Senior Director, Quantitative Pharmacology and Pharmacometrics-Immunology

Merck • Boston, MA

19d • Hybrid

About The Position

This Team Leader (Senior Director) role provides strategic leadership and scientific oversight to part of the immunology therapeutic area portfolio that has been a strategic growth area for our Company during the last years. The Immunology Team Leader is responsible for application of cutting-edge quantitative and translational clinical pharmacology and pharmacometrics strategies to propel the internal portfolio forward leveraging the full strength of the QP2 department. The Immunology 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 Immunology Executive Director and serving as their delegate when needed, the individual will collaborate closely with the QP2 Immunology leadership team and broader organization to ensure consistent, high-value quantitative pharmacology contributions throughout the immunology 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.

Requirements

• Ph.D./PharmD or equivalent degree with at least 10 years of experience where “experience” means having a record of increasing responsibility and independence in a similar role in pharmaceutical drug development or regulatory
• Educational background in biopharmaceutics, pharmaceutical sciences, pharmacometrics, chemical/biomedical engineering, mathematics, computational biology, or a related field
• Immunology therapeutic area or disease knowledge
• 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

Nice To Haves

• Expert skills in performing population PK/PKPD analyses using standard pharmacometrics software (e.g., NONMEM, R, Monolix, Phoenix, etc.)
• Knowledge of quantitative strategies for complex modalities
• Scientific understanding of biopharmaceutical and ADME properties across modalities
• Record of applying mechanistic 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

Responsibilities

• Leading a team of approximately 4 QP2 scientists including people management, scientific and operational oversight, under the direction of the Executive Director of Immunology
• 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 drug development and discovery 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 insights portfolio decisions and inform biomarker strategies
• In partnership with Executive Director of Immunology, identify resource needs and contribute to resource allocation internally
• Serve as QP2 lead on assigned projects

Benefits

• The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
• We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Executive
• Education Level: Ph.D. or professional degree