Director/Sr. Director Clinical Pharmacology-Precision Oncology

Director/Sr. Director Clinical Pharmacology Our Client is currently seeking a Clinical Pharmacology leader. Reporting to the SVP Early Development, the incumbent will be the clinical pharmacology representative on project teams developing small molecule modulators as precision cancer medicines. We are looking for a consummate team player seeking a collaborative environment in which to grow their career in drug development. Responsibilities In partnership with functional/project leaders, set the clinical pharmacology strategy and plans for Company's programs in clinical development. Be the functional area representative for clinical pharmacology on project teams. Lead the planning, design, conduct and analysis of standalone clinical pharmacology studies in collaboration with internal cross-functional team. Work closely with DMPK in the design and integration of clinical PK/PD activities, collaborate with Clinical Operations in the planning and conduct of clinical PK studies. Oversees activities including non-compartmental PK analysis, population PK, PK/PD, physiologically-based, and other modeling and simulation (M&S) approaches. Coordinates with internal and external team in the data review, analysis and reporting of clinical pharmacology sections of CSRs including PK and pharmacometrics analyses. Author and review clinical protocols, study reports and prepare relevant sections of regulatory documents, including INDs, clinical trial applications (CTAs), Investigator Brochures, regulatory Briefing Documents and NDAs/MAAs. Qualifications An advanced degree and years of experience in the biotech/pharmaceutical industry, with a focus in clinical pharmacology, pharmacokinetics, pharmacometrics or related discipline. Previous experience in managing clinical pharmacology programs, and in the design, execution, and regulatory reporting of clinical PK/PD studies is required. Technical depth in clinical pharmacokinetics, PK/PD analysis, and M&S approaches, preferably with experience in oncology. Experience applying M&S through development a plus. Experience conducting clinical pharmacology programs through early and late-stage development. Operational experience and familiarity with the drug discovery and development process, including external regulatory requirements. Well versed in authoring and reviewing relevant sections of regulatory dossiers. Proficient in the management of activities at contract research organizations and comfortable working in virtual outsourced model. 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/ [email protected]<mailto:[email protected]> [cid:[email 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.