Associate Clinical Pharmacology & Pharmacometrics Director
Location: Global | Multiple Regions
Industry: Biopharmaceuticals | Drug Development | Clinical Research
Job Summary
The Associate Clinical Pharmacology & Pharmacometrics Director is a scientific and strategic leader responsible for driving clinical pharmacology and quantitative pharmacology (PK/PD and modeling & simulation) activities across key drug development programs. This role supports early-stage through post-marketing development and provides expert guidance to multidisciplinary project teams. The position requires strong technical depth, cross-functional collaboration, and proven experience in clinical pharmacology and translational science.
This opportunity is ideal for candidates who excel in fast-paced, matrixed environments and can influence critical decisions in clinical strategy, dose optimization, regulatory interactions, and program execution.
Key Responsibilities
Develop and execute clinical pharmacology and pharmacometrics strategies supporting research, clinical development, and post-marketing programs.
Serve as the clinical pharmacology/pharmacometrics lead on project teams, providing expertise in PK/PD, biopharmaceutics, drug-drug interactions, and quantitative pharmacology.
Advance small molecules and biologics through major development milestones including IND/CTA submissions, EOP2 meetings, and marketing applications.
Perform PK/PD and exposure-response analyses using state-of-the-art modeling and simulation tools to guide dose selection, study design, benefit-risk assessments, Go/No-Go decisions, regulatory strategies, and publications.
Collaborate closely with Clinical Development, Biostatistics, Discovery, Translational Medicine, CMC, Toxicology, DMPK, Clinical Operations, and Regulatory Affairs.
Engage internal and external experts to evaluate new technologies and methodologies, ensuring continuous enhancement of modeling and simulation capabilities.
Ensure adherence to global regulatory standards, GxP compliance (GLP/GCP), and corporate safety policies.
Supervisory Responsibilities
This role currently has no direct supervisory responsibilities, but requires strong leadership, influence, and cross-functional guidance.
Required Education & Experience
Minimum Education
PhD or PharmD in Pharmaceutical Sciences, Pharmacology, or a related discipline, plus at least 5 years of relevant experience, or
An equivalent combination of advanced education and professional experience.
Required Professional Experience
Minimum 5 years of clinical pharmacology and/or pharmacometrics experience within the pharmaceutical or biotechnology industry.
Experience supporting development of small molecules and/or biologics.
Demonstrated contributions to translational science and precision medicine initiatives.
Key Knowledge, Skills & Abilities
Deep understanding of clinical and quantitative pharmacology principles.
Hands-on modeling and simulation expertise using NONMEM, R, and other M&S software.
Strong knowledge of global regulatory guidelines governing clinical pharmacology.
Excellent written and verbal communication skills with the ability to convey complex scientific concepts clearly.
Proven ability to collaborate effectively in highly matrixed, cross-functional environments.
Strong scientific leadership and the ability to influence strategy and decision-making.
Demonstrated problem-solving capabilities, with the ability to address complex development challenges.
Applied knowledge of GLP and GCP requirements.
Work Environment
The work setting supports innovation, collaboration, and productivity. The organization provides modern, open office spaces equipped with ergonomic setups, professional tools, and resources that encourage creativity and teamwork.
Compensation & Benefits
Compensation is aligned with labor market variations across U.S. geographic regions.
Base Salary Range: USD $158,000 – $224,500 annually
Actual compensation will vary based on geographic location, experience, and internal equity.
Additional benefits include:
Comprehensive medical, dental, and vision coverage
401(k) with company contributions
Life and disability insurance
Flexible spending accounts
Annual discretionary bonus eligibility
Employee stock purchase opportunities and long-term incentives
15 vacation days in the first year
17 paid holidays, including a company-wide winter shutdown
Up to 10 sick days annually
Equal Opportunity Statement
The employer is an Equal Opportunity organization and does not discriminate based on race, color, sex, age, national origin, religion, sexual orientation, gender identity, veteran status, disability, or any legally protected classification.
Disclaimer
This job description outlines the general nature and responsibilities of the role and is not intended to be an exhaustive list of all duties and qualifications associated with the position.
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