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Position:
Director, DMPK and Clinical Pharmacology

Employer:
Ideaya Biosciences Inc

Description:

About IDEAYA Biosciences:

IDEAYA Biosciences (NASDAQ: IDYA) is a public, clinical-stage oncology-focused precision medicine 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 recently announced a landmark strategic partnership with GSK in Synthetic Lethality for certain pipeline programs. The GSK partnership is transformative and enables IDEAYA and GSK to collectively build an industry leading platform and pipeline in Synthetic Lethality. For more information, please see www.ideayabio.com.

The Opportunity:

We are seeking a talented and highly motivated Director of DMPK and Clinical Pharmacology with significant pharmaceutical industry experience to join our multidisciplinary team based in South San Francisco. The successful candidate will be responsible for the analysis and interpretation of all PK and PD data and for the design of non-clinical and human PK studies.

The role requires the candidate to work collaboratively with the related cross-functional teams to identify first in human dose, the maximum tolerated dose, recommended Phase 2 dose, and dosing schedule for each program. The candidate will represent their function on core pre-clinical and clinical development project teams to guide clinical pharmacology and PK/PD modeling strategy, and to work within relevant sub-teams to ensure tactical alignment and execution.

Responsibilities:

  • Provide expert guidance on all aspects of clinical and non-clinical pharmacokinetics and clinical pharmacology programs supporting early clinical development
  • Participate in study design, vendor selection, study execution, interpretation and report writing for molecules that pertain to PK and PK/PD assessment in research/development
  • Provide high-quality scientific knowledge/insight and drive the customized clinical pharmacology plan for each molecule
  • Design and oversee non-clinical ADME studies; make pertinent recommendations to project teams to solve ADME issues
  • Design human PK, ADME and DDI studies and write the protocol sections related to these study components
  • Uses model-informed drug development strategies that are aligned with project needs
  • Assist with or oversee bioanalysis assay development and vendor management
  • Write, review and edit relevant sections of global regulatory submissions - IND, IMPD, CTA, CSR, etc.
  • 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
  • Work collaboratively with research and development sciences on PK and PK/PD aspects of non-clinical studies
  • Participate in the due diligence process delivering sound scientific analysis augmented by industrial experiences and attention to details
  • Maintain up-to-date knowledge of evolving PK/PD regulatory requirements and climate in US and Europe and possibly Asia
  • Engage and manage CRO’s and consultants as required


Qualifications/Experience:
  • Ph.D. in Pharmaceutical Sciences, Quantitative Pharmacokinetics/Pharmacodynamics, Pharmacology, or related discipline with a focus on pharmacokinetics and PK/PD modeling and simulation
  • 10+ years pharmaceutical industrial experience in PK study design, PK analysis, population PK analysis, PK/PD and PBPK modeling, human dose prediction and report writing
  • Hands-on experience using PK/PD software including WinNonLin and GastroPlus
  • Broad understanding of drug development especially oncology
  • Experience with, and demonstrated ability to, manage CRO’s
  • Working knowledge of regulatory guidance for PK analysis and clinical pharmacology
  • Ability to collaborate and effectively lead cross-functionally and in a team setting
  • Excellent interpersonal and written communication skills in English (other languages a plus)
  • Dynamic and innovative scientist with a well-developed sense of teamwork. He or she will have the interpersonal skills required to communicate effectively with external collaborators and internal project teams.
  • Ability to multi-task in a fast-paced dynamic environment while demonstrating a calm and positive attitude and a superior work ethic
  • Ability to mentor junior level scientists, including direct reports or supporting team members

Benefits:

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.

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.

Apply here



Location: South San Francisco, CA

Contact:

Post Date: 7/20/2020 9:53:35 AM
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