Senior Director, Clinical Operations Program Lead

Qualifications and Preferred Skillsnice to have

• Minimum of BA/BS with at least 12 years of global clinical trial and clinical program experience, including 6+ years of high complexity independent, global trial management experience. Advanced degree preferred.
• Experience within the field of cardiovascular or rare disease studies is preferred.
• Robust experience in early and late phase drug development; some late-stage development experience is required.
• Multi-dimensional Clinical Operations background with capability of devising plans for operational challenges such as site activation, subject enrollment, monitoring oversight, protocol deviation management, data cleaning, etc.
• Cross-Collaboration proficiency with other therapeutic areas and functions such as Regulatory, CMC, Biostatistics, Data Management, Finance, Program Management, etc.
• Proven track record of effective leadership and team-building skills in the context of a multi-disciplinary team in the biotech or pharmaceutical industry
• Experience in ICH/GCP inspections, audits and inspection preparedness
• Outstanding communication skills, both verbal and written
• Excellent organizational skills and ability to work independently
• Confidence to challenging status-quo thinking and behavior; can work with agility and an innovative mindset.

• Accountable for the delivery of the assigned clinical program’s budget, timelines, and resource management with focus on quality, including making recommendations and decisions regarding operational strategies to support study and/or program objectives
• Develop and present the operational strategy and plans including supply chain to effectively execute on the Clinical Development Plan
• Partner and collaborate with cross-functional stakeholders such as the Project Team Leader, Clinical Development Lead, Regulatory Lead, and other relevant stakeholders
• Lead and oversee execution of first-in-human through phase 4 trials, depending on lifecycle of program, in compliance with ICH/GCP, local regulations, and Kardigan’s SOPs
• Drive the selection, oversight, and management of CROs and other vendors
• Oversee site feasibility/capability assessments in collaboration with the CRO and cross-functional team
• Own the strategy and execution of creative approaches to achieve Kardigan’s corporate goals. This may include innovative solutions to digital patient-oriented data capture and storage, the development and deployment of novel clinical research platforms and approaches, and the pursuit of collaborations that will enhance progress of Kardigan’s research programs
• Review and provide clinical operations input into relevant clinical documents such as the protocol, investigator brochure, regulatory documents, clinical study reports and other documents and plans as appropriate
• Lead and provide oversight to the trial-specific operations team including the CROs/vendor(s) to function effectively and cohesively
• Responsible for representing Clinical Operations on cross-functional project teams and vendor/CRO operational meetings and ensuring compliance with operational standards and procedures.
• Along with other Clinical Development personnel, represent Kardigan’s externally to Investigators, site staff, and Key Opinion Leaders
• Perform and document study level Sponsor Oversight of outsourced clinical activities
• Communicate study-status, cost and issues to ensure timely decision-making by senior management
• Oversee/collaborate on and contribute to inspection readiness activities that support audits and regulatory inspections related to clinical trial conduct
• Maintain oversight and participate in the creation/review/training/maintenance of departmental and organizational SOPs to ensure compliance
• Lead and/or participate in Development Operations workstreams related to departmental and operating model related initiatives
• Develop and foster strong, collaborative relationships with key stakeholders both within and external to Kardigan’s, including Prolaio
• Directly manage assigned Clinical Trial Leads with a focus on performance, coaching and career development; provide mentorship to Site Operations Managers/Associates by providing clinical operations expertise and support identification and prioritization of study and program level work.
• Strive for continuous improvement and more efficient ways of working in clinical development