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Director/Senior Director of Clinical Operations
Durham, NC 27713 United States
Spyryx Biosciences is a clinical-stage biopharmaceutical company developing inhaled peptide therapeutics with a novel mechanism of action to enhance airway hydration and promote mucociliary clearance in severe respiratory diseases. Spyryx has completed a Series A round of funding with top-tier venture investors to advance its lead compound into clinical development for cystic fibrosis (CF) with a parallel preclinical effort in additional pulmonary indications. The Company’s lead program, SPX-101, is now in Phase 2 and when reviewed by the Clinical Trial Network of the European Cystic Fibrosis Society was awarded the highest priority rating available to them. The Phase 2 study is also being financed by the Cystic Fibrosis Foundation in the USA. The Company’s novel biology and innovative technology, combined with an exceptional team and strong financing, make this an exciting opportunity to put your fingerprints on the development of important new therapies for patients with high unmet need.
Spyryx is currently seeking a Director or Senior Director of Clinical Operations to join our R&D team. We are seeking an experienced professional with hands-on clinical research experience in a pharmaceutical or CRO environment, preferably with experience in developing respiratory therapies. This position will be responsible for the operational management and oversight of clinical trials within the clinical development program, including working closely with the Chief Medical Officer and other cross-functional representatives to ensure successful completion of all clinical activities and project deliverables within the required timeframe and budget. The level of independence and scope of responsibilities assigned may vary depending on the experience of the successful candidate.
Key functions of this position are to:
• participate in strategic clinical development planning and coordinate with senior staff on implementation of clinical programs.
• establish and maintain strong partnerships with sites and investigators, CROs, and third-party vendors, including on-site visits as applicable, overseeing performance and managing cross-collaboration with the internal Spyryx team including the Clinical Trial Manager.
• ensure compliance with study protocols and scope of work, applicable regulations, company processes, SOPs, and GCP and ICH guidelines; identify areas of concern and escalate as appropriate.
• report on clinical trial metrics including progress of study, patient enrollment, monitoring visits, and data collection.
• review study documents including protocols, amendments, study guides, case report forms, and any other clinical research related documents.
• manage RFP/bid process and perform initial review of CRO and other third-party study vendor invoices to ensure that work is performed in accordance with scope of work and agreed budget.
• demonstrate excellent presentation skills at both internal management and Board of Directors meetings as well as at external meetings.
Specific Experience and Skills of the candidate are to:
• manage industry sponsored clinical studies, minimum 5 years, with respiratory therapeutic experience preferred.
• manage clinical study vendors, including performance assessments and total financial management (invoice review, change order management, budget reforecasting, etc.).
• review and negotiate all financial aspects of clinical trials including CRO contracts and site budgets and contracts.
• exude high energy, enthusiasm, and be goal driven with demonstrated ability to handle multiple parallel programs and excellent communication skills (written and verbal).
• review and submit documents, such as clinical trial protocols, Investigator Brochures etc.
• poses in-depth knowledge of applicable regulatory requirements (e.g., GCP and ICH guidelines).
• demonstrate ability to work effectively, both alone and within a multi-functional study team.
• display proficiency with MS Word, Excel and PowerPoint.
• embrace travel domestically and internationally, frequent at times.
This position will be based at Spyryx, Durham, NC.
North Carolina Biotechnology Center