Celldex · 11 hours ago
Executive Director, Clinical Sciences
Hampton, NJ
Full-time
Onsite
Lead/Staff, Director/Executive
$265K/yr - $310K/yr
5+ years expCelldex is a biotechnology company focused on innovative clinical development programs. The Executive Director of Clinical Sciences will manage a team of clinical scientists and oversee the design, data collection, and reporting of clinical studies, ensuring compliance with industry standards and regulations.
BiotechnologyHealth CareOncologyPharmaceutical
Responsibilities
Lead, develop and manage a highly functional, productive, collaborative team of clinical scientists to ensure efficiency, quality, consistency and the achievement of timely deliverables across the programs, including but not limited to:
Create and train on standardized clinical science working processes
Establish cross-functional collaboration with medical directors, clinical & development operations, medical affairs, regulatory affairs, research, corporate affairs, commercial, external physicians, expert consultants, and contracted vendors
Support medical directors in generation of strategic clinical development plans (literature/data review/advisor input)
Play a leadership role in the design of Phase 1-4 clinical studies
Own and manage the generation and drafting of protocols, protocol amendments, IBs, CSRs, clinical regulatory submissions, etc., partnering with a cross-functional team, including but not limited to research, clinical & development operations and regulatory
Leads clinical science contributions to BLA submission, including drafting content
Oversee the review, analysis, and reporting of clinical data in collaboration with medical directors to enable internal decision making and regulatory filings
Partner with cross-functional groups to map out clinical and regulatory strategies. Provide input into statistical analysis plans and data displays in accordance with regulatory and strategic objectives
Ensure data collection is consistent with/supportive of protocol and analysis plans
Contribute to data cleaning efforts by performing clinical data reviews and providing training feedback to the Clinical Operations Team; provide guidance for issues that may impact clinical trials data generation, collection, and analysis
Participate in planning for interim data analyses and reviews, including Data Monitoring Committee (DMC) meetings
In collaboration with regulatory colleagues, compile submissions including clinical data summaries/analyses, such as briefing packages
Own the development of Celldex scientific clinical presentations & publications (message development, message integration, content drafting, layout, internal and external review process, submission and speaker preparation), including but not limited to abstracts, presentations at medical/scientific meetings and manuscripts
Hire, onboard, train, manage, and develop clinical scientist team
Manage clinical scientist resourcing across programs
Assumes responsibility for individual deliverables as needed
Qualification
Required
MS/MA degree or equivalent in a scientific or health care field required
5-10 years of experience in clinical research setting, including medical writing, protocol development, and oversight of (or close collaboration with) data management/analysis/reporting functions
Extensive experience authoring clinical protocols, regulatory documents (IND sections, clinical study reports, investigator brochures), as well as scientific publication and presentations
Experience with preparation of BLA
Demonstrated experience designing and executing clinical trials in all phases of clinical development, (Phase 1-3, post-marketing)
Proven ability to design and execute clinical development plans and interpret data for decision-making and external communication
Strong knowledge of GCP and the end-to-end drug development process, including nonclinical, CMC, regulatory, pharmacovigilance, data management and clinical operations
Experience recruiting, training, mentoring, managing and leading highly functional, productive teams
Strategic thinker with an execution-focused mindset, well suited for a lean biotech environment
Ability to work in an agile, fast paced environment
Excellent written and verbal communication skills, with the ability to influence internal and external stakeholders
Excellent project management skills
Preferred
PhD's preferred
At least 4 years of experience in immunology & inflammation preferred
Benefits
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
Sick days
Company
Celldex
Celldex is pioneering new horizons in immunology to deliver life-changing therapies.
51-200 employees
H1B Sponsorship
Celldex has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2024 (1)
2022 (1)
Funding
Current Stage
Public CompanyTotal Funding
$1.54B2024-02-29Post Ipo Equity· $460.5M
2023-11-07Post Ipo Equity· $200.5M
2021-07-12Post Ipo Equity· $287.5M
Leadership Team
A
Anthony Marucci
President & CEO
Ronald A. Pepin
Senior Vice President and Chief Business Officer
Recent News
2025-11-16
Company data provided by crunchbase