Sr Director of Clinical Operations

Kali Therapeutics embodies transformation and renewal, inspired by the Hindu goddess Kali, symbolizing power and rebirth. Focused on groundbreaking advancements in immunotherapy, Kali Therapeutics specializes in T-cell engagers and other innovative therapies that address high unmet medical needs. About The Role As the Sr Director, Clinical Operations, you will oversee the strategic and operational execution of clinical trials, lead cross-functional teams and collaborate with internal stakeholders and external vendors. You will manage trial budgets, vendor selection, and risk mitigation while contributing technical input to key clinical documents. You will play a critical role in the planning, implementation, management, and delivery of early phase clinical trials, ensuring studies are executed with quality, speed, and operational excellence. To succeed in this role, you must be a highly collaborative and solutions-oriented leader who thrives in a fast-moving biotech environment and enjoys building scalable operational processes while remaining close to execution. What You’ll Do Perform role of Clinical Operations trial lead for assigned trials and leads cross-functional Study Execution Teams Develop and execute trial operational strategies and partner cross-functionally to drive trial execution forward; provides strategic and technical recommendations to senior leadership Direct the selection of CROs and other vendors (IxRS, Central Lab, ancillary/tech vendors), direct development of vendor Scopes of Work (SOW), scope changes, budgets, and vendor payments and partner with CROs and other vendors to deliver on study execution Create and track clinical trial budgets Direct risk mitigation, escalation, and resolution activities both internally and with sites and vendors Direct technical and strategic input into the development of clinical documents (protocols, monitoring plans, informed consent forms, investigator brochures, clinical study reports) Build relationships with clinical sites, vendors, and key stakeholders and maintain an understanding of the external landscape to adjust plans accordingly Represent Clinical Operations in cross-functional activities and supports development and management of the Clinical Operations function Flexible and creative in meeting the needs and challenges of a growing, dynamic company and demonstrates excellent problem-solving abilities Strong financial acumen with outstanding track record of building budgets and managing expenses to budget What You’ll Bring Bachelor’s degree or equivalent in a science or health-related field; advanced degree (MS, PhD, PharmD, or MD) strongly preferred. 10+ years of clinical research experience, including 7+ years of trial management within a biopharmaceutical company; 5+ years within a small/startup company is a plus Exceptional clinical trial management skills with a focus on strategic oversight of trial execution on time and on budget, study coordinator and/or site monitoring experience a plus Extensive phase 1 through phase 3, global trial management experience Immunology and/or hematology trial management experience Extensive experience selecting and managing vendors, including CROs, labs, IxRS, EDC, and ancillary technology/applications (e.g. eDiaries, eConsent, apps, etc) Thorough knowledge and understanding of FDA and ICH Guidelines, GCP, medical terminology, and clinical trials Detailed understanding of all aspects of clinical protocol design, implementation, IND/BLA/NDA submissions, and overall drug development Experience managing, coaching, and mentoring personnel Excellent communication, organizational, negotiation, and interpersonal skills with a strong reputation for collaboration Kali is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. At Kali we engage in equitable workplace strategies to ensure fair compensation. Actual compensation is dependent upon current market data, experience, and pay parity within our organization. We take care of our employees with a competitive benefits package that provides medical, dental, and vision coverage for employees and their dependents, as well as 401(k) plans. #J-18808-Ljbffr Kali Therapeutics