Vice President, Clinical Science & Clinical Development

About the role

Celldex is looking for a Vice President, Clinical Science & Clinical Development to serve as a senior medical and scientific leader within its Clinical organization and a key partner to the Chief Medical Officer. The role provides strategic leadership across clinical development programs, from proof of concept through late-stage development to regulatory approval and post-marketing, and builds and develops the Clinical Development organization.

Key responsibilities

• Lead clinical development strategy and execution from early development through Phase 4, with emphasis on late-stage (Phase 2-4)
• Oversee integrated clinical development plans, trial design, protocol development, and medical oversight of studies, including patient safety and eligibility
• Interpret clinical trial data, oversee clinical study reports, and take part in publication planning
• Partner with Regulatory Affairs on clinical regulatory strategy and on regulatory submissions (INDs, BLAs, NDAs, briefing documents, annual reports) and with FDA, EMA and other health authorities
• Represent Celldex at scientific congresses, advisory boards and investigator meetings, and evaluate external clinical research proposals
• Mentor clinical development physicians and scientists and build the capabilities of the Clinical Development organization

Required profile

• MD required
• Board certification or advanced clinical training in allergy, immunology, dermatology preferred, but another relevant specialty considered
• At least 10 years of clinical development experience in biotechnology or pharma, with significant leadership responsibility
• Required: experience leading clinical development of a commercial-stage product through Phase 3, regulatory submission, approval, commercialization and Phase 4
• Required: significant Phase 2 and Phase 3 experience; experience across early through post-approval development strongly preferred
• Preferred: experience with biologics and treatments for immunologic, inflammatory, allergic or mast cell-driven diseases
• Preferred: experience leading physicians, clinical scientists and multidisciplinary teams, and in both large pharma and biotech settings

Required skills

• Strong understanding of clinical trial design, execution, data interpretation, medical monitoring and benefit-risk assessment
• Ability to interpret clinical data and make sound decisions with incomplete data
• Ability to lead through influence across matrixed, cross-functional teams
• Travel up to 25%

What we offer

• Expected base salary of $401,269 to $493,561
• Annual discretionary bonus and long-term incentive
• 401(k) with employer contribution, health care and other insurance benefits for employee and family
• Paid holidays, vacation and sick days