The Senior Principal Scientist (equivalent to Director) of DMPK is accountable for timely and effective DMPK support for programs in preclinical and clinical development and for marketed products support. Reporting to the Senior Director of DMPK and Bioanalytical Sciences, the incumbent will bring strong competency in interpreting DMPK data, development and implementation of strategic plans for nonclinical development, as well as providing expertise and guidance in Discovery and Development DMPK to project/program teams and TESARO management. The ideal candidate will actively participate on project/program/product teams, as well as collaborate with Strategic Drug Hunting Partnership teams in the identification and review of new business initiatives and in-licensing opportunities.
• Provide high-level advice to project/program/product teams and senior management, including evaluation of conclusions and potential impact of DMPK study results on program and clinical/regulatory strategy.
• Review and approve DMPK study protocols, reports, associated nonclinical summaries, regulatory submission sections and associated documentation, as well as abstracts/manuscripts for publication.
• Design, manage, analyze, review, summarize, interpret and report results of DMPK studies including TK aspects of Toxicology and Safety Pharmacology.
• Maintain up-to-date DMPK plans for all projects/programs/products, including listings of studies, timelines, status and costs; update and refine as necessary.
• Provide scientific/technical due diligence support for Business Development activities as required.
• Prepare for and participate in regulatory agency interactions.
• Adhere to established processes, policies and quality systems for outsourcing, managing and reporting regulatory DMPK programs, studies and other activities in support of TESARO portfolio programs.
• Provide appropriate content and submission-ready documentation for the DMPK components of regulatory submissions.
• PhD in a related subject with 10+ years of industry experience in Discovery and Regulatory DMPK.
• Hands-on experience in all aspects of DMPK study conduct for both biologics and small molecules including both in vitro and in vivo assessment, metabolite elucidation and pharmacokinetics/toxicokinetics.
• In-depth knowledge and hands-on experience on PK/PD and PBPK modeling is highly preferred.
• Experience representing function to global regulatory agencies in support of submissions at all stages of development, i.e. IND/CT A, CTD, IMPD, MAA/NDA/BLA/JNDA.
• Demonstrated knowledge of global regulatory requirements and expectations for nonclinical DMPK packages to support first in human, clinical development, and product registration, including thorough knowledge of GLP, GCP, ICH and other applicable global guidelines.
• Extensive experience in the outsourcing and external oversight of nonclinical DMPK studies conducted by qualified suppliers.
• Exceptional oral and written communication skills with a demonstrated ability to write protocols, nonclinical/clinical study reports and scientific peer-reviewed publications.
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.