GForce Life Sciences · 21 hours ago
Clinical Pharmacologist
Massachusetts, United States
Contract
Hybrid
Senior Level, Lead/Staff, Director/Executive
3+ years expGForce Life Sciences is seeking a highly motivated and experienced quantitative clinical pharmacologist to join their team. The role involves providing subject matter expertise in the CNS therapeutic area, supporting project teams with core scientific responsibilities related to dose selection and pharmacokinetic modeling.
ConsultingProject ManagementRecruiting
Hiring Manager
Jacqueline McLellan
Responsibilities
Contribute to clinical program design, trial protocols, analysis plans, study reports, and regulatory submissions
Conduct and oversee pharmacokinetic (NCA) analysis, exposure-response analysis, simulation-based trial design and dose selection, and population clinical pharmacology modeling
Present strategy and defend outcomes of model-based approaches to internal governance boards and regulatory agencies
Write or review clinical pharmacology components of regulatory documents and responses; participate directly in regulatory interactions
Promote model-informed drug discovery and development through external collaboration, journal publication, and conference presentation
Function effectively in a highly matrixed team environment
Serve as an active contributor on multi-disciplinary project teams, providing innovative and progressive input
Act independently within a highly matrixed clinical development organization and provide sound clinical pharmacology input to project teams
Qualification
Required
Ph.D. or PharmD in Pharmaceutical Sciences, Pharmacometrics, or related field with 3+ years or 4+ years of pharmaceutical industry experience
Demonstrated experience serving as a clinical pharmacology lead on development programs
Strong understanding of pharmacokinetic theory, compartmental modeling and simulation, and statistical approaches utilizing current computational tools
Working knowledge of cross-functional interfaces relevant to drug development and detailed understanding of non-clinical and clinical DMPK processes
Programming experience in Phoenix required; additional experience in Monolix, R, WinNonlin, SAS, or Splus is desirable
Current knowledge of FDA regulatory guidance related to nonclinical and clinical pharmacology; direct interaction with FDA including IND, NDA, and other submissions required
Experience in non-compartmental and model-based PK and PK/PD analyses and incorporating data into manuscripts, study reports, and regulatory submission documents (INDs, NDAs, CTDs)
Excellent interpersonal, leadership, communication, and time-management skills; demonstrated experience managing internal and external personnel (including outsourced projects)
Preferred
Clinical pharmacology experience with small molecules desired
Experience with pharmacokinetic/pharmacodynamic modeling, bioanalytical analysis, and nonclinical ADME desired
Knowledge and experience in CNS therapeutics desired
Hands-on modeling experience desirable
Company
GForce Life Sciences
GForce Life Sciences is a platform for career management that offers executive search, medical affairs consulting, and project management.
51-200 employees
H1B Sponsorship
GForce Life Sciences has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2024 (1)
2023 (1)
2022 (1)
Funding
Current Stage
Growth StageLeadership Team
Mark Gallagher
Founder & CEO
Company data provided by crunchbase