Director, Quantitative Pharmacology and Pharmacometrics - Oncology

We are seeking an experienced talented scientist to join the Quantitative Pharmacology and Pharmacometrics – Immune/Oncology (QP2-IO) team as a Director. The QP2-IO team is part of the Global Clinical Development organization and oversees clinical pharmacology and pharmacometrics of oncology drugs from post‑PCC to registration. Directors lead quantitative drug development with an integrated understanding of strategic elements of drug development, work closely with cross‑functional scientists to develop novel chemical entities, and create aligned quantitative frameworks to impact strategies and decisions of drug development teams. Primary Responsibilities Serve as an expert representative for QP2‑IO on oncology development teams. Frame critical questions and strategy for optimizing model‑based analyses on programs. Develop and execute 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. Strategize and execute modeling of tumor size and survival. Maintain a comprehensive understanding of global regulatory expectations for small molecules and biologics in oncology, author regulatory documents (INDs, CSRs, CTDs) and represent QP2‑IO at regulatory meetings. Mentor and/or supervise junior staff to perform the above duties and develop the required capabilities. Minimum Education Ph.D. with at least 7 years of pharmaceutical drug development experience in PK/PD, pharmacometrics, mathematics, statistics/biostatistics, or chemical/biomedical engineering; or Masters/PharmD with at least 9 years of experience and a record of increasing responsibility and independence. Required Experience 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. Proficiency in R, NONMEM, MATLAB, Monolix or other modeling software. Professional working proficiency in written and verbal communication. Required Skills Clinical Pharmacology Communication Data Modeling Data VisualizationDrug Development Modeling Software Pharmacology Pharmacometrics Program Leadership Stakeholder Relationship Management Preferred Skills Antibody Drug Conjugates (ADC) Biologics Oncology Small Molecule Drugs T Cells Remote Work The position is remote only for candidates who are not within a commutable distance to primary sites; if commutable, the role will be hybrid. Commute distance is less than 50 miles. Benefits and Compensation Salary range: $190,800.00 – $300,300.00. Eligible for annual bonus and long‑term incentive, if applicable. Comprehensive benefits including medical, dental, vision, other healthcare insurance, 401(k), paid holidays, vacation, and compassionate and sick days. Equal Employment Opportunity Statement We provide equal opportunities to all employees and applicants for employment 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 applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. EEOC Know Your Rights documentation is available for personal rights under U.S. Equal Opportunity Employment laws. #J-18808-Ljbffr MSD Malaysia