Senior Director, Clinical Pharmacology and Quantitative Pharmacology

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 highly motivated and energetic individual with a relevant scientific background to be part of the Nonclinical Development and Clinical Pharmacology (NDCP) Organization.

As a key member of the Clinical Pharmacology group you will :

Responsible for clinical pipeline delivery through major milestones including IND / CTA EOP2 and marketing applications NDA / sNDA.

Lead the design and execution of an integrated clinical pharmacology and modeling and simulation strategy to guide the clinical development plan.

Apply state-of-the-art quantitative pharmacology analyses including PBPK translational PK / PD population PK exposure-response analyses and system pharmacology to guide dose / schedule selection and recommended phase 2 dose and schedule (RP2Ds) selection.

Author and provide technical input for regulatory documents and submissions related to all aspects of clinical pharmacology (including protocol IB briefing package etc) and responses to regulatory questions.

Engage and work with consultants and / or CROs on clinical pharmacology activities to complement in-house knowledge / expertise and capacities.

Represent the clinical pharmacology function in project teams and build strong working relationships with cross-functional teams to impact critical decisions.

Abilty to manage internship and fellowship programs.

Required Skills Experience and Education :

A Ph.D. or Pharm.D. with 8-10 years of relevant industry experience in Clinical and Quantitative pharmacology.

Expertise in clinical pharmacology hands-on modeling and simulation skills using NONMEM R and / or other modeling and simulation software. Experience with population PK exposure-response and advanced mechanistic PK / PD models.

Track record of applying modeling and simulation methodologies to inform and accelerate drug development.

Well-informed in current and emerging scientific standards of regulatory requirements and expectations.

Excellent verbal and written communication skills and ability to clearly convey complex concepts and findings to both non-specialist and specialist audiences.

Strong interpersonal skills and ability to influence development project and management teams.

A critical thinker and passionate team player with high energy who thrives in a dynamic and fast-paced environment.

Preferred Skills :

Hand-on experience with PBPK models using SimCYP and PK-sim.

Prior experience with small molecules in oncology drug development.

Prior experience with authoring regulatory documents such as IND / CTA EOP2 and marketing applications NDA / sNDA.

#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 our CCPA additional information please contact .

Base Pay Salary Range

$244000 $305000 USD

Required Experience :

Exec

Key Skills

CSS,Cloud Computing,Health Education,Actuary,Building Electrician

Employment Type : Full Time

Experience : years

Vacancy : 1