- Provide strategic insight and technical leadership within the Clinical Pharmacology and Pharmacometrics function.
- 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 modeling, including population PK and exposure-response analyses, to guide dose/schedule optimization and recommended phase 2 dose/schedule (RP2Ds) selection.
- Perform model-based simulations to optimize dosing to inform trial designs and clinical outcomes. Ensure quality and integrity of modeling and simulation results.
- Author and provide technical input for regulatory documents and submissions related to all aspects of clinical pharmacology and pharmacometrics (including protocol, IB, briefing package, etc). Participate in regulatory interactions and responses to regulatory questions.
- Engage and work with consultants and/or CROs on clinical pharmacology and pharmacometrics activities to complement in-house knowledge/expertise and capacities.
- Represent the Clinical Pharmacology and Pharmacometrics function in project teams and build strong working relationships with cross-functional teams to impact critical decisions.
- A Ph.
- Hands-on experience with NONMEM. Track record of applying model-informed drug development (MIDD) to inform and accelerate drug development.
- Demonstrated experience and track record in designing and executing clinical pharmacology and pharmacometrics components of clinical studies.
- 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.
- Prior experience with small molecule oncology drug development.
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Director, Clinical Pharmacology and Pharmacometrics - Redwood City, United States - Revolution Medicines, Inc.
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 company's 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 professionals 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.
Responsibilities:
As a key member in Clinical Pharmacology and Pharmacometrics, you will:
Required Skills, Experience and Education:
D. with 10+ years of clinical pharmacology and pharmacometrics or relevant industry experience.
Preferred Skills, Experience and Education:
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 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 Notice and Privacy Policy.
For additional information, please contact
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