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Merck · 1 month ago

Director, Quantitative Pharmacology and Pharmacometrics – Oncology

United States

Full-time

Remote

Director/Executive

$191K/yr - $300K/yr

7+ years exp

Merck is seeking an experienced scientist to serve as Director within its Quantitative Pharmacology and Pharmacometrics–Immune/Oncology team. The role leads quantitative drug development strategies, model-based analyses, regulatory activities, and collaboration with cross-functional teams for oncology drug programs.

BiotechnologyHealthcarePharmaceuticalHealth CareMedical

Comp. & Benefits

H1B Sponsored

Responsibilities

Serving as an expert representative for QP2 -IO on Oncology development teams

Framing critical questions and strategy for optimizing model-based analyses on programs

Developing and executing model-based analyses including translational PK/PD approaches, population pharmacokinetic models, exposure-response models, clinical trial design simulation, disease progression models, quantitative systems pharmacology (QSP) modeling, and comparator modeling

Strategizing and executing modeling of tumor size and survival. A

Maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics in Oncology, authoring regulatory documents (investigational new drugs/INDs, clinical study reports (CSRs), clinical trial applications (CTDs), and representing QP2-IO at regulatory meetings

Mentoring and/or supervising junior staff to perform the above duties and to develop the above capabilities

Qualification

PharmacometricsClinical PharmacologyOncology Drug DevelopmentPharmacokinetic/Pharmacodynamic (PK/PD) ModelingPopulation Pharmacokinetic ModelingExposure-Response ModelingQuantitative Systems Pharmacology (QSP) ModelingClinical Trial Design SimulationStatistics and BiostatisticsRegulatory Submissions (IND/NDA)RNONMEMMATLABMonolixProgram LeadershipStakeholder Relationship Management

Required

Ph.D. with at least seven years of pharmaceutical drug development experience relating to: PKPD, pharmacometrics, mathematics, statistics/ biostatistics, or chemical/biomedical engineering

Masters or PharmD, with at least nine years of experience, where “experience” means having a record of increasing responsibility and independence in a similar role in pharmaceutical drug development

Demonstrated impact with applications of pharmacometrics methods

Experience in IND, NDA and other submissions to global regulatory agencies

Skills in experimental design, mathematical problem solving, critical data analysis/interpretation, and statistics

An exemplary record of increasing responsibility, independence, and demonstrated impact in driving drug development decisions through application of model-based approaches

Proficiency in R, NONMEM,MATLAB, Monolix or other modeling software

Professional working proficiency in written and verbal communication

Clinical Pharmacology, Communication, Data Modeling, Data Visualization, Drug Development, Modeling Software, Pharmacology, Pharmacometrics, Program Leadership, Stakeholder Relationship Management

Preferred

Antibody Drug Conjugates (ADC), Biologics, Oncology, Small Molecule Drugs, T Cells

Benefits

Eligible for annual bonus and long-term incentive, if applicable.

Medical, dental, vision healthcare and other insurance benefits for employee and family.

Retirement benefits, including 401(k).

Paid holidays.

Vacation.

Compassionate and sick days.

The remote position is applicable for those that are not within commutable distance to primary sites noted in posting. If commutable, the position will be hybrid.