This position is responsible for leading biomarker assay (fit for purpose) to companion diagnostic (CDx) development together with an outside partner for our anticancer drug candidates. This role will require a talented individual to provide technical oversight and project management for assay development, typically with external partners; the development of which spans from the initial translation of the assay from pre-clinical testing through the eventual commercialization of a CDx. This position is a cross-functional role requiring teamwork across the organization to ensure the ideal assay is selected to meet scientific, clinical, regulatory, and commercial needs. To fulfill these responsibilities, the Senior Manager will oversee the execution of biomarker assay projects through close collaboration with clinical diagnostics laboratories and CDx partners. Strong understanding of the regulatory requirements for in vitro diagnostics development and testing will be critical to guaranteeing that assays are properly developed, validated, implemented in the clinical setting, and prepared for commercialization. The Senior Manager will also be responsible for collaborating with clinical development, operations, and commercial teams to ensure biomarker testing is performed in accordance with protocols and conducted to meet clinical timelines and allow for commercial launch.
Reporting Relationship: Associate Director Research Scientist
- Establish fit for purpose biomarker strategies to support the advancement of the Boston Biomedical oncology pipeline
- Manage the timeline driven design, development, and validation of high-quality biomarker/CDx assays
- Closely collaborate with CDx partners to ensure development and regulatory approval of assays and commercial launch
- Oversee the implementation of biomarker analysis at external clinical diagnostics laboratories; review and author clinical documents needed to ensure efficient collection of samples, handling
andshipment, testing and reporting of results.
- Represent the biomarker group on cross-functional clinical project teams
- Collaborate with clinical and regulatory leads to author sections of regulatory filings including Pre-Sub, IDEs, risk assessments, and PMAs.
- Maintain current biomarker knowledge of scientific, regulatory, and clinical published literature in oncology and the competitive landscape
- Must have technical experience in the development of at least one assay format (flow cytometry, IHC/image analysis,
next generationsequencing) and familiarity with additional formats ( RTPCR, multiplexing, CISH, ELISA) is highly desirable
- Knowledge of the procedures involved in developing, validating, and assessing robustness of an assay on a commercial platform
- Outstanding relationship building and communication skills, including proven ability to drive projects forward with companion diagnostics companies to meet aggressive clinical timelines
- Strong analytical and creative problem-solving mindset
- Understanding of the requirements for qualification of testing laboratory (CAP/CLIA/ISO) as well as regulatory processes for the approval of assays (IVD procedures) to be used for selection of patients into clinical trials
- Experience drafting and reviewing regulatory documents (e.g. Pre-Sub, IDE, Q-Sub, PMA) as well as clinical documents (e.g. protocol, lab manual, IB).
- Ability to make or drive decisions rapidly when the situation calls for it.
- Advanced degree, ideally a Ph.D., in a scientific discipline with an understanding of fit for purpose biomarker assay development targeted for clinical use and eventual commercialization
- At least 3-5 years relevant work experience in biotech/pharma role developing assays
- Strong written and oral communication skills
Job Location: Cambridge, MA
Please send resumes to firstname.lastname@example.org