ClinLab Solutions Group · 1 week ago
Senior Director, Clinical Pharmacology
Watertown, MA
Full-time
Onsite
Director/Executive
$250K/yr - $300K/yr
10+ years expClinLab Solutions Group is seeking a Senior Director of Clinical Pharmacology to lead the design and execution of clinical pharmacology programs. This role involves overseeing studies for clinical trials, collaborating with various teams, and ensuring data quality for regulatory submissions.
BiotechnologyRecruitingStaffing Agency
Responsibilities
Lead the design, implementation, and execution of clinical pharmacology strategies across our client's portfolio to support IND, first-in-human, proof-of-concept, and registrational studies
Develop, execute and convey to leadership clinical pharmacology plans, including PK/PD modeling, dose selection, and exposure–response analyses, and population pharmacokinetic analysis
Oversee collection, processing, and analysis of patient samples across all clinical programs to ensure data quality and scientific integrity
Partner with Drug Metabolism and Pharmacokinetics, Translational Medicine, Toxicology, and Biomarkers teams to design and interpret clinical studies supporting mechanism of action, safety, and efficacy
Provide scientific and operational oversight for bioanalytical assay development, validation, and sample testing conducted at internal and external laboratories
Ensure high-quality data ingestion and integration of pharmacology and biomarker datasets to support clinical decision-making and regulatory submissions
Represent Clinical Pharmacology in cross-functional program teams, contributing to protocol design, statistical analysis plans, and regulatory documentation
Lead preparation of key sections of clinical study reports, investigator brochures, and regulatory filings (IND, NDA, BLA)
Provide scientific input and defend clinical pharmacology strategies in interactions with regulatory authorities
Qualification
Required
PhD, PharmD, or MD in Pharmacology, Pharmaceutical Sciences, or a related discipline
10+ years of clinical pharmacology experience in the biotech or pharmaceutical industry, including leadership roles in clinical-stage development
Demonstrated expertise in clinical pharmacology strategy, study design, and regulatory interactions from early development through registration
Deep understanding of PopPK, PK/PD principles, modeling and simulation, and exposure–response analysis
Proven experience overseeing patient sample management, bioanalytical testing, and assay validation
Strong cross-functional leadership and ability to integrate complex scientific data into strategic development decisions
Excellent communication skills, with the ability to present to senior leadership and external stakeholders
Preferred
Oncology experience
Company
ClinLab Solutions Group
ClinLab Solutions Group is one of the only scientific resourcing firms that seamlessly supports the entire lifecycle — from early discovery through clinical development to commercialization.
201-500 employees
Funding
Current Stage
Growth StageLeadership Team
Steve Naclerio
Executive Vice President, Operations
Adam Katz
EVP of People & Development
Company data provided by crunchbase