Director, Pharmacometrics (Remote) Clinical Pharmacology group Job Description:
The Director of Pharmacometrics will be part of the Clinical Pharmacology group and drive quantitative clinical pharmacology strategy across all clinical and preclinical programs in oncology. The Director-PMX will be expected to drive the impact of quantitative PK/PD modeling and simulation to inform dose selection, dose optimization and dosing schedule for clinical studies as well as author regulatory documents. Summary of Key Responsibilities ∙ Enable and drive development of population PK, PK/PD, exposure-response models to support clinical programs ∙ Effectively collaborate with clinical pharmacology, Biostatistics, Data Sciences and clinical development to develop analysis plans and contributes per timelines. ∙ Manage pharmacometrics resources including consultants to meet priorities of the clinical project teams ∙ Champion model-based drug development through their work across the organization. ∙ Experience in developing quantitative strategies for impacting clinical decisions Demonstrated ability to effectively participate in an interdisciplinary team, and to oversee the work of other scientists ∙ Independently analyzes, interprets, and reports PK/PD modeling results for internal decision making and regulatory filings. ∙ Prepare responses to regulatory health authority inquiries on PK, PK/PD related issues. Qualifications ∙ Ph.D. in Pharmaceutical Sciences / Pharmacometrics or related quantitative fields or equivalent degree with ≥ 10 years of experience; OR a PharmD or equivalent degree with ≥ 12 years of experience, OR an MS or equivalent degree with ≥ 15 years of experience Expertise in pharmacometrics (e.g., population PK and PK/PD analyses, dose response and exposure-response analyses, preclinical PK/PD and dose projections for clinical studies) ∙ Experience with modeling of oncology endpoints (preclinical and clinical) is a plus; ∙ Experience with regulatory interactions (e.g., responding and resolution to regulatory queries) including filing is a plus. Superior Skills/Abilities: ∙ Passionate about science and driven by scientific curiosity ∙ Open minded, receptive to input and a strong team player ∙ Self-driven, able to multi-task and manage time-sensitive workloads ∙ Problem solver with ability to transform complex tasks into actionable deliverables ∙ Strong interpersonal skills with ability to work in matrix environment ∙ Strong written and oral communication skills Communication Skills: demonstrates ability to effectively present complex data to various audiences in both verbal and written form. Please message mw to learn more about the company, hiring manager and more. Best regards, TJ Elder TJ Elder President Pre-Clinical Development O: 413.458.6124 C: 413.207.7676 https://www.linkedin.com/in/tjelder/ tel...@stem-sourcing.com<mailto:tel...@stem-sourcing.com> [cid:image001.png@01D7D08D.042EA190]<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.
