About Prilenia
Prilenia, a private biopharmaceutical company with a highly committed and talented global team, is seeking a Vice President of Clinical Operations 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 Executive Director, Clinical Operations to join our team and lead strategic execution of global pivotal trial/s in neurodegeneration. The ideal candidate will bring extensive experience in global clinical operations, with proven track record in managing global pivotal clinical trials for biotech sponsors, and a vision to innovate and continuously improve operational standards. Experience in rare diseases required, HD and/or ALS preferred. This is a critical leadership role in a growing biotech company, suitable for a candidate who is equally comfortable driving high-level strategy and rolling up their sleeves. The position will report to the SVP, Head of Clinical Operations.
Roles and Responsibilities:
Provide strategic direction and operational leadership for pivotal global clinical programs, ensuring rigorous execution across regions and therapeutic areas to deliver studies on time, within budget, and to the highest quality standardsLead clinical operations aspects of clinical programs, including planning, coordination, delegation, communication and stepping into direct action as necessary to make sure goals are achieved on time and on budget. Provide operational insight into feasibility, timeline and cost estimates during clinical program/study development.Accountable for the successful delivery and inspection readiness of complex global pivotal trial/s; own operational timelines, budget management, enrollment performance, data quality, and risk mitigation.Lead clinical study team/s including both internal and external stakeholders, fostering accountability, collaboration and operational excellence. Develop and oversee effective and efficient clinical study plans in partnership with internal and external stakeholders. Patient Recruitment: Oversee site and investigator relationships, leading the implementation of innovative patient recruitment and retention strategies, and ensuring proactive problem-solving and stakeholder engagement across diverse populations.Quality: Ensure clinical monitoring quality and ongoing adherence to established study plans and GCP requirements. Partner with Regulatory, QA and other relevant teams to continuously improve clinical SOPs. Closely collaborate with Regulatory, Quality, Safety, Data management and clinical supply to integrate cross-functional insights into operational execution and optimize delivery of clinical supplies, data, and patient safety. 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.
Qualifications and Skills:
Bachelor’s degree or higher in Life Sciences or related field.Minimum 10 to 15 years of clinical operations management experience in biotech companies, with at least 5 years leading global phase 3 studies and cross-functional teams Recent experience in leading the conduct of global phase 3 studies from start to completion required. Experience with rare disease 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 strategic thinking and project management skills, including scenario planning, risk identification and mitigation, and ability to guide complex problem resolution at scale.Expertise in patient recruitment and retention strategies at a global scale, including innovative approaches adapted for diverse populations. Strong leadership skills and advanced 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.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.
Location/Time Zones:
• This is a full-time, remote position based in the US, eastern time zone strongly preferred.
• Expected domestic and international travel up to 30%.
• 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.
