Director, Clinical Pharmacology
Director, Clinical Pharmacology
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Salary Not Disclosed
1 Vacancy
Job Description
Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The companys R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins and RAS Companion Inhibitors for use in combination treatment strategies. As a new member of the Revolution Medicines team you will join other outstanding Revolutionaries in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.
The Opportunity:
We are seeking a passionate and experienced Clinical Pharmacologist with strong early development background to be part of the Nonclinical Development and Clinical Pharmacology (NDCP) Organization.
As a member of the Early Development Clinical Pharmacology group you will:
Provide strategic insight and technical leadership within the Clinical Pharmacology function.
Author technical reports and/or regulatory documents for major milestones of clinical development specifically IND EOP1 & EOP2 Briefing Documents. Participate in regulatory interactions and responses to regulatory questions.
Apply state-of-the-art quantitative modeling including translational PK/PD population PK and exposure-response analyses to guide recommended phase 2 dose/schedule (RP2Ds) selection for pivotal studies.
Work with the Discovery organization to support assets in the IND-enabling stage including collaboration with DMPK and Toxicology groups in assessment of human start dose and assessment of the need for human DDI studies.
Work with the Clinical Development team in designing FIH study.
Design and report Clin Pharm studies such as hADME Food-Effect and DDI studies.
Engage and work with CROs on clinical pharmacology activities.
Represent the Clinical Pharmacology function in project teams and build strong working relationships with cross-functional teams to impact critical decisions.
Required Skills Experience and Education:
A Ph.D. or Pharm.D (with Fellowship) with Pharmaceutical Sciences background with 8 years of relevant industry experience in Clinical Pharmacology.
Prior experience with small molecules oncology drug development.
Familiar with FDAs Project Optimus guidance.
Well-informed in current and emerging standards of regulatory requirements and expectations for clinical pharmacology.
Hands-on experience with WinNonlin and Clin Pharm study designs.
Strong understanding of DMPK CMC and Toxicology and related regulatory guidance is required.
Excellent verbal and written communication skills and ability to clearly convey complex concepts and findings to both non-specialist and specialist audiences.
A critical thinker and passionate team player and quick learner with high energy who thrives in a dynamic and fast-paced environment.
Prior management experience.
Preferred Skills:
Prior experience interacting with FDA on dose optimization.
Hand-on experience with PBPK models. #LI-Hybrid #LI-CT1
The base pay salary range for this full-time position for candidates working onsite at our headquarters in Redwood City CA is listed below. The range displayed on each job posting is intended to be the base pay salary range for an individual working onsite in Redwood City and will be adjusted for the local market a candidate is based in. Our base pay salary ranges are determined by role level and location. Individual base pay salary is determined by multiple factors including job-related skills experience market dynamics and relevant education or training.
Please note that base pay salary range is one part of the overall total rewards program at RevMed which includes competitive cash compensation robust equity awards strong benefits and significant learning and development opportunities.
Revolution Medicines is an equal opportunity employer and prohibits unlawful discrimination based on race color religion gender sexual orientation gender identity/expression national origin/ancestry age disability marital status medical condition and veteran status.
Revolution Medicines takes protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone. We will only collect process and use any personal data that you provide to us in accordance with ourCCPA additional information please contact.
Required Experience:
Director
Employment Type
Full Time
