Recor Medical
Director, Global Clinical Operations
Recor Medical, Palo Alto, California, United States, 94306
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Director, Clinical Affairs
role at
Recor Medical
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, Clinical Affairs 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.
Respecting your privacy is an essential part of the Company’s privacy program and we are committed to the proper handling of Personal Information collected or processed in connection with an Applicant’s application for employment, a Contract Worker’s work, or a Former Employee’s employment at Recor. Refer to our Applicant, Contract Worker & Former Employee Privacy Policy for more detail information.
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Director, Clinical Affairs
role at
Recor Medical
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, Clinical Affairs 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.
Respecting your privacy is an essential part of the Company’s privacy program and we are committed to the proper handling of Personal Information collected or processed in connection with an Applicant’s application for employment, a Contract Worker’s work, or a Former Employee’s employment at Recor. Refer to our Applicant, Contract Worker & Former Employee Privacy Policy for more detail information.
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