Director, Clinical Pharmacology
Do you have the passion to join a young global biopharmaceutical whose sole mission is to improve the lives of patients bravely facing cancer? Does it excite you to be a part of a rapidly expanding company with multiple marketed products and a diverse and robust pipeline? If yes, you may be a great fit for our community of dedicated and innovative associates.
Your impact at TESARO:
As a Director, Clinical Pharmacology you will be responsible for developing and executing an oncology-specific quantitative clinical pharmacology strategy, covering both small and large molecule anti-cancer compounds from pre-IND through regulatory submission and post approval. S/he will work closely with other scientific and clinical leaders at TESARO to shape and expand the current and future portfolio in developing effective oncology agents.
• Represent the clinical pharmacology function and provide quantitative PK/PD expertise to program teams.
• Develop and execute the quantitative clinical pharmacology plan, including the modeling and simulation strategy for both small and large molecules to support data driven decision making for the dose and regimen selections.
• Collaborate with cross functional matrix teams to design and implement clinical pharmacology studies.
• Responsible for the clinical pharmacology sections of clinical and regulatory documents; interact with regulatory agencies with a focus on PK/PD matters and take a leading role in addressing clinical pharmacology queries from the agencies.
• Select and engage with quantitative clinical pharmacology CRO's to guide population PK and Exposure-Response analyses.
• Ph.D. in Pharmacokinetics, Clinical Pharmacology, Pharmaceutical Sciences or related field with 10+ years of industry experience preferred. M.D./Pharm.D./M.S. with relevant industry experience will also be considered.
• Application of clinical pharmacology practices within an oncology drug development setting essential
• Experience with both small and large molecules is preferable
• Hands-on experience with M&S tools such as NONMEM, WinNonlin, Phoenix, and R, along with a strong understanding of pharmacometrics principals is expected.
• Experience with regulatory submission is preferable.
• Thorough knowledge with FDA and ICH guidance documents including GLP regulations.
• Excellent communications skills that enable complex quantitative modeling approaches to be distilled into clinically relevant concepts.
TESARO is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.