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Executive Director, Quantitative Pharmacology and Pharmacometrics

$231.9k - $365k

Merck & Co.

Job Summary Team Leader (Executive Director) – Quantitative Pharmacology & Pharmacometrics (QP2) Department. Lead the immunology portfolio to advance model‑informed decision‑making from discovery through life‑cycle management. Primary Responsibilities Lead a team of up to 7 QP2 scientists, providing people management, scientific and operational oversight. Apply end‑to‑end drug discovery/development and disease area expertise to deliver day‑to‑day scientific oversight. Maintain a comprehensive understanding of global regulatory expectations and shape the clinical pharmacology regulatory strategy for selected immunology assets; prepare high‑quality regulatory documents (INDs, CSRs, CTDs). Develop and scale enabling modeling platforms (disease, mechanistic, comparator models) to differentiate the immunology portfolio. Implement quantitative clinical pharmacology, pharmacometrics and translational modeling to streamline drug discovery and development strategies. Act as a QP2 expert representative in cross‑functional and governance discussions, including business development and licensing evaluations. Set priorities for direct reports and drive performance management, hiring, retention, staff development and training. Collaborate with the Therapeutic Area Head to identify resource needs and contribute to internal resource allocation. Foster a culture of collaboration and high performance within the team. Education Ph.D./PharmD or equivalent degree with at least 12 years of experience, having a record of increasing responsibility and independence in pharmaceutical drug development or regulatory roles. Required Experience and Skills Background in biopharmaceutics, pharmaceutical sciences, pharmacometrics, chemical/biomedical engineering, computational biology, or related field. Profound knowledge of the immunology therapeutic area and translational science. Demonstrated experience in regulatory strategy for immunology, including independent authorship and defense of regulatory filings for marketing authorization (NDA/MAA). Extensive experience in developing quantitative strategies that influence pipeline decisions across different phases, including complex modalities. Strong understanding of functional deliverables in drug R&D and ability to link QP2 contributions to broader activities. Proven leadership of interdisciplinary teams or taskforces, with a track record of driving results through others. Ability to operate in an inclusive, high‑performance work environment and manage ambiguity. Excellent written and verbal communication, interdisciplinary collaboration, and problem scoping and planning. Preferred Experience and Skills Expertise in mechanistic modeling and/or population PK/PKPD analyses using standard software (e.g., MATLAB, NONMEM, R, Monolix, Phoenix). Scientific understanding of biopharmaceutical and ADME properties across modalities. Record of applying mechanistic models to inform decisions. Recognition as a leader in quantitative pharmacology, evidenced by publications, presentations, and involvement in professional organizations. Required Skills Clinical pharmacology, immunology, informed decision making, people management, pharmacometrics, regulatory submissions, stakeholder relationship management, strategic planning. Benefits We offer a comprehensive benefits package that includes medical, dental, vision, health‑care and other insurance benefits, retirement benefits (401(k)), paid holidays, vacation, and compassionate and sick days. Additional benefit details are available at Salary Range $231,900.00 – $365,000.00. Eligibility for annual bonus and long‑term incentive, where applicable. Equal Employment Opportunity Statement We are an Equal Employment Opportunity Employer and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other legally protected characteristics. For more information about personal rights under U.S. Equal Opportunity Employment laws, visit the U.S. Equal Employment Opportunity Commission (EEOC) website. #J-18808-Ljbffr Merck & Co.

Vacancy posted 4 days ago
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