Associate Director – T&D Technical Services
Guidehouse
Director, Clinical Pharmacology – Pharmacometrics
MapLight Therapeutics, Inc.
full-time
Posted on:
Location Type: Hybrid
Location: Burlington • California, Massachusetts • 🇺🇸 United States
Visit company websiteJob Level
Lead
About the role
- 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
Requirements
- PhD degree 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
- Recent PK and PK/PD modelling skills using NONMEM
- Experience with MIDD paired meeting program
- Excellent communication and presentation skills
- Excellent publication record
Benefits
- Equal opportunity employer
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
PharmacokineticsPharmacodynamicsDrug MetabolismPK/PD modellingNONMEMclinical drug developmentclinical study designdata analysisscientific justificationregulatory submissions
Soft skills
communicationpresentationteam collaborationinterpersonal skillsanalytical thinkingproblem-solvingattention to detailorganizational skillstime managementleadership
Certifications
PhD in Pharmaceutical Sciences
