Director, Clinical Pharmacology, Pharmacometrics & Translational Sciences

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 & Translational Sciences will serve as a Clinical Pharmacology Lead for clinical studies. The successful candidate will play a critical role in shaping the clinical strategy by applying scientific expertise in PK and PD and utilizing quantitative tools to inform the dosing regimen that optimizes the therapeutic index of investigational drugs across all stages of clinical development. In this role you will work in the clinical development division and collaborate with colleagues across functions such as clinical, clinical operations, biometrics, regulatory, and medical affairs.

Responsibilities:

• Participate in clinical projects teams to move forward new drug candidates from pre-IND through submission
• Contribute to design of Phase 1, 2 and 3 studies and associated clinical documents and reports
• Analysis, interpretation, and reporting of clinical PK and PD results
• Responsible for scientific justification of clinical dose selections
• Contribute to regulatory submissions and interactions with Health Authorities

Qualifications:

• PhD in Pharmaceutical Sciences or related field.
• Trained in Pharmacokinetics, Pharmacodynamics and Drug Metabolism
• At least 5 years of experience in clinical drug development of small molecules
• PK and PK/PD modelling skills using software commonly used in the field of model-informed drug development (e.g. NONMEM, R, GASTROPLUS, Simcyp, Monolix)
• Excellent communication and presentation skills
• Excellent publication record

MapLight is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.