*Dear All,*
Our team is currently working with several clients across the U.S. who are actively building or expanding their Clinical Pharmacology groups, and we are pleased to share these exciting opportunities with you! Please reach out to Jay Chapman at [email protected] if you're interested in learning more. Below is a brief overview of the available positions. *Associate Director, Clinical Pharmacology* *Location: *Massachusetts (hybrid) *The Role* - We’re seeking a highly motivated clinical pharmacologist to lead programs in the CNS therapeutic area. This role will serve as the Clinical Pharmacology Lead, guiding dose selection, trial design, and model-informed strategies across development stages. *Key Responsibilities* - Lead clinical pharmacology strategy, including trial design, PK/PD modeling, and dose optimization. - Perform and oversee NCA, population PK/PD, exposure-response analysis, and simulations. - Contribute to regulatory documents and represent Clinical Pharmacology in agency interactions. - Collaborate cross-functionally with DMPK, regulatory, clinical, and chemistry teams. - Promote model-informed development through publications and presentations. *Job Requirements* - Ph.D. or Pharm.D. in Pharmaceutical Sciences, Pharmacometrics, or related field. - 6-8 years of experience in the pharmaceutical industry. - Strong background in PK/PD modeling, ADME, and CNS drug development. - Proficiency with tools such as NONMEM, R, Monolix, WinNonlin, or similar. - Experience in regulatory submissions (IND, NDA) and direct FDA interaction. - Excellent leadership, communication, and cross-functional collaboration skills. ***************** *Associate Director, Clinical Pharmacology* *Location: *Massachusetts (hybrid) *The Role* - We’re looking for an experienced clinical pharmacologist to support RNAi-based CNS therapies. This role leads clinical pharmacology efforts, including PK/PD analysis, study design, and regulatory support, while working independently within a cross-functional, matrixed environment. *Key Responsibilities* - Serve as Clinical Pharmacology lead across clinical-stage projects. - Conduct and interpret PK and PK/PD analyses to inform development. - Contribute to protocols, study reports, and regulatory submissions (IND, CTA, NDA). - Collaborate with Research, Bioanalytical, Clinical, Regulatory, and other functions. - Support publications through abstracts and manuscripts. *Job Requirements* - Ph.D. or Pharm.D. in Clinical Pharmacology, Pharmacometrics, or related field. - Atleast 5 years’ experience in pharmaceutical/biotech industry. - Extensive industry experience in clinical pharmacology, PK/PD, and ADME. - Proficiency with WinNonlin, NONMEM, R, or similar tools. - Strong understanding of international regulatory guidelines. - Excellent communication, presentation, and collaboration skills. - Ability to work independently in a fast-paced, matrixed environment. ***************** *Director of Clinical Pharmacology* *Location: *NJ (Hybrid 3 days on site/possible remote) *The Role* - The Director, Clinical Pharmacology will lead clinical pharmacology strategies to support the development of drug candidates across all phases. This role involves oversight of PK/PD study design, dose selection, regulatory documentation, and cross-functional collaboration, with a strong emphasis on early-phase development and pharmacometric analyses. *Key Responsibilities* - Lead the design, execution, and interpretation of PK/PD studies across all clinical phases. - Serve as Clinical Pharmacology lead on project and study teams. - Drive dose selection strategies for Phase 1–3 trials. - Conduct or oversee PK/PD and population modeling analyses. - Contribute to clinical protocol development, study reports, and regulatory filings (INDs, NDAs, IBs). - Collaborate with preclinical, clinical, regulatory, and biostatistics teams. - Participate in Phase 1 CRO selection and provide scientific oversight. - Mentor junior team members and support due diligence activities. *Job Requirements* - Ph.D. or Pharm.D. in Pharmaceutical Sciences or related field. - 7+ years of industry experience in clinical pharmacology, PK/PD, and pharmacometrics. - Demonstrated leadership in clinical pharmacology programs; oncology experience preferred. - Proficiency with pharmacometric tools such as NONMEM and R. - Strong verbal and written communication skills. - Ability to work independently and thrive in a cross-functional, matrixed environment.
