Celldex Therapeutics
Clinic Director
$180,000-220,000 / year
New Haven, Connecticut
Other
On-site
2 months ago
JobLeap AI Summary
Lead clinical quality assurance and drive compliance as part of Celldex’s medical and regulatory teams, ensuring excellence across clinical studies. This high-impact Director role offers a chance to shape quality practices and mentor others in a dynamic biotechnology environment.
Leadership in clinical QA
Hands-on regulatory compliance
Focus on continuous improvement
Collaborative team environment
Major impact on trial quality
Mentorship and development
Diversity and inclusion focus
About the job
Celldex is focused on developing innovative antibody-based treatments to enhance patient lives, particularly in allergic, inflammatory, and autoimmune disorders. In this leadership role, you'll guide quality assurance within clinical studies, ensuring rigorous compliance with GCP (Good Clinical Practice) standards, and collaborate closely with internal and external stakeholders to foster a strong culture of quality.
Key Responsibilities
- Oversee the Clinical Quality Management System throughout all clinical trial processes
- Lead GCP inspection readiness for FDA and international assessments
- Manage quality events, process deviations, and CAPAs within studies
- Mentor, consult, and train on GCP compliance across project teams
- Proactively identify and address trends or risks by analyzing quality data
- Maintain, update, and communicate expertise on evolving GCP regulations
- Ensure accurate and complete documentation during study review, including SOPs and submission documents
Qualifications
- Bachelor’s degree or higher in a relevant scientific or healthcare field (preferred)
- 7–10 years of GCP quality management and clinical trial oversight
- Detailed knowledge of FDA, EU, and ICH guidelines
- Proven experience managing audits and regulatory inspections
- Strong leadership, organization, and strategic planning skills
- Adaptability and effective communication in fast-paced, collaborative environments
Benefits & Culture
- Commitment to diversity, equity, and inclusion
- Development opportunities and community outreach involvement
- Supportive and collaborative work culture
Location
- Based in New Haven, Connecticut, United States
About Celldex Therapeutics
Healthcare · 100-250
Celldex Therapeutics is a biopharmaceutical company dedicated to developing therapeutic antibodies for patients with severe inflammatory, allergic, autoimmune, and other diseases. Their pipeline includes monoclonal and bispecific antibodies designed to address mast cell-mediated diseases where existing treatments are inadequate. The company's lead program, barzolvolimab, is a humanized monoclonal antibody targeting the KIT receptor tyrosine kinase, essential for mast cell function and survival. Celldex is headquartered in Hampton, New Jersey, with additional locations in New Haven, Connecticut; Fall River, Massachusetts; and Needham, Massachusetts.
