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Clinical Affairs Scientist

Novartis Pharmaceuticals Corporation

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Location:
Cambridge, MA
Posted Date:
7/28/2014
Position Type:
Full time
Job Code:
144806BR
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

The Clinical Affairs Scientist, Companion Diagnostics (CDx) will oversee clinical activities to support the FDA clearance and approval of companion diagnostics for the Novartis Oncology drug portfolio. 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. This position reports to the Global Head of Clinical Affairs, CDx and ideally based out of Cambridge, MA or possibly East Hanover, NJ. Functional Responsibilities: 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.
EEO Statement  The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
Minimum requirements  Advanced life sciences degree, such as PhD, PharmD, or nursing degree. As Required Minimum 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.

Requirements

Advanced life sciences degree, such as PhD, PharmD, or nursing degree. As Required Minimum 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.

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