Director, DMPK and Clinical Pharmacology

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 HR@ideayabio.com 
Position Summary:We are seeking a talented and highly motivated Director of DMPK-Clinical Pharmacology with significant clinical pharmacology experience to join our multidisciplinary team based in South San Francisco. The role requires the candidate to work collaboratively with the related cross-functional teams to drive project progression. The candidate will represent line function on project teams providing strategic leadership and “hands-on” execution of development strategy to fulfill registration requirements across IDEAYA early and late-stage programs
This position is based in our South San Francisco headquarters and required to be onsite four days per week per our company policy.

What you'll do:

• Provide expert guidance on all aspects of DMPK-clinical pharmacology programs supporting clinical development, including formulating and delivering clinical pharmacology development plan from FIP to registration and new product label to characterize intrinsic/extrinsic drivers of patient response, authoring clinical protocols, study reports, data analysis (exposure/efficacy/safety) to supporting development and registration of IDEAYA products. 
• Apply principles of drug action and state-of-art clinical pharmacology approaches to characterize drug disposition and assess the pharmacodynamics of drug effect to inform dosage selection, drug combinations, and go/no-go decisions.
• Work with early and late clinical development, biometrics, drug safety, regulatory, CROs and other relevant line functions to support future and ongoing oncology studies to ensure timely conversion of data to knowledge, publication strategy, aligned with programmatic deliverables and milestones.
• Contribute and drive quantitative strategy, study design, protocol preparation, amendments, data analysis, regulatory document and health authority (HA) strategy and timely HA responses
• Provide high-quality scientific knowledge/insight and drive the customized clinical pharmacology and DMPK plans
• Write, review and edit relevant sections of regulatory documents ((IND’s, NDA’s, IB’s, etc.) and respond to regulatory inquires related to line function
• Ensuring adherence to agreed timelines and budgets to insure prompt and accurate execution of deliverables from clinical pharmacology studies and programs
• Lead writing of scientific publications on relevant topics - abstracts, posters, oral presentations and manuscripts
• Engage and manage CRO’s to ensure compliance