About Prilenia
Prilenia, a private biopharmaceutical company with a highly committed and talented global team, is seeking a Regional Clinical Trial Manager located in the US.
Prilenia has a simple but urgent mission – to bring transformative medicines to people affected by devastating neurodegenerative diseases. Unwavering in our commitment to scientific excellence, Prilenia is developing pridopidine, a unique, oral, sigma-1 receptor (S1R) agonist investigational neuroprotective therapy for ALS and Huntington’s disease (HD). Partnered with Ferrer for the commercialization and co-development of pridopidine, we plan to start two key late-stage trials to support potential approval globally in ALS and in HD in the first half of 2026.
About the role
We are seeking a dynamic Regional Clinical Trial Manager to join our team and to oversee and manage regional operational activities of global pivotal trial/s in neurodegeneration. The ideal candidate will bring deep clinical research experience with extensive experience in clinical project management and a proven track record in managing global pivotal clinical trials for biotech sponsors and support clinical operations leadership to innovate and continuously improve operational standards. Experience in rare diseases required, HD and/or ALS preferred. This is a critical individual contributor role in a growing biotech company, suitable for a candidate who is equally comfortable working independently across multiple projects and while collaborating in a matrix global team environment. The position will report to the SVP, Head of Clinical Operations.
Responsible for the oversight and management of operational activities in given regional area. Including but not limited to: multi studies regional supervision from Phase I-III, multi centers visits Ad Hoc.
Develop and oversee procedures for dealing with troubleshooting and problem solving.
Establish and monitor programs/protocols/procedures. Including but not limited to: supervision of full protocol procedures on site, joining Trainings and Visits on a routine base.
Support the evaluation of suitability of site personnel and facility for initial and ongoing conduct of clinical trial
Maintain appropriate and effective communication with vendors and other internal departments to ensure successful project completion
Build and sustain strong cross-functional relationships across diverse global teams; foster a culture of mutual accountability, collaboration, and innovation.
Communicate progress, risks, and strategic insights to executive leadership and governance committees, supporting data-driven decision-making and program advancement.
Bachelor’s degree required, preferably in science, nursing, other life sciences, biomedical discipline, or equivalent. Advanced degree preferred.
Minimum 7-10 years clinical research experience as a CRA or equivalent, such as research coordinator with of 3 years of clinical project management experience or Operations management or equivalent.
Demonstrated Clinical Monitoring and/or Data Management experience required.
Recent experience in leading the conduct of global phase 3 studies from start to completion required.
Experience with rare diseases required Experience with ALS or HD highly preferred Excellent understanding and demonstrated application of FDA guidelines, Good Clinical Practices (GCP), ICH and applicable Standard Operating Procedures.
Strong project management skills, stakeholder management and communication skills, including influencing executive leadership, cross-functional partners, and external collaborators.
Displays exceptional situational awareness in communication—adapts tone, content, and level of detail to suit the audience, from executives to technical teams. Demonstrates sound judgement in deciding what details to share or escalate.
Excellent problem-solving and decision-making skills.
Demonstrated Budget management skills required.
Ability to work independently, prioritize and work within a matrix team environment is essential. Ability to work across multiple projects with demonstrated ability to manage CROs (and other vendors) to meet or exceed KPIs tied to corporate goals and hold them accountable if they fall behind.
Proficiency with clinical research technologies and platforms (EDC, eTMF, IWRS, CTMS, etc.), plus strong skills in Microsoft Office and data analysis tools.
Willingness and ability to travel (domestic & international) and operate flexibly in virtual teams and global time zones. Travel up to 50% (regional).
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