Celldex · 6 hours ago
Director, Clinical Operations
New Haven, CT
Full-time
Onsite
Director/Executive
$177K/yr - $229K/yr
10+ years expCelldex is a company focused on clinical operations, and they are seeking a Director of Clinical Operations to provide strategic leadership to Clinical Trial Managers. The role involves overseeing clinical trial execution, vendor management, and ensuring compliance and process improvements within the clinical operations team.
BiotechnologyHealth CareOncologyPharmaceutical
Responsibilities
Lead, mentor, and develop the team of Clinical Trial Managers (CTMs), fostering a culture of accountability, collaboration, and professional growth
Provide strategic direction and operational oversight for clinical trial execution across multiple programs and indications
Ensure appropriate resource allocation, workload balance, and succession planning within the CTM team
Oversee the selection, management, and performance of clinical trial vendors, including CROs and key service providers
Establish clear vendor expectations, performance metrics, and escalation pathways
Partner with Procurement, Clinical Operations leadership, and GCP Quality representatives to optimize vendor governance processes
Drive ongoing process improvement initiatives within Clinical Operations to enhance efficiency, quality, and compliance
Ensure operational practices and systems support scalability and inspection readiness
Collaborate with GCP Quality representatives to incorporate lessons learned, audit findings, and regulatory updates into processes
Serve as a subject matter expert for GCP compliance, supporting internal training and continuous improvement
Lead inspection readiness activities across Clinical Operations, ensuring documentation, systems, and processes are maintained in an audit-ready state
Partner with GCP Quality representatives and cross-functional stakeholders to proactively identify risks and implement mitigation strategies
Provide leadership support during audits and regulatory inspections, representing Clinical Operations as needed
Qualification
Required
Bachelor's degree in life sciences or related field
10+ years of clinical research experience with increasing responsibility
5+ years in clinical trial management or clinical operations leadership
Proven experience managing and developing clinical operations teams
Strong track record of vendor management and oversight of CROs and service providers
Expertise in ICH/GCP guidelines, clinical trial regulations, and inspection readiness best practices
Excellent leadership, organizational, and communication skills
Strategic thinker with strong operational execution
Collaborative leader with ability to influence across functions and at all organizational levels
High attention to detail with strong problem-solving and risk management skills
Committed to continuous improvement, innovation, and patient-focused research
Preferred
advanced degree 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