Director, Clinical Science

Celldex Therapeutics•Hampton, NJ

6d•$176,659 - $229,427

About The Position

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. The role translates scientific and medical insights into robust clinical studies and development strategies, and leads interpretation of clinical data to inform program decisions. Working with Clinical Science physicians and cross-functional partners, the Director provides leadership across all phases of development, with particular emphasis on protocol development and study design, data review and interpretation, and data-driven decision-making. The role also serves as the Clinical Science lead for assigned studies and programs, supports scientific oversight and regulatory contributions, and mentors Clinical Scientists.

Requirements

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.
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 thinking, strong scientific judgment, and analytical skills.
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.

Nice To Haves

Advanced degree in a scientific, healthcare, or related discipline, such as PhD, PharmD, MD, DO, MS, MPH, NP, PA, or equivalent.
Experience in immunology, autoimmune diseases, inflammatory disorders, or related therapeutic areas.
Biotechnology industry experience.

Responsibilities

Lead the design and development of clinical study protocols, 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, procedures, visit schedules, 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 asset development decisions.
Integrate translational, biomarker, PK/PD, and patient-centered endpoints into clinical development programs.
Evaluate emerging scientific, competitive, clinical, and regulatory information to inform development strategies.
Lead ongoing review and interpretation of efficacy, safety, biomarker, PK/PD, immunogenicity, and patient-reported outcome data.
Develop and implement data review strategies with Biostatistics and Data Management.
Identify clinical trends, 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 development decisions throughout the product lifecycle.
Serve as the Clinical Science lead for assigned studies and development programs.
Provide scientific oversight during study conduct to support high-quality execution and data integrity.
Collaborate with Clinical Operations on 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.
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 on high-quality, compliant clinical documentation.
Contribute to scientific publications, abstracts, posters, presentations, and congress materials.
Partner with Clinical Science physicians and teams across 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 cross-functional alignment to support efficient decision-making and program execution.
Mentor and develop Clinical Scientists and contribute to a culture of scientific excellence and continuous improvement.