Clinical Affairs Scientist Job

CLINICAL AFFAIRS SCIENTIST needed for a CONTRACT opportunity with Yoh's client located in CAMBRIDGE, MA.

WHAT YOU'LL BE DOING:

- The Clinical Affairs Scientist, Companion Diagnostics (CDx) will oversee clinical activities to support the FDA clearance and approval of companion diagnostics.
- The focus of the role will include the design, conduct, and interpretation of a variety of clinical studies to demonstrate the function and utility of companion diagnostic tests.
- In addition, activities will include preparation of regulatory documents and potentially aspects of clinical laboratory site monitoring.
- The Clinical Affairs Scientist is an individual contributor role working with highly collaborative teams and external partners.
- Direct the design, conduct, and interpretation of clinical studies to support IVD companion diagnostics for regulatory submissions including:
- Bridging studies to demonstrate diagnostic utility in the context of pivotal clinical trials
- Method comparison studies of the novel companion diagnostic in comparison to gold standard approaches
- Multi-laboratory reproducibility studies of the diagnostic test kit
- Sample acquisitions studies of rare tumor types, conducted under GCP
- Manage clinical studies including detailed oversight of TMFs and laboratory data
- Support regulatory activities for companion diagnostics including briefing books, IDE preparation, risk assessment, CSRs, etc.
- Manage IVD laboratory site monitoring in the capacity of study sponsor, to ensure GxP and regulatory compliance.
- Project management of external vendors and CROs for laboratory testing and clinical studies.
- Daily engagement with multi-disciplinary CDx subteams and external partners on multiple diagnostic projects.

WHAT YOU NEED TO BRING TO THE TABLE:

- Advanced life sciences degree, such as PhD, PharmD, or nursing degree.
- Minimum three (3+) years of experience in pharmaceutical and/or diagnostic industry setting.
- Particular expertise in the areas of diagnostics, biomarkers, laboratory testing, clinical trials, and oncology.
- Prior management experience with external vendors is favorable.
- Motivated with strong interpersonal and verbal/written communication skills required, ability to bridge scientific with business communication and strong negotiation skills.

OPPORTUNITY IS CALLING, APPLY NOW!

RECRUITER: Krista Leach

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.

J2W: SCIENTIFIC

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SFSF: LS