Kenai Therapeutics

Clinical Operations

• Develop and execute clinical operations strategies to support company objectives and ensure alignment with the broader business goals.
• Collaborate with senior leadership, including the CMO, to shape and execute the clinical development strategy, ensuring it meets regulatory, scientific, and commercial needs.
• Lead the planning, design, and execution of clinical trials, ensuring adherence to timelines, budgets, regulatory standards (GCP/ICH), and quality expectations.
• Oversee the creation and execution of critical clinical documents, including study protocols, clinical study reports, investigator brochures, and safety monitoring plans.
• Develop resourcing strategies to support clinical program needs, ensuring adequate and efficient allocation of resources for both internal and outsourced activities.
• Identify, select, and manage external vendors, CROs, and other partners, ensuring high performance and adherence to project goals and timelines.
• Lead and collaborate with other functional areas, including Regulatory Affairs, Medical Affairs, Biometrics, and Research, to ensure integration of project goals and efficient execution of clinical programs.
• Serve as a key representative of Clinical Operations in interactions with external stakeholders, including KOLs, patient advocacy groups, regulatory agencies, and vendors.
• Ensure the patient voice is integrated into the planning, design, and execution of clinical trials.
• Oversee the clinical trial budgets, resource allocation, and financial forecasting, ensuring projects are delivered on time and within budget.
• Provide regular updates to executive management on the status of ongoing clinical programs and trials.
• Ensure that all clinical trials comply with applicable regulatory guidelines, including FDA, EMA, and ICH standards.
• Collaborate with the pharmacovigilance team to monitor and evaluate the safety profile of drugs under investigation, ensuring continuous safety monitoring and compliance.
• Lead, mentor, and develop a high-performing Clinical Operations team, providing coaching, training, and career development opportunities.
• Foster a culture of collaboration, quality, and excellence within Clinical Operations and across the organization.

VP, Clinical Operations