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Protocol Development Jobs (NOW HIRING)

Systimmune

Clinical Development Physician

Princeton, NJ · On-site

$200K - $300K/yr

You will also have the opportunity to participate in the protocol development, clinical development plan, strategic discussion and cross alliance discussion. This will be an associate director or ...

Galaxy

Protocol Director

Identify where emerging protocol developments represent material opportunities or threats for the business. Examples would be new L1s, staking mechanisms, oracle integrations, cross-chain primitives ...

Loyal

Senior Director, Clinical Development

Develop protocols, investigator brochures, SAP inputs, and essential documents tailored for ... Work tightly with: * R&D to vet new drug targets and mechanisms and interpret pre-clinical data

Oran Inc

Clinical SME I

Herndon, VA · Remote

Support protocol development, study design, and safety review processes. * Evaluate inclusion/exclusion criteria, endpoints, and risk-benefit assessments. * Collaborate with clinical, regulatory, and ...

Oran, Inc.

Clinical SME I

Herndon, VA · On-site

Support protocol development, study design, and safety review processes. * Evaluate inclusion/exclusion criteria, endpoints, and risk-benefit assessments. * Collaborate with clinical, regulatory, and ...

Oran Inc

Clinical SME I

Herndon, VA · Remote

Support protocol development, study design, and safety review processes. * Evaluate inclusion/exclusion criteria, endpoints, and risk-benefit assessments. * Collaborate with clinical, regulatory, and ...

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Protocol Development information

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$29K

$53.4K

$81K

How much do protocol development jobs pay per year?

As of Jun 26, 2026, the average yearly pay for protocol development in the United States is $53,418.00, according to ZipRecruiter salary data. Most workers in this role earn between $42,500.00 and $60,000.00 per year, depending on experience, location, and employer.

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 does protocol mean?

In protocol development, a protocol is a detailed set of procedures and guidelines that define how data is collected, transmitted, and managed in a research or clinical setting. It ensures consistency, safety, and compliance across studies or projects, often requiring careful documentation and review by regulatory bodies.

What is a protocol in healthcare?

In healthcare, a protocol is a detailed plan or set of guidelines that healthcare professionals follow to ensure consistent and effective patient care. Protocols are used to standardize procedures, improve safety, and guide clinical decision-making, often based on evidence-based practices and requiring regular review and updates.

What are the 4 types of protocols?

In protocol development, the four main types are communication protocols, which define data exchange rules; security protocols, ensuring data protection; operational protocols, outlining procedures and workflows; and compliance protocols, ensuring adherence to regulations. Developing these protocols requires understanding of technical standards, industry requirements, and often involves collaboration with stakeholders.

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 is protocol and example?

In protocol development, a protocol is a detailed set of procedures and standards that guide how data is collected, processed, and communicated in research or clinical trials. An example is the Clinical Data Management Protocol, which outlines data collection methods, quality checks, and compliance requirements to ensure consistency and accuracy. Developing protocols requires attention to detail, regulatory knowledge, and collaboration with stakeholders.

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 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.
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Protocol Development jobs near you
Clinical Development Physician

Clinical Development Physician

SystImmune, Inc

Princeton, NJ • On-site

$200K - $300K/yr

Full-time

Medical, Dental, Vision, Retirement, PTO

Posted 25 days ago

Job description

SystImmune is a leading and well-funded clinical-stage biopharmaceutical company located in Redmond, WA and Princeton, NJ. It specializes in developing innovative cancer treatments using its established drug development platforms, focusing on bi-specific, multi-specific antibodies, and antibody-drug conjugates (ADCs). SystImmune has multiple assets in various stages of clinical trials for solid tumor and hematologic indications. Alongside ongoing clinical trials. SystImmune has a robust preclinical pipeline of potential cancer therapeutics in the discover and IND-enabling stages, representing cutting-edge biologics development. We offer an opportunity for you to learn and grow while making significant contributions to the company's success.
The Clinical Development Physician will be a key integral member of the clinical development team, serving as a medical director/ monitor for one or more oncology trials. Reporting to the Executive Director, Clinical Development, you will be responsible for the clinical oversight, medical monitoring, and execution of one or two key assets in Phase 1 to 3 clinical trials in solid tumor or hematology indications. You will act as the primary clinical development contact between sites/ principal investigators, CRO and the company, ensuring that study conduct aligns with the clinical development protocol, regulatory requirements, and safety standards. You will also have the opportunity to participate in the protocol development, clinical development plan, strategic discussion and cross alliance discussion. This will be an associate director or director level position with high leadership visibility and significant growth potential in a highly dynamic team within a rapidly growing biotech company
Key Responsibilities
1. Clinical Study Leadership & Design
  • Support the Executive Director in the design and refinement of clinical protocols, amendments, and informed consent documents.
  • Lead the development of key clinical documents, including Investigator Brochures (IB), Study Manuals, and Clinical Study Reports (CSR).
  • Ensure study-level execution aligns with the Clinical Study Protocols.

2. Medical Monitoring & Safety Oversight
  • Serve as the primary Medical Monitor (or coordinate with external monitors) to perform real-time data reviews, assess patient eligibility, and manage safety queries.
  • Lead the clinical review of safety data (SAEs, AEs, and laboratory trends) to identify potential signals and ensure patient safety across sites with the Safety Lead.
  • Collaborate with Pharmacovigilance and Data Management to ensure the "cleanliness" and integrity of clinical databases for interim and final analyses.

3. Cross-Functional Coordination & Alliance Support
  • Support Cross-Functional Discussion with Clinical Operations, Biostats, Regulatory, and Medical Writing.
  • Support Alliance Management activities by preparing technical updates and data summaries for partners.
  • Provide clinical expertise to CROs and external vendors to ensure high-quality deliverables and adherence to timelines.

4. Regulatory & Scientific Communication
  • Assist in the preparation of Health Authority briefing packages (FDA/EMA) and participate in regulatory interactions as the study-level expert.
  • Support the development of abstracts, posters, and manuscripts for major congresses (ASCO, ASH and ESMO).
  • Lead site-initiation visits (SIVs) and Investigator Meetings to ensure PIs and site staff are fully aligned on study protocols

Qualifications
  • Education: MD or equivalent with clinical training; oncology or hematology subspeciality training highly preferred
  • Experience: Medical oncology/hematology fellowship with 1 to 3+ years of clinical development experience in the academic setting and/or biotech/pharmaceutical industry
  • Technical Skills: Experience in medical monitoring, clinical protocol development, and clinical database review.
  • Execution Mindset: Demonstrated ability to multi-task and execute a task independently or with minimal supervision under tight deadlines (e.g., meeting database cut targets).
  • Communication: Strong and open communication skills to align internal stakeholders and external investigators.

Compensation and Benefits:
The expected base salary range for this position is $200,000 - $300,000 annually. Actual compensation will be based on a variety of factors, including but not limited to a candidate's qualifications, experience, and skills.
SystImmune is a leading and well-funded biotech company with a bright future. We offer an opportunity for you to learn and grow while making significant contributions to the company's success. SystImmune offers a comprehensive benefits package including: 100% paid employee premiums for medical/dental/vision, also STD, LTD, a 401(k) plan with a 50% company match of up to 3% and a vesting schedule of only 5 years, 15 PTO days per year, sick leave, plus 11 paid holidays and MORE.
We offer an opportunity for you to learn and grow while making significant contributions to the company's success.
SystImmune is an Equal Opportunity Employer. We welcome diverse talent and encourage all qualified applicants to apply.

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