Director, Clinical Pharmacology and Quantitative Pharmacology

Revolution Medicines

Posted on: September 23, 2024

Closing: October 23, 2024

Position Type: Full Time

Job Description

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.

Required Experience, Skills, and Education:

  • A Ph.D. or Pharm.D. with 8+ 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, Experience, and Education:

  • 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.

The expected salary range for this role is $195,000 to $260,000. An individual’s position within the range may be influenced by multiple factors, including skills and experience in role, overall performance, individual impact and contributions, tenure, and market dynamics. Base salary 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

Posted on: September 23, 2024

Closing: October 23, 2024

Position Type: Full Time

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