Associate Director/Director, Clinical Trial Manager

Kriya Therapeutics, Inc.; Morrisville (NC); On-site; USD 100,000 - 130,000; Full time

Job summary

A leading biopharmaceutical company is seeking an Associate Director/Director, Clinical Trial Manager to oversee clinical trials, manage vendors, and ensure compliance with regulations. This role requires strong leadership and communication skills, along with extensive experience in clinical trials management. Join a dynamic team focused on developing transformative gene therapies.

Qualifications

• 10+ years in pharma/biotech with 8+ years in clinical trials management.

Responsibilities

• Manage clinical trials, vendors, and sites.
• Ensure compliance with SOPs, ICH/GCP, and regulatory guidelines.
• Lead operational activities related to study start-up, conduct, and close-out.

Skills

Leadership

Communication

Resource Planning

Budget Negotiation

Project Management

Education

Bachelor’s degree or equivalent

Tools

EDC

CTMS

IRT systems

Microsoft Office

Job description

Associate Director/Director, Clinical Trial Manager

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About Kriya
Kriya is a biopharmaceutical company whose mission is to develop life-changing gene therapies for diseases affecting millions of patients around the world. We leverage our proprietary computational engine, in-house manufacturing infrastructure, and integrated design platform to engineer technologies and therapeutics with the potential to transform the treatment of a broad universe of diseases of high unmet need, with a focus on metabolic disorders, neurology, and ophthalmology. We are proud to have been named Triangle Business Journal’s Life Sciences 2024 “Best Private Company to Work For,” recognized by Forbes as one of “America’s Best Startup Employers of 2024,” and honored as one of BioSpace’s “2025 Best Places to Work.”

Who You Are
We are looking for an Associate Director/Director, Clinical Trial Manager for programs within our exciting pipeline. This role involves managing clinical trials, vendors, and sites, reporting to the SVP of Clinical Operations, and working closely with cross-functional teams to ensure compliance with SOPs, ICH/GCP, regulatory guidelines, and project timelines and budgets.

How You Contribute

• Provide primary clinical operational oversight to ensure studies are conducted according to SOPs and ICH GCP requirements.
• Participate in study budget preparation, contract negotiations, and invoice reviews.
• Lead operational activities related to study start-up, conduct, and close-out.
• Assist with clinical protocol development focusing on operational aspects.
• Manage CROs and clinical vendors as the main point of contact.
• Lead creation and amendments of informed consent forms, source documents, and related documents.
• Report on clinical project milestones and timelines.
• Participate in vendor selection and establish partnerships with CROs and key vendors.
• Build relationships with PIs and site staff, ensuring protocol compliance and deliverables.
• Contribute to data management activities, including eCRF creation and data cleaning.

Additional Responsibilities

• Lead cross-functional study team meetings.
• Coordinate with project management to maintain project timelines and escalate issues as needed.
• Collaborate with QA to stay updated on regulations and policies.
• Support SOP and process development, including metrics and communication platforms.

Education & Experience

• Bachelor’s degree or equivalent.
• At least 10+ years in pharma/biotech with 8+ years in clinical trials management.

Competencies

• Experience managing external vendors and working in virtual environments.
• Leadership in clinical trial or project management.
• Familiarity with EDC, CTMS, IRT systems; UAT experience preferred.
• Excellent communication and interpersonal skills.
• Resource planning and budget negotiation experience.
• Knowledge of ICH/GCP guidelines.
• Ability to work independently, multi-task, and manage time effectively.
• Willingness to travel domestically and internationally.
• Proficiency in Microsoft Office applications.
• Experience in gene therapy or metabolic disorders is a plus but not required.

Working Conditions

• Primarily office or home-based desk work.
• Extended sitting and computer use.
• Occasional travel and outside hours may be required.

Join Our Team

We value collaboration, leadership, and innovation. If you’re driven, energetic, and want to be part of a company with an entrepreneurial culture and bold vision, we invite you to apply.