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Protocol Development Jobs in New York (NOW HIRING)

Pathos Lab

Director, Clinical Science

Manhattan, NY · On-site

$200 - $240/hr

You own protocol development, data review, clinical document authorship, and site-level scientific support from study startup through closeout. You will work closely with Clinical Operations ...

Staffingine LLC

Sr. Principal Statistics

Paramus, NJ · On-site

The Senior Manager in Statistics responsible for perform statistical activities in clinical trials from protocol development to final study report and statistical activities in drug in-licensing ...

Pathos

Director, Clinical Science

New York, NY · On-site

$200K - $240K/yr

You own protocol development, data review, clinical document authorship, and site-level scientific support from study startup through closeout. You will work closely with Clinical Operations ...

Pathos

Director, Clinical Science

Manhattan, NY · On-site

$200 - $240/hr

You own protocol development, data review, clinical document authorship, and site‑level scientific support from study startup through closeout. You will work closely with Clinical Operations ...

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All JobsProtocol Development JobsProtocol Development Jobs in New York

Protocol Development information

See New York salary details

$31.7K

$58.4K

$88.6K

How much do protocol development jobs pay per year?

As of Aug 27, 2026, the average yearly pay for protocol development in New York is $58,441.00, according to ZipRecruiter salary data. Most workers in this role earn between $46,500.00 and $65,600.00 per year, depending on experience, location, and employer.

What is protocol development?

Protocol development refers to the process of designing and creating detailed plans, often called protocols, which outline the methodology and procedures for conducting research or clinical trials. This includes specifying objectives, study design, data collection methods, and regulatory requirements to ensure the study is scientifically valid and ethically sound. Protocol developers work closely with researchers, regulatory bodies, and stakeholders to ensure all aspects of the protocol meet industry standards and compliance guidelines.

What are the key skills and qualifications needed to thrive in protocol development, and why are they important?

To thrive in Protocol Development, you need a solid background in clinical research, regulatory requirements, and scientific writing, often supported by a degree in life sciences or a related field. Familiarity with tools such as clinical trial management systems (CTMS), electronic data capture (EDC), and knowledge of ICH-GCP guidelines is typically required. Strong attention to detail, project management, and effective communication skills help professionals excel in this role. These competencies ensure the creation of clear, compliant, and scientifically sound protocols that are essential for successful clinical trials.

What are the main challenges someone might face when starting in a protocol development role?

One of the main challenges in Protocol Development is quickly understanding complex technical standards and aligning them with organizational goals. New team members often need to collaborate closely with cross-functional teams, such as engineering, legal, and product management, to ensure protocols are both technically sound and compliant with industry regulations. Adapting to rapidly evolving technologies and maintaining clear documentation can also be demanding, but strong communication and a willingness to learn can help overcome these hurdles.

What is the difference between Protocol Development vs Clinical Research Associate?

AspectProtocol DevelopmentClinical Research Associate
Primary RoleDesigns and develops clinical trial protocolsMonitors clinical trials to ensure compliance and data integrity
Required SkillsKnowledge of clinical trial design, regulatory guidelines, and writing skillsMonitoring skills, regulatory knowledge, and communication skills
Work EnvironmentTypically in planning, development, and regulatory teamsOn-site or remote monitoring at clinical trial sites
CertificationsOften requires knowledge of GCP, regulatory affairsGCP certification often preferred

While Protocol Development focuses on creating and designing clinical trial protocols, Clinical Research Associates are responsible for monitoring and ensuring trial compliance at sites. Both roles are essential in clinical research but differ in their core responsibilities and work environments.

What are popular job titles related to Protocol Development jobs in New York?

For Protocol Development jobs in New York, the most frequently searched job titles are:

What job categories do people searching Protocol Development jobs in New York look for?

The top searched job categories for Protocol Development jobs in New York are:

Protocol Development jobs near you
Infographic showing various Protocol Development job openings in New York as of August 2026, with employment types broken down into 1% As Needed, 81% Full Time, 16% Part Time, and 2% Contract. Highlights an 90% Physical, 3% Hybrid, and 7% Remote job distribution, with an average salary of $58,441 per year, or $28.1 per hour.

Senior Director, Real World Evidence & Health Economics and Outcomes

New York, NY

Lexeo Therapeutics
Biotechnology Research and Development • 11 - 50 employees
Learn more about Lexeo Therapeuticsexternal

Full-time

Posted 28 days ago

Job description

Role Summary 

The Senior Director, Real World Evidence and Health Economics and Outcomes, is responsible for providing scientific input during protocol development, study design, oversight of clinical aspects of study conduct, and interpretation of study results through the final study report. The candidate will also be responsible for establishing rigorous assessment of real world data to assess the natural history of diseases and real world outcomes for LEXEO's early development and clinical portfolio.  The Senior Director, Real World Evidence and Health Economics and Outcomes will work closely with other members of the clinical development and operations teams, and relevant internal stakeholders to execute and deliver milestones. The successful candidate will be highly collaborative and motivated, with excellent knowledge of first-in-human clinical trial design, preferably with experience in gene or cell therapy, and experience developing RWE historical control and methods.  The candidate must also possess excellent leadership, communication, and organizational skills, be solution-oriented, exhibit high attention to detail and quality, and have strong initiative and execution to timelines.   

If you enjoy being a part of a growing team and an entrepreneurial environment in which your work will have a meaningful impact on clinical trial progress for novel gene therapies, we want to hear from you! 

Primary Responsibilities
  • Work in partnership with Medical Affairs, Regulatory, Clinical Development and relevant internal stakeholders to lead the development and execution of RWE strategies, protocol development, analysis plan development, implementation of analyses, interpretation of findings and dissemination/publication
  • Study concept development and execution of natural history of disease assessment for business and early and late development indications
  • Collaborate with Regulatory and Clinical Development to plan real world studies which can serve as natural history or external controls, or buttress the clinical studies for regulatory submissions
  • Strategic and executional support for cross-functional RWE initiatives including registries, natural history of disease for regulators, payers and clinicians
  • Contributes to creation of clinical development strategic plan, clinical trial design, electronic case report forms (eCRFs), and statistical analysis plans
  • Preparation (or oversight of vendor preparation) of data table, listings, figures, clinical study reports and clinical submission documents
  • Close collaboration with clinical operations team to oversee protocol feasibility assessments, site identification, review of provider specifications, and vendor evaluation
  • Close collaboration with clinical operations team to review relevant vendor, CRO and site scopes of work, study budgets, and plans or manuals related to study data, IVRS, central labs, etc.
  • Development of internal and external training materials and presentations
  • Review and analysis of interim and final clinical trial data, including summarizing potential safety and efficacy trends, for study documents including CSRs, IBs, and DSURs
  • Close collaboration with clinical development physician in strategic planning and conduct of investigator meetings and advisory boards
  • Close collaboration with clinical development physician in preparation of abstracts, manuscripts, presentations, and materials for external meetings as related to the protocol and/or clinical program
  • Oversight of scientific activities outsourced to vendors and clinical research organizations 
Required Skills and Qualifications
  • Relevant clinical or biomedical Ph.D. or relevant Pharmacy, Nursing or MSc/MRes degree
  • At least 10 years of exposure to drug development and real world medical research experience within the biopharmaceutical industry; candidates with only academic experience may be considered
  • Excellent knowledge of clinical trial design, statistics, and data review tools
  • Significant experience in development of protocols and case report forms
  • Ability to share scientific data effectively across functions and through presentations
  • Significant experience reviewing and analyzing clinical trial data to identify potential safety and efficacy trends
  • Experience in health economics and outcomes research; payer relevant models
  • Working knowledge of ICH and FDA GCP Guidelines
  • Experience with clinical studies, research collaborations and real world data assessments and use
  • Experience working in global regulatory and pharmacovigilance environments preferred
  • Demonstrated ability to think analytically and strategically, work independently and solve problems
  • Publications in peer reviewed journals for RWE and/or HEOR
  • Highly motivated, accountable, self-directed, and able to execute with attention to detail
  • Excellent communication and interpersonal relationship skills including negotiating and relationship management skills across multiple functions and with external vendors
  • Skilled at prioritizing tasks to deliver on deadlines in a highly collaborative and collegial work style
  • Patient-focused with a deep commitment to understanding patient needs
  • Gene therapy and/or rare disease experience in biotech company preferred
  • Enjoys being part of a growing team and fast-paced environment 
$264,500 - $330,000 a year
Compensation is dependent on qualifications and experience.

About LEXEO 

LEXEO Therapeutics is a clinical-stage genetic medicine company headquartered in New York City, pioneering cardiac genetic medicine candidates to treat the root causes of inherited cardiovascular diseases. Our lead program, LX2006, targets cardiomyopathy associated with Friedreich's Ataxia and anchors a broader pipeline addressing genetically defined conditions such as hypertrophic and arrhythmogenic cardiomyopathies. Backed by a strong financial foundation, LEXEO is positioned to translate groundbreaking science into durable clinical impact.

Our work culture is a hybrid model with 2 days/week in the New York City office and 3 days working from home.

LEXEO Therapeutics is an EEO employer committed to an exciting, diverse, and enriching work environment. 

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
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