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Prilenia · 3 weeks ago

Executive Director, Clinical Operations - East Coast, US

United States

Full-time

Remote

Director/Executive

10+ years exp

Prilenia is a private biopharmaceutical company focused on developing transformative medicines for neurodegenerative diseases. They are looking for an Executive Director of Clinical Operations to lead global pivotal trials, ensuring high-quality execution and operational excellence. The role requires extensive experience in clinical operations, particularly in managing global trials for biotech sponsors.

BiotechnologyHealth CareLife SciencePharmaceutical

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 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

Qualification

Clinical operations managementGlobal phase 3 studiesFDA guidelinesClinical Practices (GCP)Patient recruitment strategiesStakeholder managementClinical research technologiesProject managementSituational awarenessLeadership skillsCommunication skills

Required

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

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