Executive Director, Clinical Pharmacology

ClinLab Solutions Group; Lexington (MA); On-site; USD 190,000 - 270,000; Full time

Job summary

ClinLab Solutions Group in Lexington, MA seeks a senior leader to build its internal Clinical Pharmacology function, bringing PK/PD and ADA data to the fore and guiding regulatory strategy for biologics from preclinical to IND and beyond.

The role requires a PhD in Clinical Pharmacology (or MD/PharmD) with 12+ years of program leadership, deep biologics experience, and strong cross-functional collaboration skills to partner with development, regulatory, and biometrics teams.

Qualifications

• PhD in Clinical Pharmacology or MD/PharmD with relevant experience; 12+ years of progressive leadership.
• Strong hands-on experience with clinical and non-clinical PK/PD data interpretation and immunogenicity assessment.
• Experience leading biologics programs across early to late-stage development and regulatory submissions.

Responsibilities

• Provide strategic leadership in PK/PD and ADA data analysis across the portfolio.
• Guide dose selection, trial design, and regulatory strategy for biologics from preclinical to IND and beyond.
• Lead PK/ADA data interpretation across animal and human studies; integrate findings for decision-making.
• Author regulatory sections and collaborate cross-functionally with development, biometrics, and regulatory affairs.
• Define and build internal clinical pharmacology capabilities in partnership with external consultants during transition.

Skills

Clinical pharmacology

PK/PD analysis

Immunogenicity ADA/NAb

Biologics development

Regulatory strategy

Leadership

Executive communication

Education

PhD in Clinical Pharmacology

MD or PharmD with relevant experience

Job description

Our client is a commercial-stage biopharmaceutical company developing and commercializing novel therapies for diseases with significant unmet need, with a particular focus on cardiovascular indications and deep expertise in immunology and inflammation. The company's lead product is a first-and-only FDA-approved therapy for a rare, debilitating disease, delivering meaningful relief to patients who previously had no approved treatment option. The company is performing exceptionally well commercially, with strong revenue growth, and a growing pipeline that includes both later-stage and early-stage programs. This is a growing, well-resourced organization with a collaborative, patient-first, in-person culture.

About the Role

This position offers the opportunity to build the company's internal Clinical Pharmacology function from the ground up. Much of this work has historically been outsourced to consultants, and the company is now bringing this expertise in-house as part of its continued growth and pipeline expansion.

Responsibilities

• Provide strategic and scientific leadership in the analysis and interpretation of non-clinical and clinical pharmacokinetic (PK), pharmacodynamic (PD), and anti-drug antibody (ADA) data across the portfolio
• Guide dose selection, clinical trial design, and regulatory strategy for biologic therapies from preclinical development through IND and late-stage development
• Lead the analysis, interpretation, and integration of PK and ADA data from rodent, non-human primate (NHP), and clinical studies
• Interpret non-clinical PK and immunogenicity data to support first-in-human starting dose and escalation strategy
• Serve as the clinical pharmacology subject-matter expert on clinical study teams
• Assess the impact of immunogenicity (ADA, NAb) on PK, efficacy, and safety across clinical studies
• Author and review clinical pharmacology sections of regulatory documents, including INDs, BLAs, Clinical Study Reports (CSRs), and Investigator's Brochures
• Partner cross-functionally with Nonclinical & Clinical Development, Translational Medicine, Biometrics, Regulatory Affairs, and CMC
• Assess the existing work and structure supporting this function, and help define and build out the company's internal clinical pharmacology capabilities going forward, initially working alongside an experienced outside consultant during the transition

Qualifications

• PhD in Clinical Pharmacology, Pharmacokinetics, Pharmaceutical Sciences, Pharmacology, or a related discipline (MD or PharmD with relevant experience will also be considered)
• 12+ years of progressive experience with demonstrated program leadership, ideally at the Senior Director or Executive Director level

Required Skills

• Strong hands-on experience with clinical and non-clinical PK data interpretation, immunogenicity (ADA/NAb) assessment, and biologic drug development
• Experience across a broad portfolio of programs, from early-stage studies through Phase III
• Background in biologics (monoclonal antibodies, protein therapeutics) strongly preferred; experience in cardiovascular, rare disease, and/or inflammatory indications is a plus
• A mix of large and small biopharma experience is ideal; candidates with exclusively large pharma backgrounds have not been the strongest fit historically
• Comfort operating in a fast-paced, matrixed biotech environment, with the ability to both think strategically and roll up your sleeves on hands-on technical work
• Strong executive presence and communication skills, including experience presenting complex data to senior leadership
• Demonstrated experience building or leading a team