Associate Director of Clinical Pharmacology (Boston, MA)

The Associate Director of Clinical Pharmacology supports a growing clinical portfolio focused on TPD therapeutics, with responsibilities across clinical pharmacokinetics (PK), pharmacodynamics (PD), and overall clinical pharmacology strategy. This role is integral to phase 1 development and an active preclinical pipeline, providing key PKPD guidance to project teams and conducting analyses that inform dose selection and drug development decisions.
 

• Lead the analysis, interpretation, and reporting of clinical pharmacokinetic and pharmacodynamic data to guide development decisions.
• Conduct model-based analyses for dose escalation and selection in ongoing clinical studies.
• Integrate clinical and preclinical findings to inform development strategies and broader research initiatives.
• Provide PKPD input for regulatory documents, including IND, CTA, and NDA submissions.
• Design and oversee clinical pharmacology studies, ensuring data quality and relevance.
• Network with external consultants, CRO partners, and academic sites to address clinical pharmacology challenges.
• Prepare relevant documents or sections of clinical protocols, Investigator Brochures, and Clinical Study Reports for Clinical Pharmacology studies.
• Collaborate closely with internal teams, including Research, Bioanalytical, Clinical, Regulatory, and Project Management functions.

• PharmD or PhD in Pharmacokinetics, Pharmacology, Pharmaceutics, or related field with 4-6 years of pharmaceutical industry experience.
• Strong knowledge of PK/PD principles, ADME concepts, and clinical pharmacology.
• Proficiency in pharmacokinetic and modeling software, such as Phoenix WinNonlin, NONMEM, or R.
• Excellent communication, presentation, and interpersonal skills, with the ability to work in a fast-paced, matrixed team environment.

Department: Direct Clients
This is a full time position