Director/Senior Director, DMPK and Clinical Pharmacology
1 day ago
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
The salary range for this position at the Director level is between $223,449 and $272,495. The salary range is an estimate and may vary based on the Company’s compensation practices.
The salary range for this position at the Senior Director level is between $273,771 and $337,470. The salary range is an estimate and may vary based on the Company’s compensation practices.
Benefits
Along with our highly collaborative and inclusive environment, IDEAYA offers a comprehensive and competitive benefits package that includes (but is not limited to) medical/dental/vision coverage (100% company paid for employees and 90% company paid for dependents), retirement benefits, ESPP and wellness programs. All full-time employees will also be eligible for an annual bonus and equity refresh.
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.
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