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Post : Clinical Affairs Scientist
Job Description:
Clinical Affairs Scientist to work within the exciting field of oncology Companion Diagnostics (CDx). As a Clinical Affairs Scientist, your main responsibilities will be to determine clinical strategy in conjunction with team members, write clinical protocols, analyze data and write reports to support the clinical documentation of Companion Diagnostics (CDx)in the field of tissue-based Cancer Diagnostics. This position requires strong support to regulatory applications and scientific marketing activities. The top candidate will have a strong background in biostatistics and experience working in oncology drug, biomarker or in vitro diagnostic clinical development. The candidate will work directly with pharmaceutical partners,clinical and R&D scientists, Clinical Trial Managers and regulatory affairs to assure compliance with internal and external requirements.
The successful candidate will be measured on:
• Your ability to contribute to the clinical strategy for CDx products.
• Your professional interactions and communication skills with pharmaceutical partners and regulatory bodies, such as the FDA.
• Your ability to work in a fast moving self-driven team.
• Your ability to write and interpret clinical protocols, reports and provide data analysis.
• Your ability to provide leadership and direction to the clinical affairs scientific staff.
Candidate Profile
University degree in pharmaceutical, medical or other relevant biological science, preferably, advanced degree.
• Minimum 8 years experience in clinical studies for diagnostic, medical device or pharmaceutical products, including authoring protocols and reports.
• A solid knowledge of clinical study design, biostatistics and Good Clinical Practice.
• Knowledge of oncology and/or pathology is preferred.
• Experience in working in parallel projects teams.
• High work capacity may be required at certain times in high priority projects.
• Experience from working with external international partners.
• Advanced skills in both written and spoken communication.
Additional Information:
Location: California
Requisition: 2073824
Industry Type: Pharma/ Biotech/Clinical Research
Job Category: Quality/Regulatory
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