Director/Senior Director, Safety-PV Operations Lead (EU)

Prilenia Therapeutics is a clinical-stage biotechnology company focused on developing novel therapeutics to slow the progression of neurodegenerative diseases and neurodevelopmental disorders. Our lead product candidate, pridopidine, holds Orphan Drug Designation in both Huntington’s disease (HD) and amyotrophic lateral sclerosis (ALS) in the U.S. and EU, as well as Fast Track designation from the FDA for the treatment of HD. We are conducting global Phase 3 clinical trials in both HD and ALS.

About the role

We are seeking an experienced safety professional to join our team as Safety-PV Operations Lead (Director/Senior Director). This role is critical in ensuring a lean, agile, and cost-efficient organization that delivers excellence in safety operations. The Safety-PV Operations Lead will take ownership of Prilenia’s safety operations, manage safety vendors and CROs, and work closely with the Head Global Medical Safety. The position will report to the Head of Safety.

Prilenia is a highly virtual and flexible organization with offices in the U.S., Israel, and The Netherlands. We encourage team members to work in ways that make them most effective, focusing on common goals and moving initiatives forward.

Responsibilities

• Provide strategic direction and manage global safety operations for Prilenia.
• Develop and maintain safety operational documents with partners (e.g., Joint Operating Guides, Safety Management Plans, Safety Data Exchange Agreements).
• Coordinate generation of core safety documents (e.g., DSUR, RSI in IBs, CCSI, RMP/REMS) in consultation with Regulatory Affairs.
• Responsible for arranging high-quality safety outputs in consultation with Biostatistics, QA, and external vendors.
• Support ongoing safety monitoring (signal management) and periodic reporting.
• Serve as principal point of contact and proactively manage Prilenia’s safety vendors, including organizing work orders, budgets, and administrative tasks.
• Ensure safety KPIs are met by vendors, compliance with SMPs is maintained, and risk mitigation measures are implemented.
• Develop and maintain safety procedures (governance model, SOPs) appropriate for product development stage and future commercialization; work with QA to ensure training is rolled out and documented.
• Work closely and seamlessly with Head Global Medical Safety and represent Safety operations at governance and decision forums.
• Partner with key internal departments (e.g., RA, PV QA, medical writing) to maintain regulatory/safety compliance and align expectations on safety requirements.
• Represent Prilenia toward development/commercialization partners regarding Safety operations.
• Participate in clinical trial teams and Expanded Access Programs (EAPs).

Requirements

• Advanced degree (PhD, PharmD, MSc) in a life-science or medical subject.
• At least 5 years of experience in a similar position in pharmacovigilance, with significant experience in both small biotech and larger pharmaceutical companies.
• Experience in late-stage development, initial commercialization, and compassionate use/expanded access.
• In-depth knowledge of global safety requirements, including GVP and CFR 11.
• Experience with safety systems, including ARGUS, VEEVA, and MedDRA.
• Experience in managing external partners and vendors.
• Experience with pre- and post-marketing safety/PV requirements.
• Experience in creating and maintaining CCSI & initial RMP/REMS.
• Experience dealing with regulators (e.g., FDA, Health Canada, EMA PRAC) on risk management plans and risk minimization activities.

Skills

• Excellent communication skills, both written and verbal.
• Hands-on approach to problem-solving with a willingness to take responsibility for document preparation.
• Ability to work independently and collaboratively in a team environment.

Schedule

This is a full-time, remote position in the EU. Occasional travel, including face-to-face meetings, may be required. The role involves a flexible schedule with interactions across North America, Europe, and Israel time zones.