Celldex · 1 day ago
Executive Director, Pharmacovigilance & Risk Management
Hampton, NJ
Full-time
Onsite
Director/Executive
$340K/yr - $370K/yr
8+ years expCelldex is seeking an Executive Director for Pharmacovigilance and Risk Management to provide strategic leadership and oversight of the clinical safety department. The role involves managing safety reports, interacting with regulatory authorities, and ensuring safety practices across all programs.
BiotechnologyHealth CareOncologyPharmaceutical
Responsibilities
Global management of departmental operations (resourcing, operating procedures, training, technology, budget, etc.)
Maintains currency with global regulations and guidance related to safety surveillance and reporting; serves as expert resource within the organization regarding interpretation and implementation
Ensures practices and infrastructure to support all safety surveillance activities including but not limited to individual case processing/evaluation and signal detection through aggregate safety data medical review; directly participates in these activities as needed
Leads the continuing evolution and improvement of practices to ensure timely identification, evaluation and management of safety risks throughout the product life-cycle
Utilizes scientific/clinical expertise to interpret, synthesize and communicate complex safety information; contribute to the development of benefit/risk assessments, aggregate data reports, safety-related submissions/responses to health authorities, etc
Routinely liaises with applicable functional areas (Clinical Science and Operations, Regulatory Affairs, Biostatistics, Medical Affairs) on drug safety related matters
Qualification
Required
Thorough understanding of the drug development process and safety surveillance activities, gained through significant experience (at least 8-10 years) in the clinical research industry
In-depth knowledge of global regulations and standard industry practices for management of pre and post-marketing drug safety
Proven leadership ability with experience recruiting and managing pharmacovigilance personnel
MD required
Team Player, ability to manage by influence
Excellent oral and written communication skills
Ability to work in fast-paced small company environment
Preferred
specialty and or experience managing drug safety in immunology/inflammation indications desirable
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