Reporting to the VP of Clinical, Regulatory and Quality Affairs, the Director is responsible for clinical affairs planning and execution according to company objectives. This position will work closely with the Clinical Research team and the Market/Clinical Development division and collaborate closely with team members across the company to achieve clinical research objectives and regulatory compliance/approvals inside and outside of the US.  The core responsibilities include overseeing clinical activities including the planning and resource needs, along with directing the various regulatory requirements associated with clinical research in the US and outside the US.  This will include an emphasis on US IDE study requirements, directing and executing on both the operational strategy and regulatory requirements. This individual must possess exceptional communication skills (oral and written) and a passion for problem solving. The work environment requires the candidate to function as both a leader and a team member, splitting time between the operational planning/management and the operational execution and task-based deliverables.  This individual will work collaboratively with colleagues and staff to create a results-driven team-oriented environment.

 

Responsibilities

    • Ensure duties and responsibilities are conducted in compliance to applicable regulations, standards, the company quality system, and company policies and procedures. 
    • Collaboratively work with cross functional teams to enable successful product launches for both pre-clinical, clinical and commercialization phases.
    • Establishes and evolves operating policies and procedures to manage clinical research efficiently and effectively.   
    • Direct leadership and management of clinical research infrastructure, including development of clinical research protocols, case report forms, informed consent forms, and management of trial master files, in conjunction with the clinical research team.
    • Direct leadership and management of clinical research workflows, including data collection, data management, data analysis, and data reports, in conjunction with the clinical research team.
    • Directly or indirectly supervise clinical research staff, including consultants and third parties. Builds strong, trusting, and cooperative relationships with others across multiple projects.
    • Direct the operational aspects of company sponsored (and related) clinical research and regularly reports on progress and status including initiating and leading team meetings.
    • Direct the development of clinical research strategy, timelines, milestones, project plans/deliverables, budget and resource allocations.
    • Responsible for obtaining and maintaining regulatory approvals and compliance in accordance with the strategic objectives of the company and in compliance with applicable policies, procedures, standards, and regulations.  
    • Responsible for representing the company with key opinion leaders, principal investigators, and regulatory agencies including US FDA and similar entities outside the US.
    • Develops strategies for efficient study conduct, data collection, subject management and safety monitoring.
    • Leads and supports interactions with regulatory agencies, including but not limited to US FDA, EU notified body and competent authorities, and other international agencies.
    • Identifies risk, opportunities, and solutions, and proactively informs department management.
    • Maintains confidentiality regarding company related matters.
    • Assist with the development and adherence to the department budget.
    • Regular travel for business objectives is required, including international.
    • Daily phone calls and interactive meetings (Zoom, Teams, Skype, Facetime) will be required on a regular basis.
    • Duties may require standing, walking, and/or sitting for extended portions of the workday; able to lift and carry 25 pounds.


Experience

    • 10+ years of clinical research experience, cardiovascular medical device clinical research preferred.
    • 7+ years of medical device clinical research experience in the USA, including IDE and post-market.
    • 7+ years of medical device clinical research experience outside the USA. Pre- and post-market experience preferred.
    • Demonstrated understanding of FDA regulations, ISO-13485, ISO-9001, GMPs, and related regulations pertaining to EU, Canada, Australia, New Zealand, and other markets outside the US.
    • Experience in multiple start-up companies is preferred.
    • Class II and III medical device experience is required.
    • Experience directing and managing USA FDA submissions – IDE, PMA, 510(k), De Novo.
    • Experience directing clinical research in the EU, Canada, Australia, New Zealand, and other regions outside the US.
    • Experience managing clinical research reporting, such as reporting to regulatory authorities and clinical research oversight entities (IRB/Ethics).
    • Demonstrated ability to function as both a project leader and a project team member.
    • Demonstrated ability to solve complex clinical research challenges, including both technical/scientific challenges and operational challenges.
    • Demonstrated ability to build trusting collaborative relationships with research site staff and third parties (ex. CRO, Core Labs)
    • Demonstrated ability to identify priorities for self and team and advise on how to shift priorities and competing demands.
    • Demonstrated ability to effectively communicate, collaborate and influence across all levels of the company and all levels of a clinical research project.
    • Demonstrated ability to create clinical operations infrastructure, including policies, procedures, study documentation (protocol, forms), and workflows.
    • Extensive knowledge of clinical study operations, study design and governing regulations.
    • Extensive knowledge of SOPs, GCPs, global regulations and compliance guidelines for clinical trials.
    • Extensive knowledge of the clinical study regulatory process, including ethics/IRB and interactions with various regulatory agencies inside and outside the US.
    • Experience with software tools for clinical research including electronic data capture and electronic database development and utilization.
    • Clinical research budget management experience.
    • Project management experience and fluency with related tools.
    • Proficient knowledge of medical terminology including cardiovascular medical device and cardiovascular pathophysiology.
    • Demonstrated ability to interact with key opinion leaders, principal investigators, and regulatory agencies.
    • Demonstrated ability to successfully manage multiple tasks and timelines in a fast-paced environment, bearing high levels of responsibility and accountability while keeping the best interests of the business in sight.
    • Demonstrated ability to evaluate information quickly, identify key issues, and formulate conclusions based on sound, practical judgement, experience, and common sense.
    • Demonstrated ability to be well-organized, a self-starter, and able to function with minimal supervision.
    • Detailed oriented, with an analytical approach to problem solving and decision making.
    • Proficient knowledge and demonstrated ability using MS Office Suite. 


Education

Bachelor’s degree in a medical or related field and/or an advanced degree in a related field preferred, but not required.

 

Location

This position allows for remote-based employment, or employment based in the Alleviant Medical office (Austin, Texas, USA).  If remote-based, the candidate must maintain a suitable work environment (i.e., home office).  Home office supplies and equipment will be allocated and/or reimbursed, following employment agreement and agreement with the hiring manager.  Domestic and international travel, as needed (~25-50% minimum.)

 

 

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