DIRECTOR/SENIOR DIRECTOR, SAFETY-PV OPERATIONS LEAD (EU)

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 Medical Science Liaison (MSL) in the United States, 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 a highly motivated and experienced Medical Science Liaison (MSL) to join our dynamic Medical Affairs team in the United States. This is a field‑based role supporting the U.S. and Canada, and reporting to the Executive Medical Director. The MSL will serve as a scientific expert in HD and ALS while building collaborative partnerships with neurologists, thought leaders and multidisciplinary care teams to support Prilenia’s clinical trials and programs. 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 US. Expected domestic/regional travel up to 70% with some international travel. Valid driver's license 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.