Position Summary
The Director, Global Clinical Operations participates with senior management to establish strategic clinical plans and objectives for Recor Medical's global clinical program. The leader in collaboration with the VP, Global Clinical Affairs makes final decisions on clinical trial implementation and ensures operational effectiveness of clinical studies supporting the Paradise uRDN System. The Director is responsible for implementing and executing the functional clinical operational strategy while also contributing to development of organizational clinical policies and being accountable for actions that are impactful across multiple departments. Working on complex issues where solutions may not be clearly defined, this role supports the execution of the business strategy functional plans and guides execution of study activities that drive the generation of clinical evidence.
Responsibilities and Duties
Strategic Planning & Implementation
- Participate with senior management to establish strategic clinical plans and objectives aligned with corporate goals
- Initiate proposed decisions on clinical trial implementation and ensure operational effectiveness across global studies
- Support the implementation of key business segment strategy into functional clinical plans and guide execution across regions
- Contribute to development of organizational clinical policies that support regulatory submissions and commercial objectives
- Ensure clinical budgets and schedules meet corporate requirements and optimize resource utilization
Clinical Operations Leadership
Lead the Clinical Affairs department by providing directions to managers and team leaders who oversee daily operations and staff.Lead team(s) to develop new clinical methods and solve complex clinical trial challengesOversee planning, execution, and completion of clinical trials from protocol development through final clinical study reportEstablish and implement standardized clinical processes and tools to enhance operational efficiencyManage clinical budget planning, forecasting, and resource allocation to optimize program performanceCross-Functional Collaboration
Interact with senior management, executives, and major clinical stakeholders which frequently involves negotiating matters of significanceReconcile multiple stakeholder views to drive clinical study results and organizational objectivesCollaborate with Regulatory and Quality Affairs, Medical Affairs, and Scientific Affairs to ensure integrated approachesPartner with Research & Development and new business development to align clinical evidence generation with product development activitiesSupport Marketing and Commercial teams with clinical evidence communication strategiesScientific & Medical Engagement
Develop creative solutions when faced with new challenges where there aren't clear precedents or guidelines to follow.Participate in corporate development of methods and techniques for clinical evidence generationEngage with key opinion leaders and clinical investigators to foster strong research partnershipsRepresent Recor Medical in interactions with regulatory authorities and at scientific conferencesGuide development of high-impact clinical publications and presentationsRequirements
Minimum of Bachelors degree in life sciences or related field required; advanced degree (Masters or above) preferred.Minimum of 10+ years of clinical affairs experience in the medical device, biotech, or pharmaceutical field, with at least 5 years in a leadership role.Proven track record of successfully leading global clinical trials from conception through completionExperience with cardiovascular medical devices; hypertension and / or renal denervation experience preferredComprehensive understanding of global regulatory requirements (FDA, BSI, etc.) and clinical evidence standardsStrong knowledge of clinical research methodologies, biostatistics, and GCP / ISO 14155 standardsExcellent leadership abilities with demonstrated success in building and developing high-performing teamsStrategic thinker with the ability to translate business objectives into actionable clinical plansOutstanding communication skills with the ability to effectively negotiate matters of significanceExperience with global clinical operations, site management, and clinical data managementSalary range : $228,000 to $240,000 (Annual Base Salary)