Director/Senior Director, Clinical Science

Clinical Development Leader

This role will help lead 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 clinical sciences leadership 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

• 7-10 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 working in immunology, inflammation, dermatology or allergy indications.
• 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.

Compensation

The expected base salary range for this position is $176,659 to $263,841.

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.