Senior Director, Clinical Operations Program Lead

Position Title: Sr. Director Clinical Operations Program Lead

Department: Development

Reports To: Head of Clinical Operations

Location: Princeton, New Jersey

Job Overview

Kardigan is seeking a Senior Director, Clinical Operations Program Lead for a late-stage cardiovascular asset. This position will be responsible for leading all of the activities associated with the clinical studies for the asset across all phases, including overseeing the internal operations team, CROs and vendors and working cross-functionally on the operational strategy and related initiatives. This position reports to the Head of Development Operations and serves as a member of the Development Operations Leadership team. This position will work collaboratively across the department, the entire Kardigan portfolio and cross-functional core/project teams with the overall goal of developing new and innovative treatments for cardiovascular diseases with unmet need.

Essential Duties and Responsibilities:

• 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

Qualifications and Preferred Skills

• 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.