Senior Scientist/ Principal Scientist, Translational Sciences
Posted 10 May 2018
Cambridge, MA, USA
Senior/Principal Scientist, Translational Sciences – Development Biomarkers US-MA-Cambridge
Development Biomarkers is seeking a highly motivated, experienced scientist to join a dynamic team engaged in the discovery and development of novel biomarkers for neurodegeneration. This particular role is required to develop and establish biomarker strategies in support of multiple programs in Biogen’s pipeline, with emphasis on late stage assets.
Job Category: Research & Development
Requisition Number: 34289BR
The successful candidate will have a proven track record of developing and delivering on biomarker strategies across all stages of drug development. Excellent strategic thinking, communication and collaboration skills are essential.
- Develop and implement biomarker strategies for early and late-stage assets that include large molecule, small molecule, and ASO assets
- Serve as strategic and scientific representative from Biomarkers department at Program and Clinical Development teams and integrate biomarker strategies into overall development program
- Build strong partnerships with external collaborators and vendors, as well as clinical operations, BD, regulatory, research, medical and commercial groups internally to drive effective execution of strategies
- Support the planning and execution of clinical trials; Author and review relevant sections of clinical protocols, medical affairs and regulatory documents/filings;
- Oversee biomarker assay development, validation, study sample testing and provide scientific expertise and interpretation of biomarker data to inform statistical analysis plans
- Actively engage with regulators and industry professionals via conference presentations, workshops, focus groups and publications to influence best practices for biomarker development and clinical implementation
- Bring new assay/platform capabilities in house to support biomarker analysis and provide technical expertise across platforms, with particular emphasis on LBA, qPCR, and flow cytometry technologies
- Matrix manage assay development scientists and oversee/manage multiple outsourced projects with academics, technology partners and contract research laboratories
Deep expertise in developing and executing biomarker strategies for small molecule, large molecule, nucleic acid (ASO, siRNA) and/or gene therapy modalities
- Exceptional verbal and written communication skills; proven ability able to deliver clear, concise presentations tailored to different audiences.
- Demonstrated leadership in biomarker sciences including authoring manuscripts, regulatory documents and direct interactions with regulators.
- Strong understanding of drug discovery & development, spanning all stages of preclinical and clinical development, drug approval process and life cycle management
- Ability to quickly absorb new information and develop an understanding of the relevant biology, pathway, MOA, disease indication(s) and manage multiple projects simultaneously
- Proven scientific leadership of cross-functional teams, matrix managing people and complex projects
- Demonstrated ability to influence without authority and efficiently drive alignment amongst multiple stakeholders to efficiently progress programs/projects
- Experience managing scientific collaborations and contract research labs
- Well versed in relevant technologies, particularly LBA technologies (e.g. ELISA, Gyros, Quanterix, Ella) with strong understanding of inherent advantages and limitations thereof
- Ability to prioritize and deploy resources effectively and appropriately to meet key goals and timelines
- Must be a highly flexible, results oriented, independent self-starter who enjoys working in a fast-paced dynamic environment.
- Experience in large molecule bioanalytical a plus; desire and ability to learn foundations of large molecule bioanalysis a must.
PhD with 10 years relevant experience and 5+ years’ experience directly leading biomarker strategies.