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Merck · 13 hours ago

Group Leader - Senior Director, Quantitative Pharmacology and Pharmacometrics (Hybrid or Remote)

Rahway, NJ

Full-time

Hybrid

Director/Executive

$210K/yr - $331K/yr

10+ years exp

Merck is a leading pharmaceutical company seeking a Senior Director for their Quantitative Pharmacology and Pharmacometrics department. This role involves providing strategic leadership and scientific oversight in the cardiometabolic therapeutic area while managing a team of QP2 scientists and contributing to drug development projects.

BiotechnologyHealth CareMedicalPharmaceutical

Comp. & Benefits

H1B Sponsored

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

Qualification

Quantitative PharmacologyPharmacometricsRegulatory StrategiesDrug DevelopmentClinical PharmacologyData ModelingStakeholder Relationship ManagementTeam ManagementStrategic LeadershipData ScienceData VisualizationDose Response AnalysisPharmaceutical SciencesProduct ApprovalsCardiometabolic

Required

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, 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