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Biotech Startup Director Clinical Operations Jobs

Alira Health

Summary The Senior Director, Clinical Operations, is a key member of the Executive Leadership Team ... The ideal candidate will possess biotech or pharmaceutical industry background, demonstrated ...

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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.

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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.

Associate Director, Clinical Operations

Cogent Biosciences

Waltham, MA • On-site, Remote

$185K - $215K/yr

Full-time

Medical, Dental, Vision, Retirement, PTO

Posted 19 days ago

Job description

Who We Are:

Cogent Biosciences is a publicly traded biotechnology company focused on developing novel precision therapies to treat a broad range of patients with unmet medical needs. Cogent's lead program, bezuclastinib, is designed to selectively and potently inhibit exon 17 mutations found within the KIT receptor tyrosine kinase, including KIT D816V. KIT D816V is responsible for driving a rare and serious condition called Systemic Mastocytosis, and exon 17 mutations are also found in patients with gastrointestinal stromal tumors (GIST), a type of cancer with strong dependence on oncogenic KIT signaling. Bezuclastinib has exhibited promising initial data across all three trials: APEX in AdvSM, SUMMIT in NonAdvSM and PEAK in GIST, including an encouraging safety profile across 600+ patients in single agent and combination dosing. 

The Role:

Cogent Biosciences is seeking an experienced and highly motivated Associate Director, Clinical Operations to serve as a key operational leader across our clinical development programs. Reporting to the Senior Director, Head of Clinical Operations, this individual will function as both a hands-on study leader and a strategic clinical operations partner, helping drive execution and operational excellence across multiple stages of development. 

 This role is ideal for someone who enjoys balancing operational detail with strategic program oversight-an individual who can independently lead complex global studies while also contributing to broader Clinical Operations strategy, portfolio planning, process improvement, and cross-functional decision-making. 

 The successful candidate will be accountable for the planning, execution, oversight, and delivery of clinical trials across early-stage development programs, with opportunities to support later-stage development as programs advance. This individual will serve as a trusted partner to the Head of Clinical Operations and will be expected to identify risks proactively, influence key stakeholders, and help scale operational excellence within a growing clinical organization. 

We are seeking someone who brings strong operational expertise, a sense of ownership, intellectual curiosity, and a willingness to work at both the strategic and tactical levels. The ideal candidate is equally comfortable reviewing site-level enrollment challenges, leading vendor governance discussions, influencing development strategy teams, and driving complex cross-functional initiatives. 

 

Responsibilities:

    • Serve as the clinical operations lead for one or more global clinical studies, ensuring delivery of study objectives on timeline, budget, and quality expectations. Provide strategic oversight of CROs and vendors, ensuring accountability, quality, and operational execution. 
    • Develop and review study performance metrics and drive corrective and preventive actions when needed. Evaluate and analyze site trends, evaluate study risks and mitigation strategies, and work with the cross-functional team in the review clinical data. 
    • Develop strong partnerships with external stakeholders while maintaining sponsor ownership of study execution. Serve as Clinical Operations representative on Strategy Teams, and coordinate and lead study team meetings and update the cross-functional Team on timelines and milestones for the study.  
    • Contribute to the development of study documentation including protocol review, creating study manuals, ICFs, designing CRFs, and ensure proper team and external training. 
    • Provide input to Clinical Study Reports and Investigator Brochures, including data cleaning, listing review, and report writing. 
    • Support the evaluation of study vendors, including negotiation of contracts and budgets with CROs, clinical sites and vendors 
    • Perform clinical research site activities, such as onsite or remote monitoring, co-monitoring, training, motivational, and sponsor oversight visits, as needed 
    • Ensure that study documentation is maintained according to applicable regulations, industry accepted standards, and SOPs that govern clinical studies both in the field and in-house. 
    • Collaborate with Clinical, Regulatory, and Quality team members to ensure compliance of department/study activities with FDA regulations, guidelines, and principles of ICH GCP and company SOPs. 
    • Limited travel possible to clinical sites for investigator and site engagement, with potential to travel  (~25%). 

Qualifications:

    • BS/BA Degree or equivalent in science or a health-related field is preferred 
    • Minimum 6-7+ years of relevant industry clinical development experience  
    • Experience with complex therapeutic platforms  
    • Multi-phase clinical trials  
    • Experience with all aspects of trial and site startup and vendor selection and management, study management, and monitoring 
    • Familiarity with clinical data review and data management processes 
    • Excellent knowledge of GCP, ICH, and FDA regulations 
    • Experience with SOP review and development 

Salary Range:

$185,000- $215,000USD 

Target Bonus: 20%
Exact compensation will vary based on skills, experience, and location.
Our Locations

Waltham, MA: Our headquarters is located in the Greater Boston life sciences community, with an open, collaborative office environment designed to support teamwork and connection. Employees benefit from convenient on-site amenities, including free on-site parking and gym facilities in the building. 

Boulder, CO: Our Boulder location is home to Cogent's discovery research organization and a key scientific hub with strong leadership based on site. Situated in the greater Denver-Boulder biopharmaceutical corridor, this office plays a central role in advancing our discovery efforts and pipeline. 

Our Offer To You 

At Cogent Biosciences, we offer a competitive salary, bonus, and ongoing stock awards, alongside a benefits package that sets us apart. We cover 100% of medical, dental, and vision premiums for you and your family, and help reduce out-of-pocket costs by funding up to 75% of in-network deductibles. Our benefits also include a 401(k) match with immediate vesting, generous paid time off, 12 weeks of fully paid parental leave, paid family and medical leave for all employees regardless of location, and company-paid short-term disability coverage for up to 20 weeks. Additional perks like wellness programs, tuition reimbursement, and inclusive family-forming support help you thrive at work and beyond. 

We are proud to be an Equal Opportunity Employer. Our goal is to have a diverse workforce. We do not discriminate on the basis of race, age, color, religion, national origin, gender, sexual orientation, gender identity or expression, veteran status or disability, or any other status protected under federal, state, or local law. All employment is decided on the basis of qualifications, merit, and business need. 

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