Senior Director, Quantitative Pharmacology and Pharmacometrics

MSD; Rahway (NJ); On-site; USD 200,000 - 250,000; Full time

Job summary

An established industry player is seeking a Senior Director in Pharmacometrics to lead a talented team in driving innovative drug discovery and development strategies. This role offers the opportunity to shape the future of pharmacometrics by guiding a dedicated team of professionals, implementing cutting-edge quantitative approaches, and fostering collaboration across departments. The ideal candidate will possess extensive experience in pharmacometrics and a strong educational background, enabling them to influence key decisions that impact drug development and regulatory approvals. Join a forward-thinking organization that values innovation and excellence in driving impactful results.

Qualifications

• Ph.D. with 12+ years in pharmaceutical drug development or academia.
• Deep expertise in pharmacometrics and quantitative strategies.

Responsibilities

• Guide a team of pharmacometricians to implement quantitative approaches.
• Foster collaboration and evaluate quality systems for QP2.

Skills

Pharmacometric Analysis

Model-Informed Drug Development

Team Leadership

Quantitative Approaches

Interpersonal Skills

Education

Ph.D. in Pharmacometrics or related field

Tools

Modeling and Simulation Tools

Job description

Job Description

Location:

• WP or RY

The Quantitative Pharmacology and Pharmacometrics (QP2) department drives model-informed drug discovery and development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced leadership team, deep modeling expertise, and state-of-the-art modeling approaches across multiple therapeutic areas and modalities to drive portfolio impact from discovery through life-cycle management. The team is externally visible and continues to be at the leading edge of building innovative state-of-the-art tools. With MIDD as an essential component of decision-making at our Company, this position offers an opportunity for the Pharmacometrics leader to drive pipeline impact and lead a talented group of pharmacometricians.

This Senior Director is expected to be an experienced pharmacometrician with a strong understanding of the integrated strategic elements of drug discovery and development and the ability to incorporate Modeling and Simulation (M&S) tools in decision making to drive pipeline impact. She/he will take on primary responsibilities for identifying emerging areas of pharmacometrics innovation and leading QP2 efforts to strengthen our pharmacometrics capabilities on a continuous basis. The Senior Director will be accountable for directing a team of pharmacometricians with diverse backgrounds and bringing subject matter expertise related to model-informed drug discovery and development for programs.

The Senior Director in Pharmacometrics should provide strategic leadership for pharmacometrics through the following responsibilities:

• Guide a team of approximately 5-10 pharmacometricians to achieve results on major program drivers by identifying and implementing quantitative approaches (for e.g., translational PK/PD models, population pharmacokinetic models, exposure-response models, quantitative system pharmacology (QSP) and disease progression models, clinical trial simulations, comparator modeling) that seek to improve cycle time, cost/size and number of trials, implementation of tools and framework for driving Go/No Go decisions on programs and rapid regulatory approvals.

• Foster collaboration within QP2 to achieve results, removing barriers on portfolio or scientific priorities.

• Evaluate and maintain appropriate quality systems and IT infrastructure for QP2 to support emerging capabilities.

• Responsible for priority-setting, performance management, hiring and retention, talent development/management for direct reports.

• Identify resource needs and contribute to resource allocation internally and through management of business operations and outsourcing budgets.

• Provide functional representation on committees, task forces or initiatives spanning beyond QP2.

• Initiate and manage external collaborations to develop new methodologies and lead our external outreach to the scientific pharmacometrics community.

Required Experience:

• (a Ph.D. or equivalent degree with ≥ 12 years of experience where “experience” means having a record of increasing responsibility and independence in a similar role in pharmaceutical drug development or academia.

• Educational background in pharmacometrics, pharmaceutical sciences, mathematics, statistics/biostatistics, computational biology/chemistry, chemical/biomedical engineering, or a related field.

• At least 10 years of discovery/drug development/regulatory experience.

• Deep expertise in pharmacometrics (e.g., population PK and PK/PD analyses, model-based meta-analysis, dose-response and exposure-response analyses, disease modeling, trial simulation, optimal study designs, strategic decision analyses, economic modeling) with the ability to understand how MIDD can drive portfolio and regulatory decisions.

• Extensive experience in developing quantitative strategies for impacting pipeline decisions.

• Good interpersonal and communication skills that ensure teamwork and productive interactions among diverse personalities/areas of expertise.