Director, Pharmacometrics

Job Description

The Quantitative Pharmacology and Pharmacometrics (QP2) department drive 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 director will be part of a leadership team responsible for applying traditional and state-of-the-art pharmacometric approaches on the portfolio and continue to innovate our pharmacometrics capabilities on a continuous basis. The 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 Director in Pharmacometrics should provide strategic leadership for pharmacometrics through the following responsibilities:

• Guide a team of approximately 5-6 pharmacometricians to achieve results on major program drivers by identifying and implementing novel quantitative approaches (for e.g., comparator modeling, clinical trial simulations,  quantitative system pharmacology (QSP) and disease progression models, artificial intelligence algorithms, machine learning methods) that seek to improve cycle time, cost/size and number of trials, implementation of tools and regulatory framework for rapid approvals and driving Go/No Go decisions on programs

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

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

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

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

Required Experience:

• a Ph.D. or equivalent degree with 7+ years of experience OR a PharmD or equivalent degree with 9+ years of experience) OR an MS or equivalent degree with 11+ 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. 

• 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, artificial intelligence algorithms, machine learning methods) with ability to understand how MIDD can drive portfolio and regulatory decisions

• Deep knowledge of drug development, pharmacokinetics and pharmacology and basic science skills required

Preferred Experience:

• Extensive experience in developing quantitative strategies for impacting pipeline decisions

• Drug development and regulatory experience agnostic of therapeutic area, including a record of PMx impact in driving model-informed drug development strategies across programs

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

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