Build the Safety Framework for Transformational Therapies
We are partnering with a science-driven cell and gene therapy company advancing innovative therapies for patients with serious, life-threatening diseases. The organization is entering a critical phase of growth, with late-stage and/or commercial programs and an expanding global footprint. Its portfolio includes highly differentiated autologous and/or allogeneic cell therapies and gene-modified products, requiring rigorous, forward-looking safety oversight.
As the complexity and scale of the portfolio increase, the company is seeking a Director of Pharmacovigilance to provide strategic and operational leadership across global safety strategy, governance, and execution.
This is a high-impact role for a PV leader who understands the unique safety profile, long-term risk considerations, and regulatory expectations associated with advanced therapies—and who is motivated by the opportunity to build fit-for-purpose systems rather than inherit legacy structures.
The Opportunity
As Director of Pharmacovigilance, you will be responsible for designing, leading, and continuously evolving the company’s global pharmacovigilance and safety surveillance strategy across development and commercialization. You will partner closely with Clinical Development, Regulatory Affairs, Quality, Medical Affairs, and external vendors to ensure patient safety while enabling scientific progress.
This role offers meaningful ownership, visibility with senior leadership, and the opportunity to shape how safety is integrated into a rapidly maturing cell and gene therapy organization.
About the Organization & Portfolio (Confidential Overview)
- Focused on cell and/or gene therapies addressing high-unmet-need diseases
- Pipeline includes late-stage clinical and/or commercial programs, with additional assets progressing through development
- Therapies require:
- Long-term follow-up (LTFU) and post-treatment surveillance
- Complex risk management and benefit–risk evaluation
- Close alignment with global health authorities
- Organization operates with a lean, highly collaborative model, emphasizing scientific rigor, patient safety, and regulatory credibility
Key Responsibilities
Global Pharmacovigilance Strategy
- Lead the design and execution of the global pharmacovigilance strategy across clinical and post-marketing programs
- Ensure PV systems and processes are aligned with the unique requirements of cell and gene therapies, including delayed adverse events and long-term risks
- Serve as the safety subject-matter expert for asset teams, providing clear, balanced risk assessment and guidance
Safety Operations & Compliance
- Oversee safety case processing, signal detection, benefit–risk evaluation, and aggregate reporting (DSURs, PSURs/PBRERs)
- Ensure compliance with global PV regulations (FDA, EMA, MHRA, PMDA, etc.)
- Partner with Quality to support inspections, audits, and continuous improvement initiatives
Risk Management & Long-Term Follow-Up
- Lead development and maintenance of Risk Management Plans (RMPs) and REMS where applicable
- Oversee long-term follow-up (LTFU) safety strategies required for gene-modified and cell-based therapies
- Ensure safety considerations are embedded early in development and evolve appropriately post-approval
Cross-Functional Leadership
- Collaborate closely with Clinical Development, Regulatory Affairs, Medical Affairs, and Clinical Operations to ensure consistent safety messaging and decision-making
- Support regulatory interactions related to safety, including briefing documents and responses
- Provide input into protocol design, informed consent language, and investigator materials
Vendor & Team Leadership
- Manage and oversee PV vendors and external partners, ensuring high-quality delivery and compliance
- Build, mentor, and develop internal safety capabilities as the organization grows
- Contribute to the long-term evolution of the PV function and operating model
Who You Are
You are a pharmacovigilance leader with deep experience in advanced therapies and a strong understanding of how safety strategy must evolve across the product lifecycle. You are comfortable operating in environments where science is cutting-edge, resources are focused, and decisions carry meaningful impact.
Qualifications
- Advanced scientific degree preferred (MD, PharmD, PhD, or equivalent)
- 10+ years of pharmacovigilance or drug safety experience within biotech or pharma
- Direct experience supporting cell therapy and/or gene therapy programsstrongly preferred
- Strong knowledge of global PV regulations and inspection readiness
- Experience with long-term follow-up and complex risk management frameworks
- Proven ability to lead cross-functionally and operate with both strategic and hands-on orientation
Why This Role Is Compelling
- Opportunity to build and shape pharmacovigilance strategy in a cell & gene therapy organization
- High visibility role with influence across development and commercialization
- Exposure to regulators and complex global safety considerations
- Collaborative, science-first culture without heavy legacy bureaucracy
- Competitive compensation, equity participation, and long-term growth opportunity
Working Model & Confidentiality
This role needs the incumbent to be based out of New Jersey (on-site). All discussions and applications will be handled with the highest level of confidentiality.