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Associate Director Clinical Operations Jobs in Roxboro, NC

MSD

Associate Director, Operations

Durham, NC · On-site

We are seeking an Associate Director, Operations for a capital project start-up in Durham, North Carolina. The Associate Director will oversee a portion of the manufacturing team. The facility ...

Red Oak Recovery Center

Clinical Director

Durham, NC · Remote

$90K - $100K/yr

We are seeking a Clinical Director to add to our dynamic team. This position will support our ... Develop and implement policies and procedures to improve clinical operations and enhance patient ...

MSD

Associate Director, Engineering

Durham, NC · On-site

Lead integrated project teams across GES, Site Engineering, Operations, Quality, EHS, Maintenance ... Adaptability, Automation Systems, Capital Project Management, Change Management, Clinical ...

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All JobsAssociate Clinical Operations JobsAssociate Director Clinical Operations JobsAssociate Director Clinical Operations Jobs in Roxboro, NC

Associate Director Clinical Operations information

See Roxboro, NC salary details

$52.8K

$128.4K

$248.5K

How much do associate director clinical operations jobs pay per year?

As of Aug 23, 2026, the average yearly pay for associate director clinical operations in Roxboro, NC is $128,410.00, according to ZipRecruiter salary data. Most workers in this role earn between $89,700.00 and $152,600.00 per year, depending on experience, location, and employer.

What does an associate director clinical operations do?

An Associate Director of Clinical Operations oversees the planning, execution, and management of clinical trials within a pharmaceutical, biotechnology, or medical device company. They supervise clinical project teams, ensure regulatory compliance, manage budgets and timelines, and collaborate with cross-functional departments to deliver high-quality results. Their role is crucial in ensuring that clinical studies are conducted efficiently, safely, and in accordance with all applicable guidelines and standards.

How does an associate director clinical operations typically collaborate with cross-functional teams during a clinical trial?

An Associate Director of Clinical Operations regularly works alongside teams such as Regulatory Affairs, Data Management, Medical Affairs, and Biostatistics to ensure trials run smoothly and meet compliance standards. They coordinate project timelines, facilitate communication between departments, and address operational challenges as they arise. This collaborative approach helps to streamline decision-making, resolve issues quickly, and keep the clinical trial on track for successful completion.

What are the key skills and qualifications needed to thrive as an associate director clinical operations, and why are they important?

To thrive as an Associate Director Clinical Operations, you need expertise in clinical trial management, regulatory compliance, and strong leadership, typically supported by a degree in life sciences or a related field. Familiarity with clinical trial management systems (CTMS), GCP guidelines, and project management tools is essential, along with relevant certifications like PMP or ACRP. Exceptional communication, problem-solving, and team-building skills enable effective cross-functional collaboration and decision-making. These skills are vital for ensuring the successful planning, execution, and oversight of clinical trials while meeting regulatory and organizational goals.

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

AspectAssociate Director Clinical OperationsClinical Project Manager
ResponsibilitiesOversees multiple clinical trials, manages teams, and ensures regulatory complianceManages individual clinical projects, coordinates activities, and tracks progress
Required CredentialsBachelor's or higher in life sciences, often with experience in clinical operationsBachelor's in life sciences, with project management experience
Work EnvironmentSenior-level role within clinical operations teams, often in biotech or pharma companiesProject-focused role, working closely with cross-functional teams in clinical settings

The Associate Director Clinical Operations typically oversees multiple clinical trials and manages teams, requiring broader strategic oversight. In contrast, a Clinical Project Manager focuses on managing specific projects, ensuring timely execution. Both roles require relevant clinical experience, but the Associate Director role involves higher-level leadership and operational responsibilities.

What job categories do people searching Associate Director Clinical Operations jobs in Roxboro, NC look for?

The top searched job categories for Associate Director Clinical Operations jobs in Roxboro, NC are:

What cities near Roxboro, NC are hiring for Associate Director Clinical Operations jobs?

Cities near Roxboro, NC with the most Associate Director Clinical Operations job openings:

Associate Director Clinical Operations jobs near you

Associate Director or Director, Regulatory Strategy (Clinical & Nonclinical)

Atsena

Durham, NC • Remote

Full-time

Re-posted 22 days ago

Job description

Job Title: Associate Director or Director, Regulatory Strategy (Clinical & Nonclinical)
Department: Regulatory
Reports To: VP of Regulatory
Location: Remote or Onsite


Position Summary:

The Associate Director / Director, Regulatory Strategy (Clinical & Nonclinical) will lead global regulatory strategy and execution for the company’s gene therapy programs from early research through clinical development and commercialization. This individual will be responsible for developing nonclinical and clinical regulatory strategies, supporting regulatory submissions, and serving as the regulatory liaison to internal nonclinical and clinical teams.

This role requires strong experience in regulatory strategy for biologics or gene therapies and the ability to work cross-functionally with clinical development, clinical operations, nonclinical, quality and program leadership. This individual will also support interactions with global regulatory authorities such as the U.S. Food and Drug Administration and the European Medicines Agency.


Key Responsibilities:

Regulatory Strategy Development

  • Develop and implement global regulatory strategies for gene therapy programs from preclinical through clinical development and commercialization.
  • Provide regulatory guidance on nonclinical, clinical, and translational development plans.
  • Identify regulatory risks and propose mitigation strategies to support program timelines.
  • Contribute to overall product development strategy and lifecycle planning.

Regulatory Submissions

  • Lead preparation and submission of global regulatory filings including: INTERACT and PreINDs, INDs and IND amendments, CTAs and IMPDs, orphan drug designation applications, Fast Track, RMAT and other expedited program submissions
  • Ensure high-quality regulatory documentation aligned with agency expectations.

Health Authority Interactions

  • Prepare regulatory briefing documents and support agency meetings.
  • Serve as a subject matter expert for interactions with agencies including the FDA and EMA.
  • Coordinate and author responses to health authority questions and information requests.

Cross-Functional Collaboration

  • Partner closely with internal teams including: Clinical Development, Clinical Operations, Nonclinical, Quality
  • Serve as a regulatory representative on cross-functional program teams.
  • Ensure alignment of development plans with global regulatory requirements.

Regulatory Intelligence & Compliance

  • Monitor evolving regulations and guidance related to gene therapies and biologics.
  • Interpret guidance documents and communicate regulatory expectations internally.
  • Contribute to development of internal regulatory processes and best practices.


Qualifications:

Education

  • PhD, PharmD, MD or MS in life sciences, molecular biology, pharmacology, or related discipline.

Preferred Qualifications

  • Direct experience with AAV, lentiviral, or other gene therapy platforms.
  • Experience with rare disease development programs.
  • Experience with global regulatory submissions including US and EU.
  • Prior participation in regulatory agency meetings.

Associate Director Experience

  • 7–10 years of experience in regulatory affairs within biotech or pharmaceutical industry.
  • Experience supporting INDs, CTAs, and early clinical development.

Director Experience

  • 10–15+ years of experience in regulatory affairs with demonstrated leadership of regulatory strategy for development programs.
  • Proven experience leading regulatory submissions and interactions with agencies.

Knowledge & Skills

  • Strong understanding of regulatory pathways for biologics and gene therapy products.
  • Experience with nonclinical regulatory requirements for biologics.
  • Excellent regulatory writing and communication skills.
  • Ability to lead cross-functional teams and influence program strategy.
  • Strong project management and organizational skills.

Key Competencies

  • Strategic thinking and problem solving
  • Strong scientific and regulatory knowledge
  • Cross-functional leadership and collaboration
  • Clear communication and influence
  • Ability to work in a fast-paced, early-stage biotech environment