Job Description

This role provides strategic leadership and scientific oversight to part of the cardiometabolic (CMD) therapeutic area (TA) portfolio in the department of Quantitative Pharmacology and Pharmacometrics (QP2). The Team Leader (Senior Director) is responsible for application of cutting-edge quantitative pharmacology and pharmacometrics strategies to propel the internal portfolio forward leveraging the full strength of the QP2 department. The CMD TA Team Leader will be tasked with overseeing a team of QP2 scientists, providing guidance in personnel management, scientific strategy, and operational execution, in addition to serving as QP2 lead on assigned projects. Reporting directly to the QP2 CMD Head and serving as their delegate when needed, the individual will collaborate closely with the QP2 CMD leadership team and broader organization to ensure consistent, high-value quantitative pharmacology contributions throughout the CMD portfolio from discovery through life cycle management.This role is also part of the extended QP2 leadership team and expected to bring leadership and active contributions to one or more business or talent facing workstreams. Senior Directors are recognized as scientific thought leaders that develop and implement translational PK/PD strategies, characterize clinical pharmacokinetics and pharmacodynamics, and shape regulatory strategy, dose selection and go/no-go decisions.

Responsibilities

• Leading a team of up to 4 QP2 scientists including people management, scientific and operational oversight, under the direction of the Executive Director of QP2- CMD

• Leveraging end-to-end drug discovery/development and disease area expertise to independently provide day-to-day scientific oversight to individual contributors

• Setting priorities for direct reports and driving performance management, hiring and retention, staff development and training, and input into calibration and talent management processes

• Serving as an expert representative for QP2 on discovery and drug development teams and engaging in cross-functional and governance discussions, including business development and licensing evaluations

• Maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics, contributing to cross-functional regulatory strategy, authoring regulatory documents (INDs, CSRs, CTDs)

• Developing and applying mechanistic, disease progression and comparator modeling platforms to help drive portfolio decisions

• In partnership with Executive Director of CMD, identify resource needs and contributes to resource allocation internally.

• Serve as QP2 lead on assigned projects

Required:

• Ph.D./PharmD or equivalent degree with at least 10 years of experience where 9experience9 means having a record of increasing responsibility and independence in a similar role in pharmaceutical drug development or regulatory.

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

• Extensive experience in developing quantitative strategies for impacting pipeline decisions, and drug development expertise

• Demonstrated ability to lead an interdisciplinary team or taskforce, and/or to oversee the work of others

• Record of ability to operate in an inclusive and high-performance work environment applying enterprise ways of working principles including fostering collaboration and driving results, while managing ambiguity

• Relevant regulatory and quantitative pharmacology experience

• Proficiency in written and verbal communication, interdisciplinary collaboration, and problem scoping and planning

Preferred:

• CMD Therapeutic area or disease knowledge

• Expert skills in performing population PK/PKPD analyses using standard pharmacometrics software (e.g. NONMEM, R, Monolix, Phoenix, etc.)

• Scientific understanding of biopharmaceutical and ADME properties across modalities

• Record of applying models to inform decisions

• Ability to influence regulatory strategies including prior experience independently authoring and defending regulatory filings for marketing authorization (NDA/MAA)

• Recognized leader in the field of quantitative pharmacology with a track record of sustained external visibility through publications, presentations and/or involvement in professional organizations

This opportunity will be hybrid or remote, but the remote position is only applicable for those that are not within commutable distance to primary sites noted in posting. If commutable, the position will be hybrid. Please note that standard commute is (less than) <50 miles."

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