Director/ Sr. Director of Global Clinical Operations
Gliknik is seeking a Director / Senior Director to be accountable for managing the overall execution of clinical trials for the portfolio of Gliknik phase 1 compounds progressing into phase 2.
Duties And Responsibilities
- Implement and manage fully outsourced clinical development
- Guide selection of and manage CROs, other vendors, and external contractors
- Lead budget negotiations and change order process
- Review contract language critically
- Participate with vendors in medical writing to draft Clinical Protocols, Investigator Brochures, Informed Consents, blinding plan, safety updates and correspondence with Regulatory Authorities through to availability of the Clinical Study Report and applicable disclosure of the trial results
- Ensure all clinical programs are conducted in accordance with their respective study protocols, ICH GCP, and other applicable regulations
- Be the primary liaison with the Qualified Person and the QP process
- Supervise third party site start-up and patient enrollment, clinical monitoring, laboratory monitoring, compliance and data from CROs and central labs
- Ensure that timelines are met on time and on budget
- Reconcile invoices to completed activities
- Maintain accurate information for reports on clinical trial status (including enrollment, timelines, analysis of the study status and identification of potential risks), Clinical Trial material (CTM) and provide such information for management budgeting
- Proactively identify project risks and develop mitigation measures
- Provide Clinical Operations expertise in cross-functional external meetings and works closely with cross functional members to ensure the quality and in accordance with ICH guidelines
Personality
- Seeks to take on additional responsibilities in a small company with a fast paced environment
- Possesses excellent organizational and time management skills and ability to work independently
- Interest in and ability to lead all aspects of execution of a clinical trial
Education And Experience
- Minimum of seven years progressive experience in pharma/biopharma/CRO clinical operations
- Strong understanding of FDA/ICH guidelines and processes
- Advanced or bachelor’s degree in medical / life science, regulatory science, or related field preferred
- Experience with biologics is preferred; experience with immunology is desirable
Competitive benefits including health insurance, Health Reimbursement Account, Flexible Spending Accounts for medical expenses and dependent care expenses, SIMPLE IRA match, and subsidized parking.
Position based in Baltimore / Washington metro, in-office or hybrid, with minimal travel expected.