Clinical Scientist/Senior Clinical Scientist

Overview

We work within a highly entrepreneurial environment where personal effort and contributions are rewarded and where communication and teamwork occur every day. Support 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. Author clinical research documents (primary authorship and/or working with external medical writers) as well as assembly and interpretation of scientific and medical data. Evaluate clinical outcome measures, data review and support trial startup activities.

Responsibilities

• Author (and/or work with external medical writers to develop) clinical documents including but not limited to: clinical protocols/amendments, briefing documents, IND annual reports, Investigator's Brochures, clinical study reports, scientific presentations including abstracts, posters and manuscripts.

• 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, 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.

Qualifications

• BA/BS/RN degree or equivalent in a scientific or health care field required. Advanced degree (MS, MPH, PhD, or PharmD) preferred.

• 3-5 years of pharmaceutical/biotech industry clinical research experience , including medical writing responsibilities

• Medical writing experience authoring clinical protocols/amendments, regulatory documents (IND sections, clinical study reports, Investigator's Brochures), as well as scientific publication and presentations.

• Experience in inflammatory/ immunologic diseases preferable

• Strong medical writing skills: takes ownership of document, organizes timeline, works with co-authors, resolves discrepancies and edits to achieve consistency, uses precise accurate language and grammar.

• Strong analytical mind, excellent written/verbal communication skills, attention to detail, and organizational skills.

• Knowledge of and experience in clinical development.

• Ability to work independently, prioritize, and multitask to meet timelines under changing conditions.

• Ability to collaborate in a matrixed environment and work as part of a cross-functional team.

• Ability to develop collaborative working relationships with contracted vendors.

• Strong document management skills, including proficiency with MS Word, EndNote, Excel, and PowerPoint.

Celldex is proud to be an equal opportunity employer that strives to foster a culture of diversity, equity, and inclusion. We are committed to promoting a diverse environment through development, recruiting and community outreach.