Director, Clinical Pharmacology & Pharmacometrics

MapLight Therapeutics•Burlington, MA

56d

About The Position

Who We Are: MapLight Therapeutics is a clinical stage biotech company that focuses on drug discovery for central nervous system disorders. We combine cutting-edge technologies including optogenetics, in vivo physiology, and spatial transcriptomics to identify novel drug targets and develop effective therapies to address psychiatric symptoms. Who We Are: MapLight Therapeutics is a clinical stage biotech company that focuses on drug discovery for central nervous system disorders. We combine cutting-edge technologies including optogenetics, in vivo physiology, and spatial transcriptomics to identify novel drug targets and develop effective therapies to address psychiatric symptoms. What You’ll Do: The Director of Clinical Pharmacology & Pharmacometrics will serve as both the Clinical Pharmacology and Pharmacometrics Lead for clinical programs. In this pivotal role, you will apply deep expertise in pharmacokinetics (PK), pharmacodynamics (PD), and quantitative modeling to guide dose selection and optimize the therapeutic index of investigational therapies throughout all stages of clinical development. You will be a key member of the Clinical Development organization, collaborating cross-functionally with teams in Clinical Operations, Biometrics, Regulatory Affairs, Medical Affairs, Toxicology, and Pharmacology to advance MapLight’s clinical portfolio.

Requirements

Ph.D. in Pharmaceutical Sciences or a related discipline.
Formal training in Pharmacokinetics, Pharmacodynamics, and Drug Metabolism.
Minimum of 6 years of experience in clinical drug development, preferably with small molecules.
Demonstrated expertise in PK and PK/PD modeling, including recent applications using NONMEM.
Strong scientific communication and presentation skills.
Proven publication record in the field of clinical pharmacology and pharmacometrics.

Responsibilities

As a core member of clinical program team, and as the clinical pharmacology and pharmacometrics lead provide strategic input into the progression of drug candidates from pre-IND through NDA submission.
Design and provide input into Phase 1–3 clinical study protocols, reports, and related clinical documentation.
Perform, interpret, and communicate PK and PD analyses to support dose selection and clinical decision-making.
Provide scientific rationale for dose selection and regimen optimization throughout clinical development.
Author and contribute to regulatory submissions and represent the company in interactions with global health authorities.