Celldex is pioneering new horizons in immunology to deliver life-changing therapies. We are relentless in our pursuit of novel antibody-based treatments that engage the human immune system and directly affect critical pathways to improve the lives of patients with allergic, inflammatory and autoimmune disorders. We have built a culture where innovative and talented people thrive—focusing a significant effort on attracting and retaining passionate and motivated employees who want to play a role in helping people with serious health conditions and who see this effort as personally rewarding. In our highly entrepreneurial environment, employees are empowered and the opportunity for professional development occurs every day.

Overview

The role 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

• 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.
• 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.
• Experience authoring clinical protocols, regulatory documents (IND sections, clinical study reports, investigator brochures), as well as scientific publication and presentations.
• At least 2 years of experience in immunology & inflammation preferred
• 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, Excel, and PowerPoint.
• Strong medical writing skills: takes ownership of documents, 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 and to meet timelines under changing conditions

Compensation

The expected base salary range for this position is $133,579 to $199,501.

We are committed to compensating employees equitably based on several factors including experience, education, licensure/certifications, skill level, location of the position, and availability of similar talent in a competitive market.

Compensation for this role includes base salary, annual discretionary bonus, long term incentive, 401(K) plan with employer contribution, health care and other insurance benefits (for employee and family), paid holidays, vacation, and sick days. A summary of our benefits can be found on our careers page.

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.