Director Clinical Trials Programs Transplant Remote
Director Clinical Trials Programs Transplant Remote
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Salary Not Disclosed
1 Vacancy
Job Description
Eurofins Transplant Genomics Inc. (ETG) is a molecular diagnostics company committed to improving organ transplant outcomes with noninvasive serial monitoring guided by biomarkers. ETGs product portfolio of both individual and combined whole blood gene expression and donor derived cellfree 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 bloodbased 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 codevelopment 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 closeout.
- 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 inhouse 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
Qualifications :
- 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 multifunctional 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.
- Selfmotivated 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).
Additional Information :
Compensation:
- Salary Range: $120K $185K
Schedule:
- MondayFriday 8:00am5:00pm 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.
Remote Work :
Yes
Employment Type :
Fulltime
Employment Type
Remote
