Senior Director CLinical Operations
The Senior Director of Clinical Development will be responsible for the planning, implementation, execution and management of clinical studies by overseeing day-to-day operations and directly managing outside Clinical Research Organizations.
Reporting to the Head of Clinical Operations and Compliance, this role provides the opportunity for the right candidate with the chance to truly make an impact on the lives of patients and future success at Karuna.
Roles and Responsibilities
While working closely with Head of CO&C, plans and communicates with cross-functional areas to ensure proper execution and conduct of the clinical trial; generating quality clinical data.
Serves as primary contact and resource for CRO and vendor personnel in overarching functions as well as team members in Karuna.
Provides oversight and management of CROs, consultants and vendors.
Oversees and monitors the management of clinical studies ensuring they are conducted in compliance with the agreed study plans through regular CRO and/or investigator site contact.
Monitors progress of clinical activity and reports on the progress of assigned clinical trials including budget and timelines.
Monitors the status of clinical data collection of assigned clinical trials.
Prepares potential investigator site lists and assists with their evaluation for inclusion in the study.
Prepares and reviews study-related documents as required.
Reviews and approves study-related plans generated by CROs and vendors, and ensures the documentation is in accordance with GCP regulatory requirements and consistent with the protocol for assigned studies.
Participates in the review and finalization of clinical study-related documents such as protocols, protocol amendments, clinical study reports (CSRs), regulatory submissions and other publications as required.
Participates in meetings – i.e. Study Team Meetings, Investigator Meetings, Monitors’ workshops and CRO Training.
Reviews correspondences and monitoring reports relating to the studies.
Prepare and deliver program/study updates.
Coordinates the delivery of clinical trial supplies in collaboration with CRO and other Karuna team members.
Monitors budget for clinical study, and reviews budgets and contracts with CROs, vendors and investigator sites (as applicable) in collaboration with Finance and Legal team members.
Requests and critically evaluates proposals and change orders from CROs, vendors and investigator sites (as applicable).
Provides input into contracts, work orders and/or change orders.
Manages escalation of study related issues and communicates as appropriate with management and other R&D functions.
Ability to anticipate potential study issues and to prepare contingency plans with minimal oversight.
Ensures assigned studies adhere to all applicable regulations and requirements.
Provides input as the subject matter expert for the assigned studies during regulatory inspections.
Establish collaborative and productive relationships with internal/external partners
Evaluates issues found in clinical studies, communication and oversight of CROs and vendors, and suggests and implements solutions and mitigations as required.
Evaluate CRO and vendor performance and support the improvement initiatives.
Participate in the preparation, review, updating and training of SOPs.
Maintain knowledge of neuroscience therapeutic area, current medical practice and pharmaceutical regulations in order to ensure best practice across all activities.
May mentor other team members.
Perform other duties as requested by the senior management.
Experience, Education and Specialized Knowledge and Skills
The successful candidate must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient. Ability to analyze complex issues to develop relevant and realistic plans and recommendations. Excellent written and verbal communication skills, strong problem-solving ability, and attention to detail and quality are critical to success.
Specific requirements include but are not limited to:
Requires a BA/BS preferably in nursing, biology, biochemistry, or related areas (advanced degrees desirable) with at least 10 years of experience in clinical research operations.
Experience in phase I-III clinical studies. Global experience a plus.
Understands and ensures adherence to SOPs, ICH/GCP, and FDA and other health authorities’ regulations, with strong understanding of inspection readiness.
Demonstrated knowledge and experience in the regulatory aspects of pharmaceutical development, including protocol implementation, data collection and reporting, and understands preparation of regulatory submissions
Demonstrated experience in study management/monitoring, as well as working and negotiating with CROs.
Demonstrated project management expertise, including the leadership and development of cross functional teams.
Demonstrated ability to work independently with exceptional organization and attention to detail.