Director/Senior Director, Safety-PV Operations Lead
- Role
- Operations
- Experience
- Lead
- Employment
- Full-time
Open to Anywhere in EU. Set where you work from to check your eligibility.
No BS summary
Senior safety/pharmacovigilance leader (Director/Senior Director) to own PV operations and manage safety vendors and CROs. Must have deep knowledge of global safety requirements and experience in both small and large biotech. EU-based, full-time remote.
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.
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.
What you'll do
- Develop strategy and provide operational support for Prilenia's PV model
- Ensure a lean, agile, and cost-efficient organization that delivers excellence in safety operations
- Take ownership of Prilenia's safety operations
- Manage safety vendors and CROs
- Work closely with the Head Global Medical Safety
- Report to the Head of Safety
What they require
- Experience in a similar position in safety and pharmacovigilance
- In-depth knowledge of global safety requirements
- Experience working in both small and larger biotech environments
Benefits
- Flexible schedule
- Highly virtual and flexible organization (mostly remote)
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, GCP Quality Assurance Lead, to support programs in both Huntington’s Disease and ALS.