Associate Director, Clinical Pharmacology
- Cambridge, MA
- Employees can work remotely
- Department: Research & Development
- Region: US
The Associate Director of Clinical Pharmacology and Pharmacometrics serves as the clinical pharmacology lead on program, clinical and study teams, providing strategic leadership and execution of clinical pharmacology plans for drug candidates. He/she will integrate knowledge of pharmacokinetics, pharmacodynamics, patient characteristics and disease states to optimize doses, dosage regimens and study designs throughout clinical drug development.
Responsible for drafting and executing clinical pharmacology development plans and providing clinical pharmacology expertise to program and clinical teams.
- Leads clinical pharmacology study efforts (e.g. study design, protocol preparation, clinical phase oversight and reporting). Analyzes and interprets results and recommends action based on study results.
- Directs planning of all relevant PK-PD analyses; performs or guides such analyses as appropriate. Works to ensure population PK, PK-PD modeling and simulation, meta-analysis, etc. are integrated into the development plan
- Responsible for appropriately summarizing, modeling and interpreting results of pharmacokinetic/pharmacodynamics analyses with respect to their impact on development and clinical use of drugs.
- Supports regulatory strategy for filings and is responsible for clinical pharmacology sections of regulatory documents. Contributes or leads the resolution of clinical pharmacology queries from regulatory agencies, takes a lead role in writing and reviewing responses to regulatory queries.
- Maintain current knowledge of literature, government guidelines, and internal guidance to be a team resource of clinical pharmacology knowledge in terms of both therapeutic area background and clinical trial design
- Demonstrates an understanding of 1) PK/PD principles, physiology, pharmacology and pathology; 2) operational and scientific aspects of early development studies; and 3) quantitative analysis.
- Ability to generate development strategies, design clinical pharmacology studies and analyze PK/PD data utilizing sound scientific principles. Ability to relate clinical pharmacology to the broader development paradigm.
- Understanding and ability to apply appropriate regulatory and ICH guidelines in the design, analysis and interpretation of clinical pharmacology studies
- Excellent oral and written communication skills for effective interactions in various environments including, but not limited to multidisciplinary teams, regulatory agencies, scientific symposia, advisory boards
- PhD or MD/PhD in Pharmacology, Pharmacokinetics, Pharmaceutics or PharmD or other suitable related fields
- 5+ years relevant industry experience (clinical pharmacology and/or clinical PK/PD)
- Experience with use of PK/PD software packages such as -Phoenix WinNonlin, SimCYP, NONMEM, Monolix, R, Adapt, MATLAB, SAS
All your information will be kept confidential according to EEO guidelines.