Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. Eurofins is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. Eurofins is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. The Group also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products. In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to 55,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 50 countries. Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products. Eurofins Transplant Genomics Inc. (“ETG”) is a molecular diagnostics company committed to improving organ transplant outcomes with non-invasive serial monitoring guided by biomarkers. ETG’s product portfolio of both individual and combined whole blood gene expression and donor derived cell-free DNA testing is capable of reliably ruling out subclinical kidney rejection and acute rejection in kidney transplant patients. In addition to kidney transplantation testing, our newest product for liver transplant patients is a blood-based biomarker assay designed to rule out rejection as immunosuppression therapy is optimized.  Basic Function and Scope of Responsibility: The Director of Clinical Trials is responsible for the operation and oversight of the clinical studies program.  In this role the individual will lead or assist in protocol development, lead the integration of functional activities across internal project team members, clinical site staff and vendors, to ensure the completion of milestone deliverables per project timelines and budget.  This individual will be responsible for identifying key project obstacles and solutions towards achieving corporate goals.  Additionally, the Director will have direct management oversight of project specific Clinical Studies staff and is expected to directly supervisor staff, mentor staff, and foster a team environment. Responsibilities: + Responsible for development or co-development of study protocols which includes 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. + Oversight of clinical trial site management in conjunction with selected CRO, including site qualification, site initiation, monitoring oversight, source documentation, and study close-out. + Thorough training of clinical team members in the clinical trial process and study management. + Training of study site personnel and organization of 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. + Oversight of data clarification process as needed and insure 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. + Responsible for development of work proposals, selection and oversight of 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 + 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. + Broad clinical development experience preferred including Phase II, Phase III, and regulatory filings (IDEs, PMAs, INDs, NDAs, etc.). + Previous experience working with an electronic data capture system preferred + International clinical development experience is a plus. + Well versed in Good Clinical Practice required. + 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. + The position may require significant travel up to 50% (Investigator meetings, professional society meetings, leadership meetings). Compensation: + Salary Range:  $120K - $185K Schedule: + Monday-Friday 8:00am-5:00pm plus travel What we offer: + 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 Eurofins USA Clinical Diagnostics is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.