Senior Director, Clinical Science

Overview

The Senior Director, Clinical Science is a strategic scientific leader responsible for shaping clinical development strategy, overseeing clinical study design, and directing the interpretation of clinical data across one or more development programs. This individual serves as a key partner to Clinical Science leadership and is accountable for advancing innovative therapies through critical development milestones, including proof-of-concept, registrational studies, regulatory submissions, and lifecycle management.

The Senior Director will provide scientific and organizational leadership across a portfolio of programs, driving cross-functional alignment and influencing key development, regulatory, and portfolio decisions. This role requires deep expertise in clinical development, exceptional scientific judgment, and the ability to translate complex clinical data into actionable development strategies.

Responsibilities

Clinical Development and Portfolio Leadership

• Provide strategic leadership for one or more clinical development programs, ensuring alignment with corporate objectives and long-term portfolio strategy.
• Drive integrated development strategies across multiple studies and indications, including registration-enabling and lifecycle management activities.
• Serve as the Clinical Science representative to governance committees, development review boards, and senior leadership teams.
• Influence key program decisions, including indication prioritization, dose selection, endpoint development and validation, regulatory submission strategy, and benefit risk assessment.
• Partner with key functional stakeholders (e.g. Clinical Science physicians, Operations, Data Management, Regulatory Affairs, and Executive Leadership) to define and optimize development pathways.
• Evaluate scientific, clinical, competitive, and regulatory developments to identify opportunities and risks impacting development strategies.

Clinical Study Design Oversight

• Provide strategic oversight for study design across a portfolio of clinical programs.
• Guide development of innovative clinical trial designs, endpoint strategies, biomarker approaches, and patient selection methodologies.
• Ensure protocols support regulatory, scientific, and commercial objectives while maintaining operational feasibility.
• Champion incorporation of translational science, patient reported outcomes, and precision medicine approaches into development programs.
• Review and approve critical study design decisions, protocols, amendments, and key study documents developed by Clinical Science teams.
• Partner with Clinical Science physicians and cross-functional stakeholders to ensure studies address key development questions and support regulatory objectives.

Strategic Clinical Data Leadership

• Lead interpretation of integrated efficacy, safety, biomarker, PK/PD, immunogenicity, and translational datasets across studies and programs.
• Drive benefit-risk assessments and provide strategic recommendations that influence major development and portfolio decisions.
• Lead cross-functional data review activities and provide clear scientific guidance to project teams and senior leadership.
• Present clinical findings, development strategies, and recommendations to Executive Leadership, governance committees, and external stakeholders.
• Ensure clinical data are translated into actionable insights supporting regulatory strategy, asset differentiation, and future development planning.
• Identify emerging risks and opportunities and drive proactive mitigation strategies.

Regulatory and Health Authority Strategy

• Provide strategic leadership for clinical components of global regulatory submissions, including INDs, CTAs, Investigator Brochures, Clinical Study Reports, briefing packages, and marketing applications.
• Contribute to regulatory strategy and support interactions with global health authorities, including FDA, EMA, and other regulatory agencies.
• Guide clinical positioning to maximize the probability of regulatory success.
• Support preparation for regulatory meetings, inspections, and advisory committee activities.
• Contribute clinical expertise to due diligence activities, business development opportunities, and strategic partnerships.

External Scientific Leadership

• Develop and maintain relationships with key opinion leaders, investigators, academic collaborators, and scientific advisors.
• Represent the company at major scientific congresses, advisory boards, and external scientific forums.
• Shape publication strategies and oversee clinical support of abstracts, manuscripts, presentations, and scientific communications.
• Monitor advancements in Immunology and related therapeutic areas and assess implications for company programs and portfolio strategy.

Organizational and People Leadership

• Lead, mentor, and develop Directors, Associate Directors, and (Senior) Clinical Scientists.
• Build organizational capabilities and establish Clinical Science best practices that support a growing biotechnology organization.
• Contribute to workforce planning, succession planning, and talent development initiatives.
• Foster a culture of scientific excellence, accountability, innovation, and collaboration.
• Promote effective cross-functional partnership and serve as a trusted scientific advisor across the organization.

Qualifications

• Advanced degree in a scientific, healthcare, or related discipline preferred (e.g., PhD, PharmD, MD, DO, MS, MPH, NP, PA, or equivalent).
• 15+ years of clinical research, clinical development, or clinical science experience within the biotechnology, pharmaceutical, or CRO industry.
• Significant experience leading Clinical Science activities across Phase 1 through Phase 3 clinical development programs.
• Demonstrated expertise in clinical study design, protocol development, and interpretation of complex clinical datasets.
• Proven success influencing clinical development strategy and advancing programs through major development milestones, including proof-of-concept, registrational studies, and regulatory submissions.
• Experience supporting global regulatory submissions and health authority interactions.
• Demonstrated ability to present development recommendations to Executive Leadership and governance committees.
• Prior people leadership experience with responsibility for developing managers and senior scientific staff.

 

Compensation 

The expected base salary for this position is: $203,157.00 to $263,841.00. 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 pageCelldex 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.