Senior Clinical Scientist II/III (Hampton, NJ)
The Senior Clinical Scientist II/III will support Celldex’s clinical development programs by contributing to the design, data collection, and reporting of clinical studies in a manner consistent with industry standards, applicable regulations and clinical development strategy.
Individual responsibilities include:
Working with the medical director, contribute to the development of clinical protocols/amendments by performing literature review/analysis and soliciting input from medical, statistical and operational resources.
Ensure clinical data collection proceeds in a manner consistent with strategic objectives and regulatory requirements for reporting (i.e., collaborate with statisticians to produce statistical analysis plans and data displays; provide input to CRF design and data management processes; perform periodic review of clinical data).
Participate in planning for interim data analyses and reviews, including Data Safety Monitoring Board (DSMB) meetings.
Working with the medical director, monitor and evaluate emerging clinical data.
Review/interpret data to produce strategically relevant abstracts, presentations and manuscripts.
Author (and/or work with medical writer to develop) clinical documents including but not limited to: clinical protocols, briefing documents, IND annual reports, Investigator's Brochures, clinical protocols and amendments, clinical study reports, scientific manuscripts and abstracts.
Ability to develop collaborative working relationships with physicians, expert consultants, and contracted vendors.
Strong analytical mind, excellent written/verbal communication skills, attention to detail, organizational skills, and ability to work independently and as part of a team.
Strong document management skills, including proficiency with MS Word, EndNote, and Excel.
5-10 years of experience in clinical research setting, including medical writing responsibilities and oversight of (or close collaboration with) data management/analysis/reporting functions.
BA/BS degree or equivalent in a scientific or health care field required.
Minimum of 2 years in oncology; experience in immunology considered a plus.