CLINICAL SCIENTIST - Cambridge
The Senior Clinical Scientist will provide technical support to one or more Clinical Project Teams to ensure the successful design and implementation of Clinical Development Plans. Major areas of responsibility include clinical trial design, clinical data analysis, internal and external communication of project information and plans and contributions to regulatory submissions, publications and presentations.
- The clinical scientist will interact with external medical/scientific advisors, thought-leaders and clinical investigators in the therapeutic areas as well as with internal management and drug development staff to prepare/revise/maintain and efficiently execute the drug development plan
- Contribute to the planning and design of clinical studies
- Contribute and coordinating the writing and updating of clinical study protocols
- Review clinical study data
- Establish good working relationships with investigators
- Provide guidance and/or training for external personnel/parties involved in the pharmaceutical company's clinical studies
- Contribute to the writing and review of patient narratives and clinical study reports
- Facilitate, assist and/or participate in the preparation of clinical study manuscripts by Investigators, internal personnel, and/or contract writers
- Develop external advocates for the company's technology, products, and direction
- Provide clinical education support for internal customers
- Maintain clinical and technical expertise in the therapeutic area: review scientific journals, attend scientific and key technical meetings and partner with company medical, research and business teams
- Proactively provide feedback on emerging clinical/competitive trends
- Contribute to the writing and updating of Investigator Brochures, IND annual reports, and annual reports to regulatory agencies
- Assist in accomplishing department and corporate objectives
- Other duties as assigned
- Advanced degree (Pharm.D., Ph.D., M.D.) with 5+ years of Clinical or Pharmaceutical experience and knowledge of the drug development process preferred
- Prior management experience and/or team leadership skills
- Cardiometabolic or neurological experience is preferred
- Working knowledge of data organization and analysis
- Comprehensive and detailed knowledge of clinical trial implementation and sponsor/site interactions for clinical trials is preferred
If you or a Senior Clinical Scientist you know feel this could be an opportunity you would like to explore please send your most up to date resume to myself at Sara.Shields (at sign) Realstaffing.com to discuss this role.
Sthree US is acting as an Employment Agency in relation to this vacancy.