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Study Director Jobs in Raleigh, NC (NOW HIRING)

implaion

Senior/Director - Regulatory Affairs

Durham, NC

$144K - $191K/yr

Director / Senior Director, Regulatory Affairs About the Role The company is seeking a Director or ... Support clinical study activities, including engaging with CROs as needed. * Build and roll out ...

Allucent

Director, Clinical Pharmacology

Cary, NC · Remote

As a Director, Clinical Pharmacology at Allucent, you are responsible for independently leading ... Autonomously lead the design, analysis, and interpretation of clinical pharmacology studies ...

Allucent

Director, Clinical Pharmacology

Cary, NC · On-site +1

As a Director, Clinical Pharmacology at Allucent, you are responsible for independently leading ... Autonomously lead the design, analysis, and interpretation of clinical pharmacology studies ...

Allucent

Director, Clinical Pharmacology

Cary, NC · Remote

As a Director, Clinical Pharmacology at Allucent, you are responsible for independently leading ... Autonomously lead the design, analysis, and interpretation of clinical pharmacology studies ...

M3USA

Director of Business Development

Raleigh, NC · On-site +1

Conducting studies since 1984, M3 Wake Research owns a proprietary patient database of potential ... The Director of Business Development leads the growth and management of key strategic partner ...

M3USA

Director of Business Development

Raleigh, NC · Remote

Conducting studies since 1984, M3 Wake Research owns a proprietary patient database of potential ... The Director of Business Development leads the growth and management of key strategic partner ...

UNC HEALTH

Director Clinical Research

Raleigh, NC · On-site

Provides study portfolio oversight, including review of feasibility assessments, study selection, activation timelines, and startup processes. Monitors key program metrics such as enrollment, audit ...

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Study Director information

See Raleigh, NC salary details

$43.7K

$124.8K

$226K

How much do study director jobs pay per year?

As of Jul 16, 2026, the average yearly pay for study director in Raleigh, NC is $124,783.00, according to ZipRecruiter salary data. Most workers in this role earn between $56,400.00 and $183,200.00 per year, depending on experience, location, and employer.

What is the highest paying job in research?

In research, senior roles such as Principal Investigator, Research Director, or Chief Scientific Officer tend to be the highest paying, often earning six-figure salaries. These positions typically require advanced degrees, extensive experience, and leadership skills in specialized fields like pharmaceuticals, biotechnology, or data science.

What is the difference between Study Director vs Laboratory Manager?

AspectStudy DirectorLaboratory Manager
CredentialsTypically requires advanced degrees (e.g., MS, PhD) and relevant certificationsRequires relevant degrees and management experience, but not necessarily advanced research credentials
Work EnvironmentLeads specific research or regulatory studies, often in contract labs or pharmaceutical companiesOversees daily lab operations, staff, and compliance across multiple projects
Industry UsageCommonly used in GLP, clinical, and research settingsUsed broadly in laboratory settings across industries

The Study Director focuses on designing, overseeing, and ensuring the integrity of specific studies, often requiring scientific expertise. The Laboratory Manager handles overall lab operations, staff management, and compliance. Both roles are essential but differ in scope and responsibilities.

What is a Study Director?

A Study Director is the individual responsible for the overall conduct of a scientific study, particularly in regulated environments such as pharmaceuticals, chemicals, or environmental research. They oversee the planning, execution, and reporting of studies to ensure they comply with regulatory standards, such as Good Laboratory Practice (GLP). The Study Director acts as the main point of control and communication, coordinating among team members and ensuring that the study meets its scientific and regulatory objectives. Their role is critical for the integrity and quality of the data generated.

How does a Study Director typically collaborate with cross-functional teams during a research project?

As a Study Director, you play a central role in coordinating research activities by regularly collaborating with scientists, technicians, quality assurance personnel, and regulatory teams. You are responsible for ensuring all team members are aligned on study objectives, timelines, and compliance requirements. Effective communication and leadership are essential, as you facilitate meetings, delegate tasks, and resolve issues that arise to keep the project on track. This collaborative environment not only fosters professional growth but also provides valuable exposure to various scientific and operational domains within the organization.

What Is the Job of a Study Director?

As a study director, your job is to manage studies, analyze results, and interpret reports so you can deliver a summary of the findings. This work has three categories. First, on the technical side, your job includes creating the plan for the study, coordinating with other scientists, and overseeing data collection. In the administrative role, you monitor junior employees and ensure each investigation finishes within budgetary constraints. In the compliance role, you ensure that each study happens under strict safety and ethics protocols. You may be asked to run multiple studies at the same time, adding to the complexity of this position.

How to become a study director?

To become a study director, typically a candidate needs a bachelor's degree in a scientific field such as biology, chemistry, or related disciplines, along with several years of experience in laboratory or research settings. Advanced roles often require a master's or doctoral degree and knowledge of Good Laboratory Practices (GLP) and regulatory requirements. Developing strong project management, leadership skills, and familiarity with relevant testing methods are also important for this role.

How much do research directors make in the US?

Research directors, including study directors in research settings, typically earn a median annual salary of around $80,000 to $120,000 in the US, depending on experience, industry, and location. They often require advanced degrees and strong project management skills to oversee research projects effectively.

What are the key skills and qualifications needed to thrive as a Study Director, and why are they important?

To thrive as a Study Director, you need a solid background in scientific research methods, regulatory compliance, and study protocol development, usually supported by an advanced degree in life sciences or a related field. Familiarity with laboratory information management systems (LIMS), Good Laboratory Practice (GLP) standards, and project management tools is highly valued. Strong leadership, attention to detail, and effective communication are crucial soft skills for managing cross-functional teams and ensuring study integrity. These competencies are vital to ensure regulatory adherence, data accuracy, and successful project outcomes in research environments.

What is the role of a study director?

A study director is responsible for designing, planning, and overseeing scientific studies, ensuring they comply with regulatory standards such as Good Laboratory Practice (GLP). They coordinate research activities, analyze data, and prepare reports to support product development or safety assessments.
More about Study Director jobs
What are the most commonly searched types of Study jobs in Raleigh, NC? The most popular types of Study jobs in Raleigh, NC are:
What are popular job titles related to Study Director jobs in Raleigh, NC? For Study Director jobs in Raleigh, NC, the most frequently searched job titles are:
What job categories do people searching Study Director jobs in Raleigh, NC look for? The top searched job categories for Study Director jobs in Raleigh, NC are:
What cities near Raleigh, NC are hiring for Study Director jobs? Cities near Raleigh, NC with the most Study Director job openings:
Study Director jobs near you
Infographic showing various Study Director job openings in Raleigh, NC as of July 2026, with employment types broken down into 100% Full Time. Highlights an 100% In-person job distribution, with an average salary of $124,783 per year, or $60 per hour.
Director (Senior Director), Regulatory Affairs

Director (Senior Director), Regulatory Affairs

SHATTUCK LABS, INC.

Durham, NC • On-site

$190K - $260K/yr

Full-time

Medical, Retirement

Re-posted 17 days ago

Job description

About us

Shattuckians are a diverse group of physicians, scientists, drug developers and protein engineers that are linked through our shared desire to build transformative medicines for patients suffering from life-altering diseases. We are experts in the biology of TNF receptors, including DR3, and have assembled one of the most experienced teams in the industry with regard to understanding the immuno-biology of TNF receptor agonists and antagonists.


Summary

The Director (Senior Director), Regulatory Affairs will be responsible for contributing to the development and overseeing the implementation of global regulatory strategies for assigned programs in alignment with and in compliance with local and regional requirements, and company policies. This role is intended to be the key program team representative from Regulatory Affairs for global programs just prior to Phase 1 through completion of Phase 3. This role will also ensure effective communication and coordination with business partners within and outside of the company, and with regulatory authorities worldwide. Included among the necessary activities are: oversight of regulatory CRO activities, planning and leading: meetings with regulatory authorities, compilation and submission of high-quality INDs, CTAs, BLAs/MAAs, meeting packages, responses to requests for information, amendments, and required elements such as safety reports, annual reports. This position will be onsite in Durham, NC and the role level will be commiserate on candidate's experience.


Responsibilities

  • Provide regulatory strategic input for global drug development projects, including but not limited to regulatory requirements, opportunities for expedited development, timing and content of agency interactions to support successful development programs.
  • Lead the preparation of regulatory submissions, ensuring the planning, coordination, preparation, and review of all submissions to global regulatory authorities including INDs, CTAs, BLAs, MAAs, amendments, responses to information requests and questions, safety reports, and annual updates/DSURs for assigned projects.
  • Interpret and communicate regulatory expectations to stakeholders in order to execute program objectives in compliance with applicable regulations.
  • Maintain an awareness and apply a comprehensive understanding of relevant regulations and guidelines to enhance probability of regulatory success and regulatory compliance.
  • Ensure that company and project team objectives and timelines are supported by regulatory deliverables.
  • Provide de-risking development strategies and evaluate opportunities to accelerate development in a fast-paced environment.
  • Represent Regulatory Affairs on global project teams, sub-teams, and external alliances.
  • Provide oversight of Regulatory staff at CRO executing clinical trials.
  • Provide support to clinical study related activities, including interacting with CROs as needed.
  • Develop and implement data management strategies aligned with company objectives.

  • Work as a member of a team, fostering constructive working relationships with internal and external colleagues.


Qualifications and skills

  • Bachelor’s Degree in clinical, scientific, medical or industry-related discipline is required; Advanced degree (MS, PharmD, PhD) preferred.
  • Minimum of at least 8 years experience as a regulatory professional in the bio/pharmaceutical industry, including experience with successful interactions directly with regulatory agencies.
  • Proven track record of successful regulatory submissions in the US and Europe, including major submissions (e.g., IND, CTA, BLA, NDA), and management of active programs (e.g., annual reports, safety reporting).
  • Excellent knowledge of FDA, European Agencies and ICH regulations and guidance documents, and an ability to discern regulatory requirements in additional countries.
  • Knowledge of drug development, and regulatory aspects of clinical study design, biostatistics, pharmacokinetics.
  • Exercises good judgement in elevating and communicating potential or actual issues to line management.
  • Proven track record of effective collaboration with multi-faceted project teams.
  • Excellent written and oral communication skills with an ability to clearly articulate regulatory viewpoints to diverse audiences.
  • Excellent interpersonal skills.
  • Formatting skills in MS Word.
  • Ability to work independently in a highly dynamic drug development environment.
  • Capable of multi-tasking, setting priorities, and meeting timelines.
  • Strong project management skills and drive for excellence.


Preferred, Additional Qualifications and skills

  • Experience in a Biotechnology company.
  • Familiarity with regulatory aspects of biologics manufacturing, including prior oversight of and responsibility for submissions that include CMC documentation.
  • Experience with inflammatory bowel disease drug development.
  • Scientific background in immunology, cell biology, preclinical assays
  • Document formatting to ensure suitability for regulatory submission gateways.
  • Experience in both early and late stage drug development.
  • Recent experience with BLA, NDA, MAA.
  • Experience with EU-CTR, IVDR, FDA NextGen Portal.


Employee benefits

  • Competitive salary and health benefits, 401K.
  • Opportunities for training and career advancement.
  • Collaborative and inclusive work environment.
  • Access to cutting-edge research and technology.


Note to External Recruiters

Our Human Resources department manages all open positions and candidate recruitment. We ask that recruiters not contact employees or hiring managers directly to present candidates or solicit business. We will consider failure to comply with this request when determining whether to enter a professional relationship with a recruiting agency. The submission of unsolicited resumes does not create any obligations for Shattuck Labs, implied or otherwise.