ABOUT CRITICAL PATH INSTITUTE (C-PATH)

Critical Path Institute (C-Path) is a nonprofit engaged in the creation of partnerships and innovative processes that improve human health by reducing the time, cost, and risk in developing and approving new therapies. For twenty years, we have partnered with industry and academic experts to advance technologies across the spectrum of medical product development from research to regulatory approval. As a leading nonprofit organization dedicated to fostering collaboration and promoting data sharing in the precompetitive space, C-Path has been at the forefront of numerous advances designed to get new treatments to patients quicker. Our continuing success is made possible by a combination of public and private support from those who share our vision to accelerate a path to a healthier world.

POSITION OVERVIEW

This director will work closely with clinicians, statisticians, and other scientists through C-Path's public- private-partnership model to create actionable plans that include assessments of endpoints, sources of variability, and analysis approaches for the subject-level data conducive to the development of quantitative drug development platforms and tools. This individual has primary responsibility for the clinical pharmacology and modeling and simulation components of the development plans.

SUPERVISORY RESPONSIBILITIES

• The Director will be responsible for the Pharmacometrics Team within the Quantitative Medicine Program.

CORE DUTIES/RESPONSIBILITIES

• Provide expertise in pharmacometrics as well as knowledge of best regulatory practices, compliant PK/PD and pharmacometrics data structures, and analysis methodology.

• Represent MIDD and Quantitative Medicine on cross-functional teams to provide modeling and simulation support to enable internal decisions and contributions towards regulatory filings.

• Plans and directs clinical pharmacology and modeling and simulation components of programs.

• Works with multifunction and internal and external teams to design, conduct, deliver and report the assigned clinical pharmacology and modeling and simulation tasks.

• Accountable for the development and implementation of modeling and simulation plans based on agreed upon best practices (i.e., model-based / model-informed drug development).

• Responsible for the use of quantitative methods to integrate knowledge of pharmacokinetics, pharmacodynamics, patient characteristics and disease status to inform optimization of doses, dosage regimen, and study designs.

• Responsible for appropriate summarization and interpretation of results of data analyses with respect to their impact on development of quantitative drug development tools.

• Prepares scientific summaries and reports, which will be used for regulatory interactions, submissions and publications.

• Provides quantitative medicine, clinical pharmacology support and leadership in the preparation and defense of regulatory submissions.

• Develop novel modeling and simulation methodology and establish new platforms to improve development timeline and efficiency.

REQUIRED KNOWLEDGE SKILLS AND ABILITIES

• Broad scientific, clinical, technical, and regulatory understanding of the functions involved in the development of pharmaceutical products.
• Demonstrated understanding PK principles, PK-PD and pharmacology relevant to quantitative drug development platforms.
• Knowledge of phase I-III studies; linear and non-linear mixed-effects models; parametric survival analyses; joint modeling for time-matched data; and model-based meta-analyses.
• Knowledge of FDA/EMA/PMDA regulations and requirements.
• Excellent time management skills with a proven ability to meet deadlines.
• Strong analytical and problem-solving.
• Ability to prioritize tasks and to delegate them when appropriate.
• Proficient with Microsoft Office Suite or related software.

REQUIRED EDUCATION AND EXPERIENCE

• A PharmD, PhD required.
• Prior experience in drug development (drug discovery, mechanistic pharmacology, safety assessment, clinical development, project management, or regulatory affairs in the pharmaceutical industry and/or FDA/EMA) required.
• Minimum 10 years related experience in strategy, planning, and project management with a preferred minimum of 5 years of industry experience.
• In-depth knowledge of multiple M&S techniques and multiple TAs required.
• Experienced in addressing comments/questions from regulatory agencies.
• Proficiency with NONMEM and R strongly preferred. Proficiency with other quantitative software such as Simcyp, Monolix, Phoenix WinNonLin, is preferred.
• A track record of scientific contributions through publications in the areas of Clinical Pharmacology and Pharmacometrics.
• Excellent verbal presentation and written communications skills in English.

Reasonable Accommodation:

C-Path is committed to providing an inclusive and accessible work environment. If you require a reasonable accommodation to complete any part of the application process, interview process, or to perform the essential functions of the position, please contact our Human Resources department. All requests will be handled confidentially and in accordance with applicable laws and regulations.

Critical Path Institute is an equal opportunity employer. Visit our website at www.c-path.org

The above statements describe the general nature and level of work only. They are not an exhaustive list of all required responsibilities, duties, and skills. Other duties may be added, or this description amended at any time.

Salary : $146,000 - $214,900