Clinical Operations Lead

Location: This position may be performed remotely but requires flexibility and willingness to travel as needed.

Position Summary

We’re looking for a dynamic clinical operations leader who thrives in fast-paced, high-impact environments. You’ve led complex or global clinical studies and know how to drive progress without getting bogged down in bureaucracy. You're energized by ambiguity, value accountability, and collaborate deeply across functions to deliver real results. You act with urgency because you know patients are waiting, and you’re driven by a passion for meaningful change. Whether you've learned from hard-earned lessons or helped build high-performing teams, your impact matters more than job titles. If you’re ready to do your most important work yet, we want to meet you.

This role will have shared responsibility for the strategic and tactical operational leadership across clinical programs, achieving quality and timely completion, with on target spending with established budgets. This individual will ensure successful delivery and execution of studies, including creating and managing study timelines, budgets and study management plans.

What will set you apart?

• Own outcomes. Drive studies from protocol to database lock like you’re on a mission.
• Lead without silos. Work and coordinate cross-functionally with medical, regulatory, CMC, data management, and external partners to work seamlessly and break through roadblocks.
• Challenge the default. Question timelines, vendors, processes – and propose better ways. Don’t accept “that’s how it’s always done.”
• Move at speed. If you are driven by urgency and impact, you will thrive here. We don’t track timelines – we beat them!
• Sweat the strategy. Understand the “why” behind the science and shape the “how” behind each trial.
• Own it like it’s yours. We treat this company like it’s ours – because it is. We lead with initiative, stay invested, and deliver outcomes that make a difference.

Primary Responsibilities

• Lead the study team to design, develop, execute and deliver clinical studies in accordance with clinical development plans and strategy and according to established timelines and budget.
• Serve as a Clinical Operations representative at the program level and liaise cross-functionally to support efficient and timely execution of studies within a clinical program.
• Monitor progress of clinical study activities and report on the progress of the clinical trials within an assigned program, including budget and timelines.
• Lead the evaluation, selection, and oversight of CROs and other vendors to ensure successful clinical study implementation and execution on assigned clinical program. This includes guidance on the framework for contract negotiations and vendor selection, and review and approval of vendor contracts and scope of works.
• Provides strategic and tactical guidance in risk management and anticipate/recognize risks and issues on assigned programs and associated studies; manage resolution and/or escalation of study related issues with management.
• Contribute to the writing and review of clinical documents such as protocols, informed consent forms, investigator brochures, monitoring plans, clinical study reports and DSURs on assigned program.
• Liaise with clinical site staff and investigators as appropriate to ensure optimal Sponsor-site relationships.
• May perform the Clinical Trial Manager (CTM) function on one or more trials as needed.
• Direct initiatives to identify and implement best practices and continuous improvement plans in Clinical Operations.

Qualifications and Key Success Factors

• Bachelor’s degree required; in a scientific field helpful, advanced scientific degree a plus
• 8+ years Industry experience directly managing clinical trials required. Must have worked within sponsor organization, although can be in combination with academic and CRO experience.
• In-depth knowledge of clinical study operations, ICH-GCP Guidelines and other applicable regulatory requirements.
• Demonstrated experience in study management/monitoring, as well as working, negotiating and managing performance of CROs and other external partners supporting study execution
• Experience mentoring and directing members of clinical operations teams
• Experience working with cross functional team members (e.g., Quality Assurance, Data Management, Biostats, Medical Writing, Safety, Clinical Supply Chain, Finance)
• Intellectual curiosity: ability to think critically in a fast-paced environment, with a keen sense of urgency and demonstrated creative problem solving.
• Highly organized, detail-oriented, and self-motivated and able to work autonomously, with a passion to deliver quality results
• Strong verbal and written communication skills with an ability to build relationships internally and externally

The physical and mental requirements of our roles include but are not limited to regular use of a computer, devices or other office equipment, clear communication, and occasional movement. You'll need comfort with screen work, basic hand coordination, and focus. Reasonable accommodations may be made to enable individuals with disabilities to perform these functions.

Compensation & Benefits

At Praxis, we believe that taking care of our people (and their people) is important, so we provide a world class benefits package to help you thrive. This includes 99% of the premium paid for medical, dental and vision plans. We also provide company-paid life insurance, AD&D, disability benefits, and voluntary plans to personalize your coverage. Thinking about the future? We match dollar-for-dollar up to 6% on eligible 401(k) contributions and sweeten the deal with long-term stock incentives and ESPP. We provide a discretionary quarterly bonus, an extremely flexible wellness benefit, generous PTO, paid holidays and company-wide shutdowns. Not to mention, you'll also be joining a phenomenal crew of colleagues who are smart, engaged and inspiring. We aim high, collaborate hard, and produce results. Let’s achieve the impossible together!