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Clinical Pharmacology & Pharmacometrics Director

8 years
Not Disclosed
10 Dec. 9, 2025
Job Description
Job Type: Hybrid Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Clinical Pharmacology and Pharmacometrics Director – Global Opportunity
Location: Multiple Global Markets
Organization: Exelixis
Category: Clinical Pharmacology | Drug Development | Leadership


Position Summary

Exelixis is seeking a Clinical Pharmacology and Pharmacometrics Director to lead the design and execution of clinical pharmacology and quantitative modeling strategies that support the advancement of novel drug candidates across all development stages. This senior leader will partner closely with cross-functional teams, contribute high-level scientific expertise, and guide data-driven decisions from early research through regulatory submission. The role also involves mentoring and developing junior clinical pharmacologists.


Key Responsibilities

  • Develop and implement end-to-end clinical pharmacology and pharmacometric strategies to support programs from research through post-marketing.

  • Serve as the lead subject matter expert on PK/PD, quantitative pharmacology, biopharmaceutics, and drug–drug interaction assessments.

  • Advance small molecules and biologics through critical milestones, including IND/CTA, EOP2, and global marketing submissions.

  • Oversee or execute PK/PD and exposure-response analyses using advanced modeling and simulation tools to guide dose selection, trial design, human PK predictions, risk/benefit assessments, and regulatory strategy.

  • Collaborate with Clinical Development, Biostatistics, Toxicology, Discovery, DMPK, Translational Medicine, CMC, Regulatory and Operations teams to meet project and corporate objectives.

  • Drive scientific visibility through publications, presentations, and external collaborations.

  • Evaluate and integrate innovative modeling approaches to maintain cutting-edge pharmacometric capabilities.

  • Ensure adherence to SHE standards, GxP compliance, and regulatory guidelines across clinical pharmacology programs.


Supervisory Responsibilities

  • Mentor and potentially supervise 1–2 clinical pharmacology professionals.


Education & Experience Required

  • PhD or PharmD in Pharmaceutical Sciences, Pharmacology, or related discipline.

  • Minimum 8 years of clinical pharmacology and pharmacometrics experience within the pharmaceutical or biotechnology industry.

  • Proven experience in small and/or large molecule development, including contributions to IND, NDA, BLA, and global regulatory submissions.

  • Preferred experience in Oncology, translational science, and precision medicine initiatives.


Technical Knowledge & Skills

  • Strong expertise in clinical and quantitative pharmacology principles.

  • Proficiency in modeling and simulation platforms such as NONMEM, R, and other pharmacometric tools.

  • Hands-on experience with population PK, mechanistic PK/PD, PBPK, and disease modeling.

  • Comprehensive understanding of current regulatory expectations for nonclinical and clinical pharmacology.

  • Excellent communication skills with the ability to clearly convey technical concepts.

  • Demonstrated ability to influence development decisions using quantitative insights.

  • Ability to operate effectively in a matrixed, fast-paced environment.

  • Working knowledge of GLP and GCP regulations.

  • Strong problem-solving skills and a track record of delivering innovative solutions.


Work Environment

Exelixis offers a modern, collaborative workspace designed to support productivity and innovation. Teams work in an open environment with ergonomic setups and tools that enable seamless collaboration.


Compensation & Benefits

The compensation structure reflects U.S. market variations.

  • Base Salary Range: USD $183,000 – $259,500 annually, dependent on geographic region, experience, and internal equity.

  • Comprehensive benefits include:

    • 401(k) with company contributions

    • Medical, dental, and vision insurance

    • Life and disability coverage

    • Flexible spending accounts

    • Annual discretionary bonus opportunities

    • Employee stock purchase program and long-term incentives

    • 15 vacation days in the first year

    • 17 paid holidays, including winter shutdown

    • Up to 10 sick days annually


Equal Opportunity Statement

Exelixis is an Equal Opportunity Employer committed to maintaining a workplace free from discrimination based on race, color, gender, age, religion, national origin, sexual orientation, gender identity, disability, veteran status, or any other protected category.


Disclaimer

This job description outlines the general scope of responsibilities and qualifications and is not an exhaustive list of all duties associated with this role.