Management Plans (RMPs), Risk Evaluation and Mitigation
Strategies (REMS), and the preparation of regulatory safety
documents (e.g., PBRERs, DSURs, NDAs). It involves cross-functional
collaboration on signal detection, risk management, and
benefit-risk assessments, while maintaining expertise in drug
safety and regulatory trends. Additional duties include vendor
oversight, process improvements, and participation in audits and
inspections. This position is based in our South San Francisco
headquarter offices or San Diego office and required to be onsite
four days per week per our company policy. What you'll do: Report
directly to the Vice President of Drug Safety and indirectly to the
Senior Medical Director of Drug Safety. Lead safety monitoring for
investigational and marketed products, ensuring alignment with
corporate development strategies. Oversee core safety deliverables,
including safety governance, signal detection/management,
periodic/aggregate reporting, and case processing. Supervise and
mentor all safety scientists, fostering a collaborative and
high-performing team. Conduct safety analyses using case series,
data summaries, adverse event trends, and clinical/post-marketing
data. Review medical and scientific literature for signal detection
and aggregate reporting. Develop and maintain product-specific Risk
Management Plans (RMPs) and Risk Evaluation and Mitigation
Strategies (REMS). Perform safety data monitoring, interpretation,
and analysis. Lead the preparation of safety deliverables,
including integrated safety reports and regulatory documents (e.g.,
PBRER/PSUR, DSUR, PADERs). Provide safety input to clinical
documents such as Investigator’s Brochures, study protocols, and
clinical study reports. Ensure consistency in safety and risk
management content across regulatory submissions. Partner with
safety physicians and cross-functional teams on signal detection
and risk management activities. Participate in safety governance
meetings and contribute to benefit-risk assessments. Author and
review safety sections for regulatory packages, including NDAs and
responses to health authority queries. Support pharmacovigilance
vendor oversight, process improvement initiatives, and
inspections/audits. Maintain up-to-date expertise in disease areas,
drug safety, regulatory trends, and business practices.
Requirements: PharmD, RN, or MD required; advanced degrees (e.g.,
Master’s) preferred. At least 6 years of experience in patient
safety and pharmacovigilance, including team management. More than
3 years of experience authoring and reviewing periodic/ad hoc
safety reports and clinical documents (e.g., PSURs, DSURs, Clinical
Overviews). Expertise in safety analyses, signal detection, risk
management, and health authority responses. Experience with NDA/MAA
filings. Strong ability to interpret and integrate safety data.
Effective communication skills (written and verbal) for internal
and external audiences. Proven leadership in mentoring and managing
scientific teams. Must be authorized to work in the United States
on a full-time basis. $235,144 - $290,472 a year 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 $235,144 - $290,472. 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. California Job Applicant Privacy
Notice
Keywords: , Oceanside , Director, Safety Science, Science, Research & Development , San Diego, California