Full-Time Director, Clinical Trials & Programs

Eurofins Transplant Genomics Inc. (ETG) is a molecular diagnostics company focusing on improving organ transplant outcomes through non-invasive biomarker monitoring. ETG's products include whole blood gene expression and donor-derived cell-free DNA tests for kidney and liver transplant patients to rule out rejection.

Basic Function and Scope of Responsibility: The Director of Clinical Trials will oversee the clinical studies program. This includes leading or assisting in protocol development, integrating functional activities across internal teams, clinical sites, and vendors to meet project milestones and budget. The role also involves identifying and resolving project obstacles to achieve corporate goals.

Responsibilities:

• Develop or co-develop study protocols, including proposals and consultations with Key Opinion Leaders (KOLs).
• Provide regular status updates, strategic insights, and operational plans to senior management.
• Oversee clinical trial site management (qualification, initiation, monitoring, source documentation, close-out) in conjunction with a CRO.
• Train clinical team members and study site personnel, organizing Investigator meetings.
• Advise on logistical issues and protocol design.
• Oversee data clarification and ensure database locking on schedule.
• Coordinate protocol and Informed Consent Form (ICF) preparation and updates.
• Assist in regulatory document preparation (IDEs, IDE annual updates, PMAs).
• Contribute to clinical study report writing and review.
• Develop and update Standard Operating Procedures (SOPs) for compliance.
• Ensure all trials comply with Good Clinical Practices (GCP).
• Approve GCP documents.
• Develop work proposals, select and oversee CROs and laboratory vendors, negotiating clinical contracts.
• Develop and manage clinical trial budgets.
• Provide timely updates to senior management on progress, changes in scope, schedule, and resources.
• Other duties as assigned.

Qualifications:

• Minimum 8+ years of clinical trial experience in biotech, pharmaceutical, or relevant CROs.
• Broad understanding of the clinical development process, preferably with Phase II, Phase III, and regulatory filings (IDEs, PMAs, etc.)
• Experience with electronic data capture systems is preferred.
• International clinical development experience is a plus.
• Strong interpersonal, communication (written and verbal), and organizational skills.
• Fluent in English.
• Proficient with MS Office Suite (Word, Excel, PowerPoint, Outlook) on Windows.
• Ability to work independently and collaboratively.

Compensation: $120,000 - $185,000/year

Schedule: Monday-Friday, 8:00 AM - 5:00 PM, plus potential travel (up to 50%).

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