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Head Clinical Operations Biotech Jobs (NOW HIRING)

Tr1X

Director, Clinical Operations

San Diego, CA

About Tr1X Tr1X is a clinical-stage biotechnology company developing engineered Tr1 cell therapies ... head-on. With an unwavering commitment to patients, science and one another, we foster an ...

Tr1X

Director, Clinical Operations

San Diego, CA · On-site

About Tr1X Tr1X is a clinical-stage biotechnology company developing engineered Tr1 cell therapies ... head-on. With an unwavering commitment to patients, science and one another, we foster an ...

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Head Clinical Operations Biotech information

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$282.5K

How much do head clinical operations biotech jobs pay per year?

As of Jun 10, 2026, the average yearly pay for head clinical operations biotech 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 is the difference between Head Clinical Operations Biotech vs Clinical Operations Manager?

AspectHead Clinical Operations BiotechClinical Operations Manager
ResponsibilitiesOversees entire clinical development strategy, manages multiple teams, and aligns clinical goals with company objectives.Manages daily clinical trial activities, supervises clinical staff, and ensures trial compliance.
Required CredentialsAdvanced degree (e.g., MD, PhD, or MSc), extensive industry experience, leadership skills.Bachelor’s or Master’s degree in life sciences, relevant clinical trial experience.
Work EnvironmentStrategic, cross-functional leadership in biotech or pharma companies.Operational, site-focused environment managing clinical trial sites and teams.

The Head Clinical Operations Biotech typically holds a higher strategic role, overseeing multiple projects and teams, while the Clinical Operations Manager focuses on day-to-day trial management. Both roles require relevant clinical experience, but the head role emphasizes leadership and strategic planning within the biotech industry.

What are the key skills and qualifications needed to thrive as a Head of Clinical Operations in Biotech, and why are they important?

To thrive as a Head of Clinical Operations in Biotech, you need extensive experience in clinical trial management, regulatory compliance, and a relevant advanced degree such as an MS, PharmD, or PhD. Familiarity with clinical trial management systems (CTMS), electronic data capture (EDC), and certifications like GCP (Good Clinical Practice) are typically required. Strong leadership, strategic planning, and excellent communication skills are essential for managing cross-functional teams and external partners. These competencies are vital to ensure efficient trial execution, regulatory adherence, and the successful delivery of clinical programs.

What are some common challenges faced by a Head of Clinical Operations in a biotech company, and how can they be addressed?

One common challenge for a Head of Clinical Operations in biotech is managing the complexities of early-phase clinical trials while ensuring regulatory compliance and timelines are met. This role often requires balancing innovative scientific approaches with strict operational oversight and resource constraints. Effective communication with cross-functional teams, such as regulatory affairs, medical, and data management, is essential to anticipate and resolve issues quickly. Building a resilient team and fostering a collaborative environment can help overcome logistical hurdles and enhance trial execution efficiency.

What does a Head of Clinical Operations in biotech do?

A Head of Clinical Operations in biotech oversees the planning, execution, and management of clinical trials for new drugs or therapies. They lead teams to ensure that studies are conducted according to regulatory standards, timelines, and budgets. Their responsibilities include collaborating with cross-functional departments, managing vendor relationships, and ensuring patient safety and data integrity. This role is crucial for bringing innovative treatments from the lab to patients while maintaining compliance with industry regulations.
Infographic showing various Head Clinical Operations Biotech job openings in the United States as of June 2026, with employment types broken down into 62% As Needed, 13% Full Time, and 25% Part Time. Highlights an 95% Physical, 2% Hybrid, and 3% Remote job distribution, with an average salary of $145,969 per year, or $70.2 per hour.
Director, Clinical Operations (Lung Program)

Director, Clinical Operations (Lung Program)

4D Molecular Therapeutics

Remote

Full-time

Posted 10 days ago

Job description

Attention recruitment agencies: All agency inquiries are vetted through 4DMT's internal Talent Acquisition team. No unsolicited resumes will be accepted. The 4DMT Talent Acquisition team must expressly engage agencies on any requisition. Agencies contacting hiring managers directly will not be tolerated, and doing so may impact your ability to work with 4DMT in the future.
4DMT is a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to transform treatment paradigms and provide unprecedented benefits to patients. The Company's lead product candidate 4D-150 is designed to be a backbone therapy forming the foundation of treatment of blinding retinal vascular diseases by providing multi-year sustained delivery of anti-VEGF (aflibercept and anti-VEGF-C) with a single, safe, intravitreal injection, which substantially reduces the treatment burden associated with current bolus injections. The Company's lead indication for 4D-150 is wet age-related macular degeneration, which is currently in Phase 3 development, and second indication is diabetic macular edema. The Company's second product candidate is 4D-710, which is the first known genetic medicine to demonstrate successful delivery and expression of the CFTR transgene in the lungs of people with cystic fibrosis after aerosol delivery
GENERAL SUMMARY:
Provide strategic and operational leadership for global clinical trial execution across the 4DMT lung portfolio. This role is responsible for delivering clinical programs aligned with corporate timelines, budget, quality, and regulatory expectations while building scalable operational infrastructure appropriate for a fast-paced biotechnology environment. The Director, Clinical Operations will lead internal Clinical Operations teams and external partners/CROs and collaborate with external teams to ensure efficient, high-quality, inspection-ready execution of Phase 1-3 clinical studies.
This individual will serve as a key cross-functional leader and Clinical Operations subject matter expert, driving operational strategy, proactive risk mitigation, and execution excellence across global development programs.
MAJOR DUTIES & RESPONSIBILITIES:
  • Develop and execute global clinical operations strategies aligned with corporate objectives, program timelines, budgets, quality standards, and regulatory requirements.
  • Provide strategic operational leadership for Phase 1-3 clinical trials, ensuring efficient and compliant study execution across multiple global programs.
  • Lead sponsor-side oversight and governance of CROs and critical vendors, including vendor selection, performance management, issue escalation, quality oversight, budget accountability, and operational delivery.
  • Proactively identify, assess, and mitigate operational risks impacting timelines, enrollment, quality, budget, or regulatory compliance.
  • Drive operational scalability and process optimization while maintaining execution excellence in a lean, fast-paced biotechnology environment.
  • Develop and oversee global study timelines, resourcing strategies, and organizational planning across multiple dynamic programs.
  • Build, mentor, and lead high-performing Clinical Operations teams, including hiring, talent development, performance management, and organizational growth.
  • Partner closely with Therapeutic Area Heads (TAHs), Project Team Leaders (PTLs), Clinical Science, Regulatory Affairs, Biometrics, Quality, and other cross-functional stakeholders to ensure aligned program execution and timely decision-making.
  • Serve as Clinical Operations representative and subject matter expert on cross-functional product development teams and governance committees.
  • Provide operational leadership and support for clinical trial protocol development, feasibility assessments, country and site strategy, enrollment planning, and study startup activities.
  • Lead Clinical Operations contributions to annual budget planning, quarterly forecasting, resource planning, and financial oversight for assigned programs.
  • Ensure continuous inspection readiness across clinical programs, including oversight of TMF quality, audit preparedness, CAPA management, and health authority inspection support.
  • Partner closely with Quality Assurance to maintain compliance with GCP, FDA, EMA, PMDA, ICH, and other applicable regulatory requirements and quality standards.
  • Collaborate with Regulatory Affairs and Clinical Science to support regulatory submissions and ongoing compliance requirements, including ClinicalTrials.gov disclosures and global regulatory obligations.
  • Contribute operational expertise to business development and due diligence activities, as applicable.
  • Develop and present program updates, operational metrics, key risks, and mitigation strategies to senior leadership and executive management.
  • Support development, implementation, and continuous improvement of SOPs, operational processes, and scalable infrastructure to support organizational growth.
  • Foster a culture of accountability, collaboration, operational excellence, and clear cross-functional communication.

Core Competencies, Knowledge & Skill Requirements
  • Demonstrated leadership in sponsor-side clinical operations within biotechnology and/or pharmaceutical environments.
  • Proven ability to lead global Phase 2 and/or Phase 3 clinical trials with accountability for operational delivery.
  • Strong experience managing CROs and external vendors from the sponsor perspective.
  • Demonstrated ability to influence cross-functional stakeholders and drive decision-making in ambiguous or rapidly evolving environments.
  • Strong operational and strategic leadership skills with ability to balance high-level portfolio strategy and detailed execution oversight.
  • Ability to proactively identify operational risks and implement effective mitigation strategies.
  • Proven ability to recruit, develop, retain, and motivate high-performing Clinical Operations teams.
  • Strong financial acumen with experience managing clinical trial budgets, forecasts, and resource planning.
  • Deep understanding of FDA, EMA, PMDA, ICH-GCP guidelines, and global clinical trial regulations.
  • Experience supporting inspection readiness activities, audits, and regulatory inspections.
  • Excellent organizational skills with the ability to manage multiple complex global programs simultaneously.
  • Strong communication, presentation, negotiation, and interpersonal skills.
  • Ability to operate effectively in a lean, fast-paced, and evolving biotechnology environment.
  • High degree of accountability, ownership, adaptability, and execution focus.

Communication & Interpersonal Skills
  • Excellent verbal, written, and presentation skills.
  • Ability to communicate complex operational information clearly and concisely to technical and non-technical audiences, including executive leadership.
  • Strong collaboration and relationship-building skills across internal teams and external partners.
  • Demonstrated ability to influence without authority and drive alignment across cross-functional stakeholders.

QUALIFICATIONS:
Education:
  • B.S./B.A. in Life Science or related discipline
  • Advanced degree (M.S./M.A., MPH, MHS, MBA) preferred

Experience:
  • B.A./B.S. with 10+ years of applicable industry experience (Clinical Operations) in drug development, or advanced degree with 6+ years of experience across both early (Phase 1 or 2) and/or late-stage (Phase 3)
  • 3+ years in a leadership role and with a minimum of 3+ years direct line management experience.
  • Relevant experience in clinical trial execution across all phases.

Other Qualifications/Skills:
    • Proven ability to recruit, retain, organize, and motivate clinical operations personnel
    • Ability to communicate to leadership team on Clinical Operations updates and priorities as well as to advocate for required budget and resources
    • Ability to manage and oversee large scale programs that have corporate-wide impact
    • Ability to develop and manage functional and clinical trial-specific budgets
    • Must be self-motivating; prioritize and manage a large volume of work; show attention to detail
    • Strong interpersonal skills are essential as this individual will partner with various team members and functional groups for clinical trials and business performance
    • Thorough knowledge and understanding of FDA and ICH Guidelines, GCP, medical terminology, and clinical trials
    • Ability to be flexible and adaptable to changing business needs
    • Excellent communication and interpersonal skills
    • Must be able to write clearly and summarize information effectively
    • Must be able to present complex information to various audiences

Base salary compensation range: $225,000 - 250,000
Please note, the base salary compensation range and actual salary offered to the final candidate depends on various factors: candidate's geographical location, relevant work experience, skills, and years of experience.
4DMT provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, genetic information, marital status, status as a covered veteran, and any other category protected under applicable federal, state, provincial and local laws.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

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