Prilenia

Executive Director, Clinical Operations

Prilenia

full-time

Posted on:

Location Type: Remote

Location: Remote • Massachusetts • 🇺🇸 United States

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Job Level

Lead

Tech Stack

Google Cloud Platform

About the role

  • 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 standards.
  • Lead 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.

Requirements

  • 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.
Benefits
  • Flexible schedule with interactions across North America, Europe and Israel time zones.
  • Equal opportunity employer with a focus on a diverse, inclusive, and welcoming workplace.

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
clinical operations managementproject managementpatient recruitment strategiesrisk identificationdata analysisglobal phase 3 studiesGCPFDA guidelinesICHSOPs
Soft skills
strategic thinkingleadershipstakeholder managementcommunicationproblem resolutionsituational awarenesscollaborationaccountabilityinfluencingadaptability