Overview

Join a growing Clinical Science team where you will work directly with the VP, Clinical Science.  You 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.  This position assembles, interprets, and presents scientific and medical data. Responsibilities will also include evaluation of clinical outcome measures, data review and trial startup activities.

Responsibilities

• Working with CMO, VP, Clinical Science and medical directors, contribute to the development of clinical protocols/amendments by performing literature review/analysis and soliciting input from medical, statistical and operational, as well as pre-clinical, 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, posters and scientific presentations.

Qualifications

• 5-10 years of experience in clinical research setting, including medical writing and oversight of (or close collaboration with) data management/analysis/reporting functions.
• MS/MA degree or equivalent in a scientific or health care field required. PhD’s preferred.
• Experience authoring clinical protocols, regulatory documents (IND sections, clinical study reports, investigator brochures), as well as scientific publication and presentations.
• Ability to collaboratively develop relationships with physicians, expert consultants, and contracted vendors.
• At least 2 years of experience in immunology & inflammation preferred.
• 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 Office Suite.
• Strong medical writing skills: takes ownership of document, organizes timeline, works with other co-authors, resolves discrepancies and edits to achieve consistency, uses precise accurate language and grammar
• Knowledge and experience in clinical development
• Ability to multitask to meet timelines under changing conditions.