Director, Clinical Trials & Programs

Summary

Join Eurofins Transplant Genomics Inc. as the Director of Clinical Trials and lead the operation and oversight of the clinical studies program. You will be responsible for protocol development, integrating functional activities across teams, and ensuring timely and budget-compliant project completion. This role involves managing clinical study staff, mentoring team members, and identifying solutions to project obstacles. You will oversee clinical trial site management, train clinical team members, and advise on logistical and protocol design matters. The position requires significant experience in clinical trials and a strong understanding of Good Clinical Practice (GCP).

Requirements

• Requires a minimum of 8 or more years of clinical trials experience in biotech, pharmaceutical or relevant clinical CRO experience
• Broad understanding of the clinical development process
• Well versed in Good Clinical Practice
• Strong interpersonal, communication (written and verbal) skills, and organizational skills
• Demonstrated ability to work independently as well as part of a multi-functional study team
• Fluent in English
• Able to perform routine assignments with general instructions and new assignments with detailed instructions
• Able to motivate a team to work effectively within a changing environment
• Able to solve problems under pressure
• Self-motivated and able to work effectively in a matrix/team environment
• Excellent interpersonal skills, with ability to interact effectively and work efficiently with people at all levels in an organization
• Ability to keep sensitive information confidential
• Proficient with MS Office (Word, Excel, PowerPoint, Outlook) on Windows operating system

Responsibilities

• Develop or co-develop study protocols, including protocol proposals and consultation with Key Opinion Leaders (KOLs)
• Provide regular status updates of milestone targets to senior management, strategic insights toward achievement of milestones and translate strategies into operational plans for the global clinical trial study team, vendors and clinical sites
• Oversee clinical trial site management in conjunction with selected CRO, including site qualification, site initiation, monitoring oversight, source documentation, and study close-out
• Thoroughly train clinical team members in the clinical trial process and study management
• Train study site personnel and organize relevant Investigator related meetings
• Advise on logistical issues and protocol design
• Triage CRO and clinical site questions to Medical Monitor and other Project team members as appropriate
• Oversee the data clarification process as needed and ensure database lock according to agreed timelines
• Coordinate the preparation and updates of clinical protocols, and patient informed consent documents (ICFs)
• Assist in the preparation of regulatory documents including IDEs, IDE annual updates, PMAs, and regulatory meeting briefing documents where applicable
• Contribute operational input for clinical study report writing and clinical study report review
• Develop and update in-house SOPs, guidelines, and systems to ensure they appropriately describe current company procedures, and are compliant with relevant laws/guidelines
• Assure that all clinical trials are conducted in full compliance with applicable GCPs
• Approve GCP documents
• Develop work proposals, select and oversee CROs and laboratory vendors
• Develop contract terms and negotiate clinical contracts with oversight from Legal
• Develop and manage clinical trial budget, including Contract Research Organizations, clinical site budgets and external project spending to ensure adherence to the budget
• Provide senior management with necessary updates on progress and changes in scope, schedule, and resource needs in a timely manner
• Other duties as assigned by Supervisor

Preferred Qualifications

• Broad clinical development experience including Phase II, Phase III, and regulatory filings (IDEs, PMAs, INDs, NDAs, etc.)
• Previous experience working with an electronic data capture system
• International clinical development experience

Benefits

• Excellent full time benefits including comprehensive medical coverage, dental, and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays
• Salary Range: $120K - $185K