Our client is experiencing significant growth, and we are excited to support the build-out of their Quantitative Pharmacology organization. This newly created position will report directly to the Head of Quantitative Pharmacology. Position Summary Join one of the most advanced and respected Quantitative Pharmacology teams in the world. This company offers full O-1 visa sponsorship and will cover relocation to one of their three East Coast sites. This role will be approximately 40% hands-on at the Senior Director level and 75% hands-on at the Director level. The successful candidate will apply state-of-the-art modeling and simulation (M&S) methodologies to shape study designs, guide internal and external decision-making, and influence strategy across the development portfolio. A key expectation is to build and implement quantitative frameworks that drive model-informed drug discovery and development, while also ensuring scientific rigor through mentorship and leadership. ________________________________ Key Responsibilities
* Foster and champion a culture that promotes model-informed approaches, clearly demonstrating value to internal stakeholders and external partners, including regulators. * Plan and execute cutting-edge M&S strategies that deliver impactful insights across the portfolio. * Provide scientific and strategic input across preclinical, clinical, and post-approval development programs. * Oversee, guide, and deliver scientific and strategic modeling work for assigned projects. * Support evaluation of drug candidates for in-licensing and out-licensing opportunities. * Lead the development of drug-disease models and other quantitative methodologies to support internal and external decision-making. * Provide peer review, coaching, and mentorship for junior modeling scientists. * Contribute to the growth of the Quantitative Pharmacology function through training, knowledge sharing, and best-practice implementation. * Stay current with emerging methodologies, tools, and applications in the external scientific environment. * Enhance the organization's external profile through conference presentations and publications in recognized journals. * Ensure all modeling efforts align with current regulatory expectations and standards. * Collaborate closely with the Preclinical PK/PD team to support translational modeling efforts in discovery. ________________________________ Requirements * PhD in Pharmaceutical Sciences (with PK/PD focus), Statistics, Engineering, or another quantitative discipline. * 10-15 years of validated experience applying Quantitative Pharmacology in drug discovery and development, including experience mentoring and developing PhD-level modelers. * Demonstrated expertise in M&S, including PK, PK/PD, and statistical methodologies. * Broad translational and clinical development experience (early and late stage), with deep proficiency in Pharmacometrics. * International scientific reputation demonstrated through impactful publications in the Pharmacometrics field. * Proven track record in designing, developing, and leading portfolio-level M&S strategies, with notable disease-area experience. * Strong understanding of regulatory processes, compliance expectations, and Pharmacometrics considerations; direct regulatory interaction experience (written and/or oral) is preferred. ________________________________ For additional information, please contact: TJ Elder President Clinical Pharmacology / Pharmacometrics O: 413.458.6124 C: 413.207.7676 https://www.linkedin.com/in/tjelder/ [email protected]<mailto:[email protected]> [cid:[email protected]]<http://www.stem-sourcing.com/> Please Note: The information in this e-mail message is legally privileged and confidential information intended only for the use of the addressee(s) named above. If you, the reader of this message, are not the intended recipient, you are hereby notified that you should not further disseminate, distribute, or forward this e-mail message. If you have received this e-mail in error, please notify the sender as soon as possible. In addition, please delete the erroneously received message from any device/media where the message is stored.
