Principal Scientist Bioanalyst
Site Name: USA - Massachusetts - Waltham
Posted Date: Feb 5 2020
Principal Scientist, Bioanalytical Scientist (Biopharmaceuticals)
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 Bioanalytical Principal Scientist is accountable for timely and effective bioanalytical support for projects in preclinical and clinical development and for marketed products support. The incumbent will be responsible for the establishment of bioanalytical assays principally for biopharmaceuticals from early research programs right through to clinical trials. They are expected to demonstrate competency in setting up bioanalytical assays, interpreting bioanalytical data, development and implementation of strategic plans for nonclinical and clinical development, as well as providing scientific expertise and guidance 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 programs, studies and other activities in support of GSK portfolio projects and to provide appropriate content and submission-ready documentation for the bioanalytical components of regulatory submissions. The bioanalytical scientists work closely with other functions within the nonclinical development area (toxicology, DMPK) as well as the clinical pharmacology, translational R&D and pharmaceutical development groups to support candidate molecules.
- To be part of a team that is responsible for interfacing with key customer groups to deliver bioanalytical assays for early research programs right through to clinical trials.
- Provide high-level advice to project/product teams and senior management, including evaluation of conclusions and potential impact of bioanalytical study results on projects and clinical/regulatory strategy.
- Participate as a functional representative in research and development project teams providing bioanalytical input and helping to define objectives and development strategies. In particular to define nonclinical and clinical assay specifications and ensure implementation in support of project goals.
- Enable and manage a CRO provider vendor network to develop and deliver relevant bioanalytical assays for pharmacokinetics, immunogenicity and biomarker assessments to support nonclinical and clinical biopharmaceuticals programs. Coordinate all activities (selection, CDAs, service agreements, contract negotiation, protocols, study reports) with selected CROs.
- Contribute to the appropriate sections of regulatory submissions and other documents (e.g. nonclinical reports, clinical protocols, INDs, CTAs, NDAs, MAAs), participate in the advisory board meetings and provide well delivered and accurate oral and/or written data presentations to the regulatory agencies. Ensure relevant GxP compliance.
- Monitor and interpret bioanalytical studies and communicate critical and significant study results. Lead discussions and decisions related to bioanalytical assessment for each candidate and define the appropriate messaging associated with written documentation of such assessments.
- PhD in a relevant subject with 5-10 years industry-related experience in Research and Regulatory working within the pharmaceutical industry that includes a deep technical and regulatory understanding of bioanalytical testing in support of research and development focusing on biopharmaceuticals bioanalysis, immunogenicity and biomarker assessment. MS with relevant industry experience will also be considered.
- Proven ability to creatively seek resolutions to scientific issues that arise during development of new biopharmaceuticals therapeutics especially within a cross-functional team environment.
- Hands-on experience in all aspects of bioanalytical study conduct including study set up, sample receiving, assay validations, sample analysis and data reporting.
- 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 and clinical 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 and clinical bioanalytical 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.
- Self-motivated, assertive, and self-confident with the ability to act with urgency and passion.
- Ability to work independently, analyze and work with attention to detail, process and prioritize sensitive complex information and problem solve.
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