Position Summary
Responsible for providing scientific support for Global Clinical Development activities. This includes assembling, evaluating, and presenting scientific and medical data, writing or providing content to clinical documents (clinical study protocols and protocol synopses, papers, abstracts, posters, etc.), and reviewing and summarizing relevant literature to inform strategic discussions. Working closely with colleagues in Clinical Development, the Clinical Scientist will have a substantial role in the development of the clinical documents, the review of scientific and clinical data, and the communication of data to the scientific and medical communities.

12 month plus extension!

This position reports to the head of Clinical Sciences (Executive Director Clinical Scientist) and can be hybrid at our headquarters in New Haven, CT or work remotely from a location within the U.S.

Principal Responsibilities

• Clinical Document Development
• • Contribute to the clinical portion of investigator brochures, review IB for consistency and applicability
  • Contribute in the writing and review of clinical study reports (CSRs), data safety update reports (DSURs), annual reports and regulatory briefing books
  • Manage development of internal and external presentations/publications (manuscripts, posters, etc.) of clinical study data
• Clinical Study Planning
• Study Data Review and Analysis
• Lead development of Medical Monitor Plans
• Partner with Clinical Operations, Translational Medicine, Pharmacovigilance, Data management and other functional team members at assure quality and timely study conduct and monitoring
• Support data summaries for Cohort Review Committees, Safety Review Committees, leadership, advisory board meetings, etc.
• Perform literature searches and critically review and summarize the relevant scientific, drug development and medical literature to support strategic discussions and document development, such as the investigator brochure, protocol design, clinical study report, competitive assessments, etc.

Qualifications

• Experience in oncology therapeutic area required (depending on company needs), experience in hematology/Non-Hodgkins Lymphoma preferred.
• Some basic knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations required
• Excellent project management, communication and organizational skills required with demonstrated success in leading projects and interacting with cross-functional teams
• Education: A minimum of BS/MS with 10years relevant work experience within a research and/or pharmaceutical company environment required or demonstrated in-role capabilities if less than 10 years.

Impellam Group and its brands are equal-opportunity employers committed to diversity and inclusion. All qualified applicants will receive consideration without regard to race, color, religion, gender, sexual orientation, pregnancy or maternity, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application, interview process, pre-employment activity, and the performance of crucial job functions.

If you require additional disability considerations, modifications, or adjustments please let us know by contacting HR-InfoImpellamNA@impellam.com or fill out this form to request accommodations.