Overview:
The Director, Clinical Science is a strategic scientific leader responsible for clinical study design, clinical data review, and execution of clinical development programs supporting innovative therapies. This individual will play a central role in translating scientific and medical insights into robust clinical studies and development strategies, while leading the interpretation of clinical data to inform key program decisions.
Working closely with Clinical Science physicians, Clinical Operations, Data Management, Biostatistics, Regulatory Affairs, Medical Writing, Biomarker/Translational Research, Pharmacovigilance, and Medical Affairs, the Director, Clinical Science will provide leadership across all phases of development, with particular emphasis on protocol development and study design, data review and interpretation, and data-driven decision making.
Responsibilities:
Clinical Study Design and Development Strategy
- Lead the design and development of clinical study protocols, protocol amendments, and associated study documents across all phases of development.
- Partner with Clinical Science physicians and cross functional stakeholders to define study objectives, endpoints, eligibility criteria, study procedures and visit schedule, safety monitoring plans, and statistical considerations.
- Ensure study designs are scientifically rigorous, operationally feasible, and aligned with regulatory and development objectives.
- Contribute to clinical development plans, indication expansion strategies, and overall asset development decisions.
- Integrate translational, biomarker, pharmacokinetic/pharmacodynamic (PK/PD), and patient-centered endpoints into clinical development programs.
- Evaluate emerging scientific, competitive, clinical, and regulatory information to inform development strategies.
Clinical Data Review and Interpretation
- Lead ongoing review and interpretation of clinical trial data, including efficacy, safety, biomarker, PK/PD, immunogenicity, and patient-reported outcomes.
- Develop and implement data review strategies in collaboration with Biostatistics and Data Management.
- Identify emerging trends, clinical signals, and development risks and provide recommendations to study teams and senior leadership.
- Lead clinical review meetings and contribute to study conclusions, integrated analyses, and clinical development recommendations.
- Present clinical data and program updates to governance committees, senior management, and cross-functional teams.
- Support benefit-risk assessments and key development decisions throughout the product lifecycle.
Clinical Trial Execution and Scientific Oversight
- Serve as the Clinical Science lead for assigned studies and development programs.
- Provide scientific oversight during study conduct to ensure high-quality execution and data integrity.
- Collaborate with Clinical Operations to support study startup, enrollment, protocol adherence, and issue resolution.
- Participate in investigator meetings, advisory boards, and interactions with key opinion leaders and external experts.
- Contribute to inspection readiness and compliance with GCP, ICH guidelines, and applicable regulatory requirements.
Regulatory and Scientific Contributions
- Author and review clinical sections of regulatory documents, including INDs, CTAs, Investigator Brochures, Clinical Study Reports, briefing packages, periodic safety reports, annual reports, and marketing applications.
- Support interactions with global health authorities and responses to regulatory inquiries.
- Collaborate with Regulatory Affairs and Medical Writing to ensure high-quality and compliant clinical documentation.
- Contribute to scientific publications, abstracts, posters, presentations, and congress materials.
Cross-Functional Leadership
- Partner closely with Clinical Science physicians, Data management, Biomarker/Translational Research, Clinical Operations, Biostatistics, Safety, Regulatory Affairs, Medical Writing, and Medical Affairs.
- Represent Clinical Science on cross-functional project teams, governance committees, and portfolio discussions.
- Drive alignment across functions to support efficient decision-making and program execution.
- Mentor and develop Clinical Scientists and contribute to building a culture of scientific excellence and continuous improvement.
Qualifications:
- Advanced degree in a scientific, healthcare, or related discipline preferred (e.g., PhD, PharmD, MD, DO, MS, MPH, NP, PA, or equivalent).
- 10+ years of clinical research, clinical development, or clinical science experience within the biotechnology, pharmaceutical, or CRO industry.
- Demonstrated experience leading clinical study design, protocol development, and clinical data review activities.
- Experience serving as Clinical Science Lead for Phase 1 through Phase 3 clinical trials.
- Proven track record of interpreting complex clinical datasets and translating findings into development strategy.
- Experience supporting regulatory submissions and health authority interactions.
- Experience in Immunology, autoimmune diseases, inflammatory disorders, or related therapeutic areas strongly preferred.
- Biotechnology industry experience preferred.
- Deep understanding of clinical trial methodology, study design, endpoint development, and statistical concepts.
- Expertise in clinical data review and interpretation of efficacy, safety, biomarker, PK/PD, and translational data.
- Strong knowledge of GCP, ICH guidelines, and global regulatory requirements.
- Excellent scientific writing, communication, and presentation skills.
- Strategic thinker with strong scientific judgment and analytical skills.
- Proven ability to influence cross-functional teams and senior stakeholders.
- Strong leadership, collaboration, and decision-making capabilities.
- Ability to thrive in a fast-paced, innovative biotechnology environment.
Compensation
The expected base salary for this position is: $176,659.00 to $229,427.00. 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 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