Director Global Clinical Operations

At Recor Medical, we are pioneering Ultrasound Renal Denervation (uRDN) therapy to treat hypertension, the leading cardiovascular risk factor in the world. With our Paradise™ uRDN System, we’re on a mission to provide the millions of people who suffer from hypertension with a non-drug and minimally invasive option to lower their blood pressure. Join us on our journey and make a meaningful impact on the lives of people around the globe.

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 challenges

• Oversee planning, execution, and completion of clinical trials from protocol development through final clinical study report

• Establish and implement standardized clinical processes and tools to enhance operational efficiency

• Manage clinical budget planning, forecasting, and resource allocation to optimize program performance

Cross-Functional Collaboration

• Interact with senior management, executives, and major clinical stakeholders which frequently involves negotiating matters of significance

• Reconcile multiple stakeholder views to drive clinical study results and organizational objectives

• Collaborate with Regulatory and Quality Affairs, Medical Affairs, and Scientific Affairs to ensure integrated approaches

• Partner with Research & Development and new business development to align clinical evidence generation with product development activities

• Support Marketing and Commercial teams with clinical evidence communication strategies

Scientific & 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 generation

• Engage with key opinion leaders and clinical investigators to foster strong research partnerships

• Represent Recor Medical in interactions with regulatory authorities and at scientific conferences

• Guide development of high-impact clinical publications and presentations

Requirements

• Minimum of Bachelor’s degree in life sciences or related field required; advanced degree (Master’s 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 completion

• Experience with cardiovascular medical devices; hypertension and/or renal denervation experience preferred

• Comprehensive understanding of global regulatory requirements (FDA, BSI, etc.) and clinical evidence standards

• Strong knowledge of clinical research methodologies, biostatistics, and GCP/ISO 14155 standards

• Excellent leadership abilities with demonstrated success in building and developing high-performing teams

• Strategic thinker with the ability to translate business objectives into actionable clinical plans

• Outstanding communication skills with the ability to effectively negotiate matters of significance

• Experience with global clinical operations, site management, and clinical data management

Salary range: $228,000 to $250,000 (Annual Base Salary)

The successful candidate's starting base pay will be determined based on job-related skills, experience, qualifications, work location and market conditions. The expected base pay range for this role may be modified based on market conditions. 

Equal Employment Opportunity
At Recor Medical, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer, we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.

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