Director/senior Director, DMPK And Clinical Pharmacology

IDEAYA Biosciences (NASDAQ: IDYA) is a public, clinical-stage precision medicine oncology company committed to the discovery and development of targeted therapeutics for patient populations selected using DNA sequencing and other molecular diagnostics. 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 are applying these capabilities across multiple classes of precision medicine, including 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 an industry leading platform and pipeline in precision medicine / synthetic lethality. IDEAYA wholly-owns or controls its three most-advanced clinical programs.  It has established strategic collaborations with GSK, Amgen, Pfizer and Gilead supporting certain clinical and preclinical pipeline programs.   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.

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

What you’ll do: Provide expert guidance on all aspects of clinical pharmacology programs supporting drug discovery and clinical development, including authoring clinical protocols, study reports, data analysis (exposure/efficacy/safety) to supporting development and registration of IDEAYA products.  One of the key roles of this position is to apply state-of-art pharmacometrics methodologies that encompass disease, drug exposures, and modelling to support drug discovery, development and regulatory decisions. Expertise in model-based analyses such as population pharmacokinetic and pharmacokinetic-pharmacodynamic modelling, exposure-response (ER) analyses, quantitative systems pharmacology modelling (QSP), physiological-based pharmacokinetic (PBPK) modelling, optimal study design, are highly desired. 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 support appropriate pharmacometrics analyses and ensure compliance with agreed protocols, quality standards and timelines

Requirements:

• Ph.D. PharmD (minimum 10 years of industry experience) in pharmaceutical Sciences, Pharmacokinetics, Clinical Pharmacology, Chemistry, or related field
• Extensive pharmacometrics analysis experiences with proven track record of independent hands-on experience in study design, data analysis, modeling-simulation. Proficiency in using modeling software packages (i.e., Phoenix WinNonlin, NONMEM, R, SAS, or other similar tools)
• Excellent interpersonal, organizational, and teamwork skills required to communicate effectively with external collaborators and internal project teams.
• Strong knowledge of model-informed drug development, DMPK-Clinical Pharmacology concepts, and regulatory requirements to support clinical development and regulatory submission.
• Experience with managing external resources including CROs and consultants
• Ability to multi-task in a fast-paced dynamic environment while demonstrating a calm and positive attitude and a superior work ethic