Associate Director of Clinical Pharmacology (Boston, MA)

Associate Director of Clinical Pharmacology (Boston, MA)

Summary: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.Key Responsibilities: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.Qualifications: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 ClientsThis is a full time position

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