New · posted Nov 5
Celldex Therapeutics · Biotechnology
Director, Clinical Science
- Hampton, NJ
- On-site
- Full-time
- Director
The role
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.
What you need
- 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.
What you'll do
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.
Pay and benefits
$176,659 – $229,427 a year
Employer providedAnnual discretionary bonus
Long-term incentive
401(k) with employer contribution
Health care and other insurance benefits
Paid holidays
Vacation and sick days
Where you'll work
Hampton, NJOn-siteOpen in Maps (opens in a new tab)
More jobs in Hampton, NJ
From the posting
About Celldex Therapeutics
About Celldex
Celldex is pioneering new horizons in immunology to deliver life-changing therapies. We are relentless in our pursuit of novel antibody-based treatments that engage the human immune system and directly affect critical pathways to improve the lives of patients with allergic, inflammatory and autoimmune disorders. We have built a culture where innovative and talented people thrive—focusing a significant effort on attracting and retaining passionate and motivated employees who want to play a role in helping people with serious health conditions and who see this effort as personally rewarding. In our highly entrepreneurial environment, employees are empowered and the opportunity for professional development occurs every day.
Equal opportunity, accessibility and legal noticesCelldex Therapeutics's statements, word for word
The expected base salary for this position is: $176659.00 to $229427.00. 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. Subject to eligibility and applicable plan terms, compensation 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.
Job intelligence
The context around this role
Live data · November 5, 2026
Salary intelligence
How the pay compares
This role's midpoint is 32% below the US median for Clinical Development roles at this level.
This roleEmployer provided
Director roles in New Jersey34 roles publishing pay
Director roles in the US218 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $176,659 | — | $229,427 |
| New Jersey (middle half) | $270,500 | $275,250 | $329,500 |
| All US (middle half) | $259,625 | $299,500 | $333,000 |
This role: Celldex Therapeutics's own published range. Comparisons: the base pay employers published on open Clinical Development roles at the same level on Regulatory Jobs, November 5, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Clinical Development
The general path across 280 open Clinical Development roles on Regulatory Jobs, with the titles they carry most. Not Celldex Therapeutics's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 43 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership19
- Clinical trial conduct14
- Documentation and SOPs12
- Data and digital systems4
- GMP and compliance2
- Lab testing and methods2
- Investigations and CAPA2
- Regulatory submissions2
- Quality systems and risk2
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Clinical Development work in biotechnology, led by the two this posting names, each linked to the agency or standards body that publishes it.
- ICHICH E6(R3) good clinical practice(official source, opens in a new tab)The international standard for the design, conduct and reporting of clinical trialsNamed in the posting
- FDA21 CFR Part 312(official source, opens in a new tab)Investigational New Drug applications and sponsor duties in drug trialsNamed in the posting
- FDA21 CFR Part 50(official source, opens in a new tab)Protection of human subjects: informed consent in FDA-regulated trials
- FDA21 CFR Part 56(official source, opens in a new tab)Institutional review boards for FDA-regulated clinical investigations
- ICHICH E8(R1)(official source, opens in a new tab)General considerations for clinical studies and quality by design in trials
- ICHICH E9 and E9(R1)(official source, opens in a new tab)Statistical principles for clinical trials and estimands
- ICHICH E2A to E2F(official source, opens in a new tab)Clinical safety data management, expedited reporting and periodic safety reports
- ICHICH E3(official source, opens in a new tab)Structure and content of clinical study reports
- FDAFDA Investigations Operations Manual(official source, opens in a new tab)How FDA investigators plan and conduct inspections
- EUEU Clinical Trials Regulation 536/2014(official source, opens in a new tab)How clinical trials of medicines are authorized and run in the EU, through CTIS
- HHS45 CFR Part 46 (Common Rule)(official source, opens in a new tab)The federal policy for the protection of human research subjects
- NIH42 CFR Part 11(official source, opens in a new tab)Clinical trial registration and results reporting on ClinicalTrials.gov
- FDAFDA Bioresearch Monitoring (BIMO)(official source, opens in a new tab)FDA inspections of clinical investigators, sponsors, IRBs and GLP labs
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- HHSHIPAA Privacy Rule(official source, opens in a new tab)Federal protections for individually identifiable health information
- EUGDPR (Regulation 2016/679)(official source, opens in a new tab)The EU General Data Protection Regulation for personal data, including health data
Company hiring pulse
Celldex Therapeutics on Regulatory Jobs
- 9
- Open roles
- 9
- Distinct roles
- 3
- Locations
By discipline
- Quality5 56%
- Clinical4 44%
By level
- Director4 44%
- Associate & Specialist2 22%
- VP & Executive1 11%
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Director, Clinical Science at Celldex Therapeutics
Applications close November 4. $177K–$229K a year, employer provided.