Associate Director/Director, Clinical Scientist
Our client is a biotechnology company. They have asked us to assist them in a search for an Associate Director/Director, Clinical Scientist.
Major tasks and responsibilities include:
We seek candidates with the following qualifications:
- Plays a major role in shaping and driving the clinical development process.
- Provides regulatory and clinical program strategy, design, execution, and protocol development.
- Contributes to the design of clinical studies in close collaboration with the Medical Director and the clinical development team.
- Develops presentations and communicates study data results to colleagues internally and to external audiences.
- Authors/reviews clinical study documents in compliance with regulatory standards.
- Provides clinical input on CRF design, statistical analysis plan and drug supply planning.
- Performs and coordinates clinical data review and analysis of study results.
- Reviews and tracks efficacy and safety data and taking actions as appropriate.
- Prepares clinical content of regulatory submissions and documents.
- Performs and documents regular review of individual subject safety data.
- Prepares abstracts, posters, presentations, and publications.
- In collaboration with other clinical functions, assists in arranging investigator meetings, scientific advisory boards, Data Monitoring Committees, and steering committees.
- A Master’s degree is required.
- Must have at least five years of pharmaceutical/biotechnology experience in clinical research.
- Requires a comprehensive understanding of all stages of drug development.
- Must have clinical development experience within oncology.
- The ability to contribute to the clinical strategy and create clinical development plans is required.
- Must have a thorough understanding of FDA, GCP, ICH, and eCTD compliance standards, and relevant regulatory requirements.
- Experience interpreting clinical data and generation of supporting regulatory submissions of clinical study documents is required.
- The demonstrated ability to review and summarize study data, including experience in preparing and presenting data is required.
- Must have demonstrated strong analytical and strategic thinking skills.
- Must have demonstrated strong interpersonal communication (written and oral) skills and the ability to collaborate across disciplines.
If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.
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