Senior Director, Quantitative Pharmacology and Pharmacometrics

Merck & Co. • West Point, PA

234d • Remote

About The Position

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.

Requirements

• Ph.D. or equivalent degree with 12 years of experience 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)
• 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

Responsibilities

• Guide a team of approximately 5-10 pharmacometricians to achieve results on major program drivers by identifying and implementing quantitative approaches (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, remove 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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Chemical Manufacturing
• Education Level: Ph.D. or professional degree