Reporting to the Senior Medical Director within Clinical Development in the Cambridge, MA office, the Clinical Scientist will provide scientific input to early and late stage clinical development programs.
- Contribute to the scientific development of individual clinical studies in alignment with the approved clinical development plan, including authoring and reviewing clinical documents (e.g., protocols, investigators brochure, eCRFs, ICFs, CSRs)
- Responsible for analytical support of clinical trial data (safety and efficacy), including gathering, analyzing, reviewing, interpreting, and providing preliminary assessments and recommendations
- Contribute to the clinical oversight and medical review of clinical trial data in collaboration with the Medical Monitor during the conduct of the study
- Analyze and synthesize information to assess issues relating to protocol conduct and/or individual subject safety
- Assist in communicating a clear overview of trial results
- Collaborate with internal stakeholders (clinical operations, data management, statistics, safety, commercial, and regulatory affairs) to ensure translation of the clinical protocol into operational deliverables
- Prepare literature reviews as needed
- Develop scientific and protocol training presentations to support internal and external meetings; e.g., Advisory Board meetings, investigator meetings, and training materials
- Support preparation of scientific material for conference presentations or publications
- Contribute to the authoring and revision of regulatory submissions
- Generate scientific slide decks based on clinical trials
- Contribute to multidisciplinary working groups to support continuous process improvement as requested
- Advanced degree in a scientific discipline, RN, Pharm D or PhD
- 5+ years' previous experience in clinical research
- Excellent oral and written communication skills and solid MS PowerPoint, MS Word, MS Excel, and analytical skills
- Ability to work collaboratively in a fast-paced, team-based matrix environment
- A thorough understanding of ICH, GCP, and relevant regulatory requirements, and strong analytical and strategic thinking skills, experience with interacting with medical monitors, development operations (preclinical, clinical operations, regulatory affairs, Quality Assurance) and clinical investigators
- Experience with global studies
- Experience with hematology, oncology or transplant trials, Phase I first-in-human trials, and regulatory submissions
- Collaborative – Openness. One Team.
- Undaunted – Fearless, Can-do attitude.
- Results Orientation – Delivering progress toward our mission. Sense of urgency in solving problems.
- Entrepreneurial Spirit – Proactive. Ownership mindset.
If interested and qualified, please include Requisition # 2018-365 in the subject line when emailing resume to: firstname.lastname@example.org.
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