Director, Pharmacometrics

Director Pharmacometrics, Quantitative Pharmacology and Pharmacometrics

The following information provides an overview of the skills, qualities, and qualifications needed for this role.

The Quantitative Pharmacology and Pharmacometrics (QP2) department drives model-informed drug discovery and development (MIDD) to 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 Director to drive pipeline impact and mentor / coach a talented group of pharmacometricians.

The Director-Pharmacometrics will work with scientists within QP2 by proactively evaluating and incorporating advanced pharmacometrics capabilities like comparator modeling, model-based meta-analysis (MBMA), and clinical trial simulations (CTS) into programs and thereby strengthening our pharmacometric capabilities on a continuous basis in decision-making and driving pipeline impact.

The Director will have the ability to independently develop and deploy comparator models across different therapeutic areas.

In addition, the individual will be accountable for coaching / mentoring talented pharmacometricians with diverse backgrounds to drive portfolio impact.

Directors (Pharmacometrics) are expected to provide expertise in one or more of the pharmacometrics capabilities through the following responsibilities :

• Responsible for achieving results on major program deliverables by identifying, driving the development, and implementation of one or more novel quantitative approaches that seek to improve cycle time, cost / size, number of trials, clinical trial design, and Go / No-Go decisions
• Serve as a subject matter expert and foster collaboration within QP2 and across functions to plan and execute novel analyses such as MBMA for informed decision-making on programs
• Mentor and / or supervise junior colleagues to perform the above duties and to develop the above capabilities
• Leverage significant pharmacometric and subject matter expertise in a broad range of therapeutic areas, modalities, and stages of drug discovery / development to independently provide day-to-day coaching / guidance to individual contributors

Required Experience :

• A Ph.D. or equivalent degree with at least 7 years of experience OR a PharmD or equivalent degree with at least 9 years of experience OR an MS or equivalent degree with at least 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
• Extensive experience in performing pharmacometrics analyses such as MBMA and CTS using standard pharmacometric software (e.

g. NONMEM, R, Monolix, etc.)

• Deep expertise in pharmacometrics with the ability to understand how MIDD can drive portfolio and regulatory decisions
• Deep knowledge of drug development, pharmacokinetics, and pharmacology principles required

Preferred Experience :

• Experience in performing pharmacometric analyses such as population pharmacokinetics (PopPK), pharmacokinetic / pharmacodynamic models, exposure-response models using NONMEM, R, Monolix, etc.
• Proficiency in written and verbal communication, interdisciplinary collaboration, and problem scoping and planning
• Strong interpersonal skills that ensure teamwork and productive interactions among diverse personalities / areas of expertise
• Excellent communication Skills including the ability to effectively present complex data, development plans, and strategies to various audiences in both verbal and written form, steer and influence interpretations (including impact) and conclusions for reports and regulatory documents that are clear and concise
• Demonstrated external visibility in the field of pharmacometrics, through publications, presentations, and involvement in professional organizations
• Ability to participate in and to steer an interdisciplinary team, and to oversee the work of other scientists

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