Job Summary

ABOUT IDEAYA:

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.

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:

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.

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.

Salary Range: $287,292 – $354,891

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, 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.

IDEAYA Biosciences jobs

Senior Medical Director, Patient Safety & Pharmacovigilance

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