Principal Scientist - DMPK
Site Name: USA - Massachusetts - Waltham
Posted Date: Oct 2 2019
Principal Scientist, DMPK
Do you have the passion to join a group whose mission is to improve the lives of patients bravely facing cancer? Does it excite you to be a part of a 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 GSK-TESARO:
The DMPK Principal Scientist is accountable for timely and effective DMPK support for projects in discovery/preclinical and clinical development and for marketed products support. The incumbent is expected to demonstrate competency in interpreting DMPK data, principally for biopharmaceuticals, and development and implementation of strategic plans for nonclinical development, as well as providing expertise and guidance in Research and Development DMPK to project teams and management. This individual will be highly analytical, decisive, goal-oriented, and timeline-sensitive while maintaining the highest of scientific and ethical standards. The Principal Scientist will actively participate on project/product teams, as well as collaborating with research unit teams. The incumbent will adhere to established processes, policies and quality systems for outsourcing, managing and reporting regulatory DMPK programs, studies and other activities in support of GSK portfolio projects and to provide appropriate content and submission-ready documentation for the DMPK components of regulatory submissions.
• Provide high-level advice to project/product teams and senior management, including evaluation of conclusions and potential impact of DMPK study results at all stages of discovery research and development including clinical.
• 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/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.
• PhD in a related subject with 5-10 years industry-related experience in Research and Regulatory DMPK working within the pharmaceutical industry. MS with relevant industry experience will also be considered.
• Hands-on experience in all aspects of DMPK study conduct for both biotherapeutics 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/CTA, 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.
• Experience within a team environment as both a member and a scientific lead with strong organizational and interpersonal skills, including exceptional oral and written communication skills with a demonstrated ability to write protocols, nonclinical/clinical study reports and scientific peer-reviewed publications.
• Ability to effectively engage with a wide variety of internal/external technical and business experts.
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