Clinical Affairs Scientist

We are searching for an experienced Clinical Affairs Scientist (CAS) to work within the medical diagnostic field as a key member of the Organization of Chief Medical Officer (OCMO) Global Clinical Affairs team. The CAS' main responsibilities will be to support clinical evidence generation, in conjunction with cross-functional teams as part of the co-development process of companion diagnostics in the field of oncology. This position will support clinical trial study designs and execution, regulatory applications, and scientific marketing deliverables. The ideal candidate will have a strong background in clinical science/research and experience working in pharmaceutical, biomarker, and/or in vitro diagnostic clinical development. The candidate will work directly with pharmaceutical partners, R&D scientists, Clinical Trial Managers/ Clinical Research Associates, Quality Assurance, and Regulatory Affairs to assure compliance with internal and external requirements. This position reports to the Manager of Clinical Affairs Sciences and has no direct reports.

Responsibilities include but are not limited to:

• Provide thought leadership on key relevant clinical topics to support strategy development and execution.

• Generation of content to support external validation studies including study design and authoring of study protocols and reports. May also contribute to cutoff/cutpoint determination studies, method comparison, bridging, and analytical concordance studies.

• Design and develop databases, Electronic Data Capture (EDC) systems, and case report forms.

• Contribute to risk analyses, study quality control activities, and instream data monitoring in clinical trials.

• Ensure scientific validity of reported results including statistical analysis, tabulation, and presentation of data.

• Collaborate with regulatory and development teams during the submission process including authoring of clinical performance information and other documentation such as Instructions for Use (IFU).

• Provide clinical and scientific oversight of local marketing and commercial materials.

• Ensure effective, efficient and compliant Clinical Affairs processes including preparing, revising, and maintaining standard operating procedures for the conduct of clinical studies.

• Serve as the clinical science subject matter expert in cross-functional internal meetings as well as meetings with pharmaceutical partners and regulatory bodies.

• Author manuscripts, abstracts, whitepapers and prepare oral/poster presentations.

• Support audits and inspections as a clinical subject matter expert.

• Master's degree or advanced degree (e.g., Ph.D., Pharm. D., M.D.) in pharmaceutical, medical or relevant biomedical science fields. Advanced Degree preferred.

• 4+ years of experience in clinical research, medical writing, clinical science in the medical device and/or pharmaceutical industry.

• Familiarity with clinical trial design, conduct, and oversight including biostatistics, and Good Clinical Practice.

• Ability to interpret regulatory standards, guidance, and laws.

• Strong scientific, medical writing, and presentation skills

• Exceptional ability to manage multiple projects in a fast-paced environment with changing priorities.

• Must be able to work and make independent decisions, understand complex scientific and clinical data information, and be able to take the initiative to lead projects and assignments.

• Experience working with external partners and/or regulatory bodies including the FDA.

• Knowledge in oncology and/or pathology preferred.

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