STEMSourcing

Executive Director Clinical Pharmacology / Pharmacometrics Needed! This role will require you to be on site 3-4 days a week and you'll most likely need to relocate for the role. East Coast! Report directly to the VP of the group of 12 or so CP and Pmx scientists. Please contact me to learn more. telder@stem-sourcing.com This company has 30-40 assets in or approaching the clinic and is growing their team with new roles this year. Lead the pharmacometrics function within oncology and other therapeutic areas, providing scientific, technical, and strategic direction. Oversee the development and implementation of Model Informed Drug Development (MIDD) plans, including the planning and execution of quantitative analyses such as population pharmacokinetics, PK/PD, exposure-response, disease progression modeling, model-based meta-analysis, and decision analysis. Develop and conduct individual MIDD plans and analyses as needed. Work with / Manage a large team of pharmacometricians and/or other computational scientists. Train, develop, and mentor pharmacometricians and other MIDD colleagues. Forecast pharmacometrics resourcing needs within the oncology therapeutic area. Provide guidance on regulatory MIDD strategy. Contribute to the enhancement of tools, processes, and methodologies, participating in internal cross-functional workgroups, external alliances, committees, consortia, and academic collaborations. Influence and lead the external environment through participation in scientific societies, publications, presentations, and collaborations.

Associate / Director, Clinical Pharmacology & Pharmacometrics A growing group at a midsized pharma is expanding. Don't let your career be limited to just one area. This NEW role will encompass BOTH CP and Pmx. Scientists with less/more experience are encouraged to explore this role. Please message me to learn more telder@stem-sourcing.com Provide expert guidance in interpreting data from pharmacometric analyses, such as population pharmacokinetics (PPK) and exposure-response analyses. Recommend dosing paradigms for different phases of clinical development and justify dose selection for pivotal clinical trials. Proven track record of successful clinical development, including enabling clinical PK and clinical pharmacology analyses. Hands-on experience with PPK, exposure-response (ER), or physiologically-based pharmacokinetic (PBPK) analyses and reporting. Proficiency with tools such as NONMEM, R, SimCYP, GastroPlus, or similar software.

Jennifer Sass Young is #hiring. Know anyone who might be interested?

Our Client is seeking a highly skilled and experienced Senior Director of Pharmacometrics and Clinical Pharmacology to lead their efforts in early and late-stage clinical drug development (Phase 1-3). The successful candidate will be responsible for designing and implementing pharmacometric and clinical pharmacology strategies that ensure the successful development of innovative therapeutics. Develop and execute comprehensive pharmacometrics and clinical pharmacology strategies for Phase 1-3 clinical trials. Oversee the design, execution, and analysis of clinical pharmacology studies, including first-in-human (FIH), dose escalation, bioavailability, bioequivalence, and drug-drug interaction studies. Ensure timely and accurate interpretation of PK/PD data and its integration into clinical development plans. Lead the preparation of clinical pharmacology sections of regulatory submissions (INDs, NDAs, BLAs) and represent the company in regulatory interactions. Lead and mentor a team of pharmacometricians and clinical pharmacologists, fostering a collaborative and innovative work environment. Proven track record of leading pharmacometrics and clinical pharmacology efforts in the development of novel therapeutics, with successful regulatory submissions. Please message me to learn more telder@stem-sourcing.com

Does anyone plan to attend the Leap HR conference in Boston in August? Would love to connect and hear you thoughts if you have attended in the past!