Senior Director, Clinical Science

About the role

Celldex, a biotechnology company focused on antibody-based immunology therapies for allergic, inflammatory and autoimmune disorders, is hiring a Senior Director, Clinical Science in Hampton, NJ. The role is a strategic scientific leader who shapes clinical development strategy, oversees study design and directs the interpretation of clinical data across one or more development programs. It is a key partner to Clinical Science leadership and is accountable for advancing therapies through proof-of-concept, registrational studies, regulatory submissions and lifecycle management.

Key responsibilities

• Lead clinical development programs and portfolio strategy, serving as Clinical Science representative to governance committees and development review boards
• Influence decisions on indication prioritization, dose selection, endpoints, regulatory submission strategy and benefit-risk assessment
• Oversee study design, including protocols, amendments, biomarkers, patient selection and translational science approaches
• Interpret efficacy, safety, biomarker, PK/PD and immunogenicity data and lead benefit-risk assessments
• Lead clinical components of global regulatory submissions (INDs, CTAs, Investigator Brochures, Clinical Study Reports, briefing packages, marketing applications) and support interactions with the FDA, EMA and other agencies
• Build relationships with key opinion leaders, represent the company at scientific congresses and shape publication strategies
• Mentor Directors, Associate Directors and Clinical Scientists and contribute to workforce and succession planning

Required profile

• Advanced degree in a scientific, healthcare or related discipline preferred (PhD, PharmD, MD, DO, MS, MPH, NP, PA or equivalent)
• 15+ years of clinical research, clinical development or clinical science experience in biotechnology, pharmaceutical or CRO
• Significant experience leading clinical science across Phase 1 through Phase 3 programs
• Proven success advancing programs through proof-of-concept, registrational studies and regulatory submissions
• Prior people leadership experience developing managers and senior scientific staff

Required skills

• Clinical study design, protocol development and interpretation of complex clinical datasets
• Global regulatory submissions and health authority interactions
• Ability to present development recommendations to executive leadership and governance committees

What we offer

• Expected base salary of $203,157 to $263,841
• 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