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Triveni Bio · 1 day ago

Director, Clinical Pharmacology

Watertown, MA

Full-time

Onsite

Director/Executive

$230K/yr - $260K/yr

10+ years exp

Triveni Bio is breaking new ground in the identification of novel disease targets, focusing on precision medicine. As Director of Clinical Pharmacology, you will lead the design and execution of clinical pharmacology strategies across multiple programs, serving as a subject matter expert and collaborating with cross-functional teams to ensure compliance with regulatory standards.

BiotechnologyHealth CareMedicalTherapeutics

Responsibilities

Define and implement clinical pharmacology strategies across multiple programs

Lead PK/PD modeling, dose selection, and bioanalytical planning

Author and review clinical pharmacology sections of protocols, regulatory documents, and submissions

Collaborate with Clinical Development, Research, Regulatory Affairs, Biostatistics, and Clinical Operations to ensure integrated plans

Represent Clinical Pharmacology in governance committees and regulatory interactions

Oversee vendor management for bioanalytical and modeling activities

Ensure adherence to GCP, ICH guidelines, and all applicable regulatory requirements

Other duties as assigned

Qualification

Clinical PharmacologyPharmacokinetics (PK)Pharmacodynamics (PD)Biologics ExperienceRegulatory RequirementsVendor ManagementLeadership ExperienceCross-functional Team Management