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Clinical Operations Lead Jobs (NOW HIRING)

As the Director and Lead of Clinical Operations, you will oversee the design, execution, and management of clinical trials, ensuring alignment with corporate objectives and regulatory requirements.

Director of Clinical Operations

Lincoln, NE ยท On-site

$140 - $190/hr

Overview Director of Clinical Operations - Lead the Future of Senior Care Relocation assistance is available! At Diversicare, we believe in improving every life we touch by providing exceptional ...

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Clinical Operations Lead information

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$36K

$81.2K

$156K

How much do clinical operations lead jobs pay per year?

As of Aug 16, 2026, the average yearly pay for clinical operations lead in the United States is $81,196.00, according to ZipRecruiter salary data. Most workers in this role earn between $60,000.00 and $90,000.00 per year, depending on experience, location, and employer.

What is a clinical operations lead?

Clinical Operations Leads are professionals responsible for overseeing the planning, execution, and management of clinical trials within the pharmaceutical, biotechnology, or medical device industries. They ensure that studies are conducted in compliance with regulatory requirements, protocols, and timelines. Their duties often include coordinating cross-functional teams, managing budgets, and addressing operational challenges to ensure the successful delivery of clinical programs. Clinical Operations Leads play a critical role in bringing new therapies to market by ensuring that clinical studies run smoothly and efficiently.

What are the key skills and qualifications needed to thrive as a clinical operations lead?

To thrive as a Clinical Operations Lead, you need expertise in clinical trial management, regulatory compliance, and a background in life sciences or a related field, often supported by a relevant degree. Familiarity with clinical trial management systems (CTMS), Good Clinical Practice (GCP) guidelines, and certifications such as ACRP or SOCRA are typically valued. Strong leadership, organizational skills, and effective communication are crucial soft skills for guiding teams and collaborating with stakeholders. These abilities are vital to ensure efficient, high-quality clinical operations and successful trial outcomes.

How does a clinical operations lead typically collaborate with cross-functional teams during a clinical trial?

A Clinical Operations Lead serves as a central coordinator, working closely with teams such as data management, regulatory affairs, clinical research associates, and project managers. This collaboration ensures that study timelines, compliance requirements, and quality standards are met. Regular meetings and clear communication are essential, as the Lead must align diverse teams on trial objectives, resolve operational challenges, and keep the project moving efficiently. Building strong relationships across departments is key to a successful clinical trial.

What is the difference between Clinical Operations Lead vs Clinical Project Manager?

AspectClinical Operations LeadClinical Project Manager
CredentialsTypically requires a Bachelor's degree in life sciences, with some roles preferring a Master's or relevant certificationsSimilar credentials, often with additional project management certifications like PMP
Work EnvironmentLeads cross-functional teams in clinical trial operations, often within pharmaceutical or biotech companiesManages specific clinical trial projects, coordinating timelines, budgets, and resources
Employer & Industry UsageCommonly employed in pharmaceutical, biotech, and CROs for overseeing clinical operationsUsed across similar industries, focusing on project execution and management

The Clinical Operations Lead focuses on overseeing the broader clinical trial operations and team coordination, while the Clinical Project Manager concentrates on managing individual clinical trial projects, ensuring they meet deadlines and budgets. Both roles require similar credentials and are integral to clinical research teams, but their scope and focus differ.

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What cities are hiring for Clinical Operations Lead jobs?

Cities with the most Clinical Operations Lead job openings:

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States with the most job openings for Clinical Operations Lead jobs include:

Infographic showing various Clinical Operations Lead job openings in the United States as of August 2026, with employment types broken down into 93% Full Time, and 7% Contract. Highlights an 93% In-person, and 7% Remote job distribution, with an average salary of $81,196 per year, or $39 per hour.

Senior Director, Clinical Operations

BigHat Biosciences

San Mateo, CA โ€ข On-site

$275K - $295K/yr

Full-time

Medical, Dental, Vision, Retirement

Re-posted yesterday


Job description

Senior Director, Clinical Operations
Department: Drug Development
Employment Type: Full Time
Location: San Mateo, CA
Description
The role: We are seeking an experienced and motivated Clinical Operations Lead to join our drug development team, focusing on early-stage clinical development of biologic drugs in oncology and inflammatory diseases. As the Director and Lead of Clinical Operations, you will oversee the design, execution, and management of clinical trials, ensuring alignment with corporate objectives and regulatory requirements. You will lead a high-performing clinical operations function, develop strategies to accelerate development timelines, and establish best practices for trial execution. This is a unique opportunity to contribute at both strategic and operational levels in a fast-paced, collaborative startup environment.
Key Responsibilities
Leadership & Strategy:
  • Develop and execute clinical operational strategies to advance biologics for oncology and inflammatory diseases from early-phase trials to regulatory approval.
  • Collaborate with cross-functional teams (e.g., R&D, Regulatory, CMC, Translational Biomarkers) to align clinical strategies with overall company goals.
  • Provide insights into trial design, site selection, and patient recruitment strategies.
  • Serve as a key point of contact for internal and external stakeholders, including investigators, regulators, and partners; prepare for and support regulatory interactions and inspections.

Clinical Trial Execution:
  • Lead the planning, initiation, and management of clinical trials (Phase I-III), ensuring they are conducted on time, within budget, and in compliance with global regulatory standards (ICH-GCP, FDA, EMA) and company SOPs.
  • Oversee vendor selection and management, including CROs, labs, and other external partners; conduct and manage CRO site monitoring activities to ensure protocol adherence and data integrity.
  • Monitor trial progress, manage risks, and resolve operational challenges efficiently.
  • Oversee clinical site-side sample management, including collection, processing, storage, and shipment of biological samples in alignment with protocol requirements and chain-of-custody standards.

Translational Biomarker Support:
  • Partner closely with the Translational Biomarker team to ensure clinical operations infrastructure supports biomarker sample collection, handling, and logistics across all trial sites.
  • Coordinate with sites and CROs to ensure biomarker sampling plans are implemented correctly and that sample quality and completeness meet program requirements.

Data Management and Quality:
  • Oversee clinical data management activities, including data completeness, quality review, and timely query resolution to ensure high-quality, audit-ready datasets.
  • Implement and maintain data quality management processes in collaboration with data management and biostatistics partners.

Clinical Document Generation:
  • Manage the preparation and lifecycle of key clinical documents, including protocols, informed consent forms, investigator brochures, clinical study reports, and regulatory submissions, ensuring accuracy, timeliness, and compliance with applicable guidelines.
  • Coordinate cross-functional input and review cycles to deliver complete, high-quality documentation.

Budget and Resource Management:
  • Develop and manage clinical operations budgets, ensuring cost-effective resource allocation.
  • Optimize timelines and resources to meet critical milestones and deliverables.

Skills Knowledge and Expertise
  • Advanced degree in life sciences, pharmacy, or a related field (PhD, MD, PharmD preferred).
  • 10+ years of experience in clinical operations, with a strong track record in oncology and/or inflammatory diseases.
  • Experience leading operational aspects of early-phase clinical trials in the biotech or pharmaceutical industry.
  • Demonstrated ability to build and lead teams in a dynamic, startup environment.
  • In-depth knowledge of ICH-GCP guidelines, FDA/EMA regulations, and global clinical trial processes.
  • Proven experience in vendor management, CRO oversight, budget management, and trial risk management.
  • Experience in clinical site-side sample management and biomarker program support.
  • Familiarity with data management principles and data quality oversight in clinical trials.
  • Experience managing the generation of clinical documents across the trial lifecycle.
  • Exceptional communication, leadership, and problem-solving skills.
  • Experience in oncology, inflammatory diseases, and/or molecularly targeted therapies.

Total Rewards
The salary estimated for this position is $275,000 - $295,000 + bonus + options + benefits. Compensation will vary depending on job-related knowledge, skills, and experience. Actual compensation will be confirmed in writing at the time of the offer.
What BigHat Offers:
  • Range of health insurance plan options through Anthem and Kaiser (monthly credit if benefit waived)
  • Dental, and vision coverage through Guardian
  • Additional well-being benefits through Nayya, OneMedical, Wagmo, Rula, and more
  • 401(k) with company match
  • DTO, two weeks of company-wide shutdown, and 12 company holidays
  • Paid parental leave