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Senior Director Clinical Operations Jobs (NOW HIRING)

Director, Clinical Operations

Mission Viejo, CA ยท On-site

$165K - $185K/yr

... and direct operational and administrative functions impacting doctor services and clinical ... Essential Functions With PC Shareholder approval and senior leadership guidance, assist and manage ...

$215K - $240K/yr

Role Overview The Director, Clinical Operations will oversee the strategic and operational ... to senior leadership * Directs the selection of CROs and other vendors (IxRS, Central Lab ...

Director, Clinical Operations

Seattle, WA ยท On-site

$215 - $240/hr

Role Overview The Director, Clinical Operations will oversee the strategic and operational ... to senior leadership * Directs the selection of CROs and other vendors (IxRS, Central Lab ...

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How much do senior director clinical operations jobs pay per year?

As of Aug 15, 2026, the average yearly pay for senior director clinical operations in the United States is $145,969.00, according to ZipRecruiter salary data. Most workers in this role earn between $102,000.00 and $173,500.00 per year, depending on experience, location, and employer.

What are the primary responsibilities of a senior director clinical operations?

A Senior Director Clinical Operations typically oversees multiple clinical trial programs, ensuring they run efficiently, meet quality and compliance standards, and stay within budget. They provide leadership and direction to clinical operations teams, collaborate closely with cross-functional departments like regulatory affairs, data management, and medical affairs, and engage with external vendors or partners as needed. Regular responsibilities also include monitoring project progress, addressing operational challenges, managing timelines, and developing process improvements. This role is highly collaborative and requires the ability to make strategic decisions that impact the success of trial outcomes and organizational goals.

What is a senior director clinical operations?

A Senior Director of Clinical Operations oversees the planning, execution, and management of clinical trials to ensure compliance with regulatory guidelines and company objectives. They lead cross-functional teams, manage budgets, and develop strategies to optimize trial efficiency. This role requires strong leadership, strategic planning, and operational expertise to drive successful trial outcomes. They also collaborate with stakeholders, monitor trial progress, and implement process improvements.

What are the key skills and qualifications needed to thrive in the senior director clinical operations position?

To thrive as a Senior Director Clinical Operations, you need extensive experience in clinical research or healthcare management, a strong understanding of regulatory requirements (such as GCP and ICH), and typically hold an advanced degree in life sciences or a related field. Familiarity with clinical trial management systems (CTMS), project management software, and regulatory submission tools is essential, and a certification such as PMP or ACRP can be advantageous. Outstanding leadership, strategic thinking, and communication skills help you effectively manage teams and build relationships with stakeholders. These competencies ensure operational excellence, compliant trial execution, and the ability to lead large, complex projects to successful outcomes.

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What states have the most Senior Director Clinical Operations jobs?

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Infographic showing various Senior Director Clinical Operations job openings in the United States as of August 2026, with employment types broken down into 86% Full Time, 11% Part Time, 1% Temporary, and 2% Contract. Highlights an 94% Physical, 2% Hybrid, and 4% Remote job distribution, with an average salary of $145,969 per year, or $70.2 per hour.

Senior Director, Clinical Operations/GI (301)

Uniquity Bio

Malvern, PA โ€ข Remote

Full-time

Re-posted 13 days ago


Job description

Uniquity Bio is a clinical-stage biotechnology company committed to putting science and patients first. We exist to develop transformative new medicines for immune-mediated diseases, and we’re looking for bright-minded professionals driven by a desire to advance science and make a difference for people in need. Our lead asset, solrikitug, is a highly-potent TSLP inhibitor now in Phase 2 clinical trials for asthma, chronic obstructive pulmonary disease (COPD), and eosinophilic esophagitis (EoE) indications.

Join us in building an organization where people and science thrive together. You’ll have the opportunity to make a meaningful impact while working alongside a talented, agile team in an environment where ideas move quickly, colleagues are trusted, and quality remains a cornerstone.

Position Overview

The Senior Director, Clinical Operations/GI is responsible for providing operational leadership and execution oversight across Uniquity Bio’s gastrointestinal clinical development programs. This individual will play a critical role in the planning, implementation, management, and delivery of Phase 1–3 clinical trials, ensuring studies are executed with quality, speed, and operational excellence.

This role will partner cross-functionally with Clinical Development, Biometrics, Regulatory, Medical Writing, Clinical Supply, Quality, and external vendors to advance programs from early development through pivotal-stage readiness. The ideal candidate is a highly collaborative and solutions-oriented leader who thrives in a fast-moving biotech environment and enjoys building scalable operational processes while remaining close to execution.


Key Responsibilities


Clinical Trial Leadership & Execution

  • Develop and implement global operational strategies to ensure timely, high-quality, and cost-efficient delivery of clinical studies
  • Contribute operational insights to clinical development plans, feasibility assessments, and go/no-go decision-making
  • Lead day-to-day operational oversight of global and/or US-based GI clinical studies across multiple phases of Development
  • Develop and manage study timelines, operational plans, study budgets, and trial milestone
  • Ensure studies are conducted in accordance with protocol, ICH-GCP, SOPs, and applicable global regulatory requirements
  • Identify operational risks proactively and develop mitigation strategies to maintain study quality and delivery timelines
  • Drive study start-up, enrollment, database lock, and closeout activities


CRO & Vendor Oversight

  • Lead CRO and vendor selection, onboarding, governance, and performance management
  • Lead oversight and governance of CROs and external vendors supporting clinical studies
  • Establish clear expectations, KPIs, and accountability measures across external partners
  • Review vendor deliverables to ensure quality, consistency, and alignment with study objectives
  • Escalate delivery and quality issues appropriately and drive resolution through risk mitigation plans
  • Collaborate with Finance and leadership on forecasting, scope management, and budget tracking


Cross-Functional Collaboration

  • Partner closely with Clinical Development, Biometrics, Data Management, Regulatory Affairs, Medical Writing, and Clinical Supply to ensure seamless trial execution
  • Contribute operational expertise to protocol development, feasibility assessments, enrollment planning, and endpoint strategy
  • Participate in cross-functional study team meetings and support program-level planning discussions


Inspection Readiness & Quality

  • Support inspection readiness activities and maintain a strong quality mindset throughout study execution
  • Ensure operational documentation is inspection-ready and maintained according to internal standards
  • Partner with Clinical Quality and Pharmacovigilance teams to support issue escalation and resolution as needed


Operational Strategy & Process Improvement

  • Contribute to the evolution of Clinical Operations infrastructure, systems, and SOPs within a growing biotech Environment
  • Help establish scalable processes, templates, and best practices to support future pipeline growth
  • Mentor junior team members and contribute to a collaborative, accountable, and solutions-focused culture


Strategic Leadership

  • Collaborate with the CMO, CSO, and CDO to define and execute clinical strategies across the development lifecycle
  • Set annual goals, KPIs, and performance standards that align with organizational objectives
  • Foster a culture of collaboration, problem-solving, and continuous improvement across the operations function


Communication & Executive Representation

  • Represent the Clinical Operations function to the Uniquity Leadership Team
  • Present key program updates, clinical milestones, KPIs, risks, and mitigations clearly and credibly
  • Serve as a high-impact communicator both internally and externally through written reports and verbal presentations


Qualifications

  • Bachelor’s degree required; advanced scientific or healthcare degree preferred
  • 8+ years of biotech/pharmaceutical clinical operations experience, in the biotech, pharmaceutical, or CRO industry, including oversight of global Phase 1–3 trials
  • GI/inflammatory disease clinical trial experience strongly preferred
  • Experience managing CROs and external vendors within lean biotech environments
  • Strong understanding of ICH-GCP, FDA regulations, and clinical trial execution standards
  • 5+ years direct people management experience required
  • Demonstrated ability to manage complex studies with competing timelines and priorities
  • Aptitude to work well with peers, with the executive team, and external audiences such KOLs and regulatory bodies
  • Ability to thrive in a fast-paced, highly entrepreneurial environment, and to work effectively within a highly collaborative and matrixed environment
  • Strong operational leadership and project management capabilities
  • Excellent communication, organizational, and interpersonal skills
  • Strong attention to detail with the ability to maintain strategic perspective
  • Comfortable operating in ambiguity and helping build processes in a growing organization
  • Capacity to influence cross-functional teams and external partners effectively
  • Highly proactive, resourceful, and execution-oriented mindset
  • Able to travel domestically and internationally (up to 20% of the time)



Work Environment

At Uniquity Bio, we believe every team member has an impact on the patients we aim to serve. We are a nimble team with a rigorous approach to drug development that requires collaboration and transparency to maximize value, reduce risk, and deliver meaningful, best-in-class products. We are looking for self-starters who enjoy working in a complex, collaborative environment and are motivated to bring critical new medicines to people around the world. We are a small, fast-paced organization with a talented team of in-house employees and external consultants. Candidates must be self-motivated and able to work both independently and collaboratively to achieve success and impact in our dynamic work environment.

This is a U.S.-based position. Team members who live within commuting distance of our Malvern, PA or San Diego, CA office locations are expected to spend time in the office, and remote employees are expected to travel to an office on a regular basis. Specific details for both local and remote staff will be discussed and agreed upon on a case-by-case basis with the employee’s manager. Business travel may be required depending upon the specific needs of the position.

The above job description is not intended to be all-inclusive. Requirements of the position may change from time to time based on business needs.


Uniquity Bio is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All employment decisions are based on business needs, job requirements, and individual qualifications, without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status.