Minimum of BA/BS with 12+ years in global clinical trials, including 6+ years in high complexity trial management; advanced degree preferred.
Experience in cardiovascular or rare disease studies is preferred.
Robust background in early and late phase drug development; late-stage experience required.
Ability to devise operational plans for challenges like site activation and subject enrollment.
Proficient in cross-collaboration with various therapeutic areas and functions, demonstrating effective leadership in multi-disciplinary teams.
Experience with ICH/GCP inspections and audit preparedness.
Outstanding verbal and written communication skills.
Responsibilities
Accountable for clinical program budget, timelines, and resource management, focusing on quality and operational strategies.
Develop and present operational strategies and plans to execute the Clinical Development Plan.
Collaborate with cross-functional stakeholders including Project Team Leaders and Clinical Development Leads.
Lead execution of trials from first-in-human to phase 4, ensuring compliance with regulations and SOPs.
Drive selection and management of CROs and vendors, overseeing site feasibility assessments.
Innovate strategies for digital patient data capture and novel clinical research platforms.
Represent Clinical Operations on project teams and ensure compliance with operational standards.
Benefits
Collaborative work environment with cross-functional teams.
Opportunity to lead innovative clinical research initiatives.
Mentorship and career development opportunities for team members.
Engagement with key opinion leaders and external stakeholders.
Focus on continuous improvement in clinical development processes.
Full Job Description
Position Title: Sr. Director Clinical Operations Program Lead
Department: Development
Reports To: Head of Clinical Development
Location: Princeton, New Jersey - 4 days on site (Mon-Thur)
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 crossfunctional 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.
Exact Compensation may vary based on skills, experience and location.
