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Biotech Startup Director Clinical Operations Jobs

Rocket Pharmaceuticals

NJ · On-site

$196 - $261/hr

Rocket Pharma is a fully integrated, late-stage biotechnology company advancing gene therapies with ... Position Summary The Director, Clinical Operations - AAV, reporting to the VP, Clinical Operations ...

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Biotech Startup Director Clinical Operations information

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How much do biotech startup director clinical operations jobs pay per year?

As of Aug 10, 2026, the average yearly pay for biotech startup 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 does a biotech startup director clinical operations do?

A Biotech Startup Director of Clinical Operations oversees the planning, execution, and management of clinical trials at an emerging biotechnology company. Their responsibilities include building and leading the clinical operations team, ensuring regulatory compliance, developing trial protocols, managing budgets and timelines, and collaborating with cross-functional departments like regulatory affairs, medical affairs, and R&D. They play a critical role in advancing new therapies from early-stage trials through to later phases, often in a fast-paced and resource-limited startup environment.

What are some common challenges faced by a biotech startup director clinical operations, and how can they be addressed?

A Biotech Startup Director of Clinical Operations often faces challenges such as limited resources, rapidly shifting priorities, and the need to establish efficient processes from the ground up. Balancing the demands of regulatory compliance with the agility required in a startup environment can be particularly complex. Success often depends on building a strong, cross-functional team, leveraging external partnerships, and proactively communicating with stakeholders to ensure alignment and timely decision-making. Adapting quickly and fostering a culture of collaboration are essential to overcoming these hurdles.

What are the key skills and qualifications needed to thrive as a biotech startup director clinical operations?

To excel as a Biotech Startup Director of Clinical Operations, you need a deep understanding of clinical trial management, regulatory compliance, and drug development, typically supported by an advanced degree in life sciences and significant industry experience. Familiarity with clinical trial management systems (CTMS), electronic data capture (EDC) platforms, and GCP certification is commonly required. Strong leadership, strategic thinking, and effective communication are essential soft skills for leading teams and collaborating with stakeholders. These competencies ensure that clinical trials are executed efficiently, safely, and in compliance with regulatory standards, which is crucial for the success and growth of a biotech startup.

What is the difference between Biotech Startup Director Clinical Operations vs Clinical Project Manager?

AspectBiotech Startup Director Clinical OperationsClinical Project Manager
ResponsibilitiesOversees all clinical operations, strategic planning, team leadership, and regulatory compliance in a biotech startup setting.Manages individual clinical trials, coordinates project activities, timelines, and budgets under supervision.
Required CredentialsTypically requires advanced degrees (e.g., MS, PhD), clinical research experience, and leadership skills.Requires a bachelor's or master's degree in life sciences or related field, with experience in clinical trial management.
Work EnvironmentFast-paced startup environment with cross-functional teams, high responsibility, and strategic focus.Structured environment within pharmaceutical or biotech companies, focusing on specific trial execution.

The Biotech Startup Director Clinical Operations holds a broader leadership role, overseeing multiple trials and strategic initiatives, while the Clinical Project Manager focuses on managing individual clinical studies. Both roles require clinical research experience, but the director position demands more leadership and strategic planning skills.

More about Biotech Startup Director Clinical Operations jobs
What cities are hiring for Biotech Startup Director Clinical Operations jobs? Cities with the most Biotech Startup Director Clinical Operations job openings:
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Biotech Startup Director Clinical Operations jobs near you
Infographic showing various Biotech Startup Director Clinical Operations job openings in the United States as of August 2026, with employment types broken down into 85% Full Time, 12% 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.

Director, Clinical Operations Excellence

Relay Therapeutics

Cambridge, MA • On-site

$163K - $233K/yr

Full-time

Posted 4 days ago

Job description

The Opportunity:
The Director, Clinical Operations Excellence will establish and advance scalable, fit-for-purpose operational capabilities that enable high-quality, inspection-ready clinical trial execution across Relay's portfolio, reporting to the VP, Clinical Operations Excellence. In a lean, matrixed biotechnology environment, this role will serve as both a strategic leader and hands-on contributor, partnering with study teams, functional stakeholders, CROs, and vendors to strengthen execution, simplify processes, develop actionable operational metrics and analytics, and proactively manage operational and quality risks. As the functional lead and business process owner for Risk-Based Quality Management (RBQM), this individual will be accountable for the implementation, adoption, and continuous improvement of Relay's RBQM framework in collaboration with relevant vendors and CROs. The role will ensure study teams apply quality risk management principles, leverage RBQM technologies, operational analytics, and data-driven oversight, and act on emerging risks in a timely and effective manner.
Your Role:
  • Clinical Operations Excellence: Lead portfolio-level process improvement and operational excellence initiatives that improve study execution, quality, consistency, efficiency, and inspection readiness.
  • Partner with Clinical Operations, Clinical Development, Medical, Biometrics, Quality, Regulatory, Safety, TMF, CROs, and external providers to ensure studies are operationally feasible, risk-informed, and consistently executed.
  • RBQM Leadership: Serve as Relay's RBQM subject matter expert and business process owner, accountable for the framework, governance, adoption, and continuous improvement of RBQM practices across studies.
  • Lead study teams through CtQ identification, critical data and process review, risk assessments, quality controls, KRIs, QTLs, mitigation planning, risk ownership, escalation pathways, and ongoing risk review.
  • Integrate RBQM into protocol development, study planning, vendor oversight, monitoring strategies, data review, governance forums, issue management, and inspection readiness.
  • Systems, Metrics, and Data-Driven Oversight: Build, review, and execute operational metrics and reporting capabilities that provide clear visibility into study execution, portfolio performance, quality trends, and areas requiring action.
  • Partner with study teams and functional stakeholders to interpret metrics, identify trends, support governance discussions, and translate insights into practical actions that improve execution and quality.
  • Vendor Oversight and Governance: Support execution of the vendor governance strategy by organizing and facilitating governance forums, tracking decisions and actions, supporting performance oversight, issue escalation, corrective action follow-up, quality trend review, and RBQM operationalization.
  • Process Excellence and Inspection Readiness: Develop and improve SOPs, work instructions, templates, playbooks, job aids, governance models, operational metrics, and inspection readiness standards.
  • Champion simple, scalable, quality-focused ways of working that support audit readiness, inspection preparation, CAPA development, root cause analysis, and continuous improvement.

Your Background:
  • BA/BS degree in Life Sciences, Nursing, Pharmacy, Public Health, or related discipline required; advanced degree preferred.
  • 8+ years of progressive Clinical Operations experience or equivalent experience, in biotechnology, pharmaceutical, or CRO organizations, including global Phase I-III oncology or other complex clinical development programs.
  • Demonstrated experience leading or implementing RBQM, operational strategy, or process improvement initiatives in a fast-paced, matrixed environment.
  • Strong expertise in study management, monitoring, vendor oversight, clinical trial execution, issue management, inspection readiness, and Quality Risk Management.
  • Experience with CtQ factors, critical data and processes, KRIs, QTLs, centralized monitoring, risk mitigation, and RBQM platforms.
  • Experience building, reviewing, and using operational metrics, dashboards, or reporting capabilities to support study execution, governance, and continuous improvement.
  • Strong knowledge of GCP, ICH E6(R3), ICH E8(R1), RBQM principles, FDA, EMA, and other applicable regulatory expectations.
  • Collaborative, hands-on, and comfortable operating in ambiguity, with excellent facilitation, analytical, communication, presentation, project management, and influencing skills.
  • Proven ability to present complex concepts clearly and persuasively.
  • Demonstrated ability to lead through influence and, where applicable, manage or mentor team members.
  • Strong stakeholder management, negotiation, and influencing capabilities.

Estimated Salary Range: [$163,000 - $233,000]
The range provided above is based on what we believe to be a reasonable estimate for this job at the time of posting. Actual base salary will depend on a number of factors, including but not limited to, a candidate's education, experience, skills and location.
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About Relay Therapeutics
Relay Therapeutics is a clinical-stage precision medicines company transforming the drug discovery process with the goal of bringing life-changing therapies to patients. Built on unparalleled insights into protein motion and how this dynamic behavior relates to protein function, we aim to effectively drug protein targets that have previously been intractable, with an initial focus on enhancing small molecule therapeutic discovery in targeted oncology. Our Dynamo platform integrates an array of leading-edge experimental and computational approaches to provide a differentiated understanding of protein structure and motion to drug these targets. We have built a world-class team of leading experts from each of these disciplines, and they are driven by a deep collaboration at every step of our drug discovery process.
Our team is equal parts fearless and relentless, with a shared passion for working collaboratively in intellectually stimulating environments. If you're excited by the challenge of putting protein motion at the heart of drug discovery and passionate about making a difference in the lives of patients, join us!

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