---
title: 'Director/Senior Director, Safety-PV Operations Lead (EU) at Prilenia'
canonical: 'https://feeny.ai/job/director-senior-director-safety-pv-operations-lead-eu-prilenia-europe-c33nd34btw7p'
type: 'job'
last_seen: '2026-09-14'
---

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

- **Company:** Prilenia
- **Location:** Europe
- **Employment:** full-time
- **Work type:** remote
- **Posted:** 2026-08-18
- **Last confirmed live:** 2026-09-14
- **Apply:** https://jobs.lever.co/prilenia/66743af0-88d6-4112-8132-98d8dec77b6b

## Job description

## About Prilenia

Prilenia Therapeutics, a clinical-stage biotechnology company focused on the urgent mission of developing novel therapeutics to slow the progression of neurodegenerative diseases and neurodevelopmental disorders, is looking for a Director/Senior Director, Safety-PV Operations Lead in Europe, to support programs in both Huntington’s Disease and ALS. We are a flexible, fast-moving team that is quickly advancing a potential therapy poised to have major impact on the lives of patients and their families. 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. Prilenia is conducting global Phase 3 clinical trials in both HD and ALS. Pridopidine has the potential to be a pivotal treatment to address HD and ALS disease progression. Prilenia believes pridopidine’s novel mechanism of action as a Sigma-1 receptor agonist also gives it potential in numerous other neurodegenerative and neurodevelopmental conditions. To learn more about our story and company culture, visit us at https://Prilenia.com

## About the role

We are seeking an experienced safety professional to join our team as Safety-PV Operations Lead (Director/Senior Director). The Safety-PV Operations Lead is a key position responsible for developing strategy and providing operational support for Prilenia's PV model. This role is critical in ensuring a lean, agile, and cost-efficient organization that delivers excellence in safety operations. This position will take ownership of Prilenia’s safety operations and manage safety vendors and CROs. This position will closely work together with the Head Global Medical Safety. The ideal candidate will have experience in a similar position in safety and pharmacovigilance, in-depth knowledge of global safety requirements, and experience with working in both small and larger biotech environments. The position will report to the Head of Safety. Prilenia has offices in the U.S., Israel and The Netherlands. Prilenia is a highly virtual and flexible organization and encourages team members to work in the ways that make them most effective, with a focus on our common goals and drive to move things forward.

Roles and Responsibilities:

- Provide strategic direction and manage global safety operations for Prilenia
- Responsible for developing and maintaining safety operational documents with partners (such as Joint Operating Guides, Safety Management Plans (SMP), Safety Data Exchange Agreements)
- Coordinate generation of core safety documents (such as DSUR, RSI in IBs, CCSI, and RMP/REMS) in consultation with RA
- Responsible for arranging high quality safety outputs in consultation with Biostatistics, QA and external vendors
- Support ongoing safety monitoring (signal management) and periodic reporting
- Be principal point of contact and proactively manage Prilenia´s safety vendors. Organize work orders, budgets and required administrative tasks.
- Responsible for ensuring that safety KPIs are met by vendors and that compliance with SMPs is maintained, and that risk mitigation measures are implemented as required
- Responsible for safety procedures (governance model, SOPs), appropriate for state of product development and in preparation for future commercialization; work with QA to ensure that training is appropriately rolled out and documented
- Work closely and seamlessly with Head Global Medical Safety
- Represent Safety operations at governance and decision forums
- Partner with key internal departments such as RA, PV QA, medical writing to maintain regulatory/safety compliance. Align expectations with regards to safety requirements
- Represent Prilenia towards development/commericalisation partner in regards to Safety operations
- Participate in clinical trial teams and EAPs

Qualifications and Skills:

- 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 and initial commercialization and with compassionate use/expanded access.
- In-depth knowledge of global safety requirements incl. GVP and CFR 11
- Experience with safety systems, including ARGUS, VEEVA, MedDRA
- Experience in managing external partners and vendors
- Experience of pre- and post-marketing safety/PV requirements
- Experience in creating and maintaining CCSI & initial RMP/REMS
- Experience of dealing with regulators, such as FDA/Health Canada/EMA PRAC, on risk management plans and risk minimization activities
- Excellent communication skills, both written and verbal
- Hands-on approach to problem solving with a willingness to take on responsibility for getting documents in place
- Ability to work independently and collaboratively in a team environment

Location/Time Zones: This is a full-time, remote position in the EU. Occasional travel including face-to-face/in person meetings as required. Flexible schedule with interactions across North America, Europe and Israel time zones. Prilenia operates across the United States, Canada, Europe and Israel, is incorporated in the Netherlands and backed by leading life sciences investors. We are a highly flexible organization that is mostly remote and encourages team members to work in the ways that make them most effective, with a focus on our common goals and getting the job done. Prilenia is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. We are dedicated to fostering a diverse, inclusive, and welcoming workplace for all.

## About Prilenia

## Company Overview
- **One-liner**: Prilenia is a clinical-stage biopharmaceutical company developing novel treatments for neurodegenerative and neurodevelopmental disorders, with a lead candidate targeting Huntington’s disease and ALS.
- **Entity Type**: Private (clinical stage, backed by Series A and B funding)
- **Headquarters**: Boston, Massachusetts, United States (with additional offices in Naarden, Netherlands and Herzliya, Israel)
- **Founded**: 2018
- **Founders**: Dr. Michael Hayden, MBChB, PhD (CEO and founder of five prior biotech companies)

## Core Business
- **Primary industry/industries**: Biotechnology / Therapeutics for neurodegenerative diseases
- **Target customers**: B2B – healthcare providers, clinical trial sites, regulatory agencies, and ultimately patients with Huntington’s disease (HD) and amyotrophic lateral sclerosis (ALS)
- **Mission or purpose statement**: “To develop and provide sustainable access to transformative medicines for people affected by devastating neurodegenerative diseases.” [prilenia.com](https://prilenia.com/about-us/)

## Products & Services
- **[Pridopidine]**: A first-in-class, orally administered, potent and highly selective sigma-1 receptor (S1R) agonist designed to regulate neuroprotective mechanisms impaired in neurodegenerative diseases. It is currently being evaluated in a global Phase 3 trial (PROOF-HD) for Huntington’s disease and in the Phase 2/3 HEALEY platform trial for ALS. An additional confirmatory Phase 3 study (PRECISE-HD) began enrolling patients in August 2025. [prilenia.com](https://prilenia.com/about-us/) | [linkedin.com](https://linkedin.com/company/prilenia)

## Market Standing
- **Valuation/Market Cap**: Not publicly disclosed (private company)
- **Key Metric**: Total Funding – $115.5M across two rounds; Annual Revenue – $4.5M (estimated)
- **Notable Investors/Partners**:
  - **Lead Investors**: Forbion Capital Partners, Morningside Venture Partners
  - **Commercial Partner**: Ferrer (collaboration and license agreement for commercialization and co-development of pridopidine in Europe and select international markets, announced April 2025) [prilenia.com](https://prilenia.com/about-us/)
- **Growth Signals**:
  - Headcount grew 7% YoY (now 39 employees) [linkedin.com](https://linkedin.com/company/prilenia)
  - Active job postings increased 250% year-over-year, indicating scaling [linkedin.com](https://linkedin.com/company/prilenia)
  - First patient randomized in the PRECISE-HD confirmatory Phase 3 study (August 2025) [linkedin.com](https://linkedin.com/company/prilenia)

## Competitive Advantages
- **First-in-class mechanism**: Pridopidine is a highly selective S1R agonist with a differentiated mode of action aimed at restoring cellular function in neurodegenerative diseases.
- **Established safety profile**: The drug has been studied in multiple clinical trials, providing a strong safety dataset.
- **Experienced leadership**: CEO Michael Hayden previously led Global R&D at Teva and oversaw 35 drug approvals.
- **Global footprint**: Operations across the US, Canada, Europe, and Israel, with a remote-first culture that attracts top talent.

## Strategic Focus
- **Near-term priority**: Complete enrollment and generate data from the Phase 3 PROOF-HD and PRECISE-HD trials in Huntington’s disease, and continue the HEALEY platform trial in ALS.
- **Commercialization preparation**: Partner with Ferrer in Europe to prepare for potential launch, while retaining full rights in North America, Japan, and Asia Pacific.
- **Pipeline expansion**: Evaluate pridopidine in additional indications and explore new assets for neurodegenerative and neurodevelopmental disorders.

## Why Work Here
- **Mission-driven culture**: Employees are motivated by the urgent need to bring treatments to patients with devastating diseases.
- **Remote/hybrid policy**: “Working mostly remotely across Israel, Europe, and North America” – a flexible, distributed team environment. [prilenia.com](https://prilenia.com/join-us/)
- **Small, dynamic team**: With only 39 employees, individuals have high ownership and impact across functions.
- **Global collaboration**: Opportunity to work across time zones and cultures in a company backed by top-tier life sciences investors.
- **Growth trajectory**: Increasing headcount and active hiring for roles in clinical operations, quality assurance, and medical science liaisons.

## Sources
1. [prilenia.com - About Us](https://prilenia.com/about-us/)
2. [prilenia.com - Join Us](https://prilenia.com/join-us/)
3. [prilenia.com - Our People](https://prilenia.com/our-people/)
4. [linkedin.com - Prilenia Company Page](https://linkedin.com/company/prilenia)

## Other roles at Prilenia

- [Director / Senior Director, GCP Quality Assurance Lead (US/IL/EU)](https://feeny.ai/job/director-senior-director-gcp-quality-assurance-lead-us-il-eu-prilenia-boston-eakx8fwxqhvd) — Boston, MA
- [Medical Science Liaison – Neurodegeneration (United States)](https://feeny.ai/job/medical-science-liaison-neurodegeneration-united-states-prilenia-boston-wgsszzfrykr0) — Boston, MA