Director of Critical Care Devices, GMO

Fresenius Medical Care•Kennesaw, GA

1d•Remote

About The Position

Support the Fresenius Medical Care mission, vision, core values, and customer service philosophy. Adhere to the company’s compliance program, including the following regulatory and company policy requirements. Collaborate with the appropriate stakeholders to plan, develop, and execute clinical and medical affairs activities that advance the utilization of critical care device programs at the divisional Global Medical Office level, ensuring alignment with the company’s goals and objectives. Provide medical, scientific, and operational leadership to support the adoption of industry-leading knowledge across the organization.

Requirements

Medical doctor – Critical Care Medicine or Nephrology.
Board certification preferred.
8–12+ years of relevant clinical, academic, or medical device industry experience.
3+ years in a people management or program leadership role.
Demonstrated subject-matter expertise in critical care medicine, with working familiarity in extracorporeal therapies (CRRT, ECMO, hemoabsorption, or related modalities).
Strong influencing and management skills, with the ability to lead cohesive and productive multidisciplinary teams.
Strong interpersonal skills with the ability to communicate with all levels of management through diplomacy and tact.
Excellent oral and written communication skills, including scientific writing and presentation.
Strong educational background, with a track record of peer-reviewed publications or guideline contributions preferred.

Responsibilities

Translate divisional medical strategy into actionable plans and lead day-to-day execution of programs supporting the critical care device portfolio, including extracorporeal therapies for renal and cardiopulmonary support.
Support the Senior Director in the planning, development, and implementation of medical affairs initiatives, ensuring effective communication of the company’s mission and core values to drive adoption within and beyond the division.
Manage operational activities across assigned business processes and services to ensure timely, compliant, and high-quality achievement of program objectives within assigned business units.
Interpret and apply company-wide policies and procedures relevant to the assigned functional areas; oversee program-level activities and ensure alignment with divisional priorities.
Contribute to the development of departmental budgets, schedules, and resource plans; manage expense priorities and report progress to the Senior Director, consistent with the company’s planning, staffing, and budgeting requirements.
Review and comply with the Code of Business Conduct and all applicable company policies and procedures as well as local, state, and federal laws and regulations.
Ensure all employees within the assigned team understand and comply with the Code of Business Conduct and all applicable company policies and procedures as well as local, state, and federal laws and regulations; maintain effective internal systems and controls to promote compliance.
Apply broad-based knowledge of the medical device industry, critical care medicine, and extracorporeal therapies to deliver tactical solutions within the assigned functional area.
Exercise decision-making authority on operational and program-level matters, with input from the Senior Director on issues of broader organizational impact.
Develop and implement annual operating plans and tactical objectives for assigned programs, aligned with divisional and corporate strategy.
Participate in developing business unit strategies and supporting resource allocation decisions to ensure objectives are achieved.
Establish protocols to facilitate interdepartmental coordination, including routine collaboration mechanisms and escalation pathways for unanticipated events.
Make decisions of moderate to significant complexity with budgetary and team management responsibilities. Decisions are typically evaluated against program-level outcomes and divisional objectives, with material impact on the success of assigned programs.
Oversee focused operations within a defined program area or product line, with direct responsibility for one or more cross-functional teams.
Interact regularly with internal stakeholders across Medical Affairs, R&D, Regulatory, Clinical Operations, and Commercial.
Engage with senior leadership, including value stream leaders, on matters relevant to the assigned portfolio.
Serve as a medical and scientific representative of the organization to external customers, key opinion leaders, clinical investigators, and academic centers.
Represent the company at scientific congresses, advisory boards, and expert forums, including activities aimed at regulators and professional societies.
Provide medical and technical guidance to internal teams, including Medical Science Liaisons, Clinical Specialists, and field-facing personnel.
Support pre-launch and launch activities for new critical care device technologies expected within a two-year horizon.
Lead the development of clinical education content for physicians, healthcare providers, and internal employees, with particular focus on critical care medicine.
Maintain working knowledge of the science of extracorporeal membrane oxygenation and gas exchange and apply it across program activities.
Maintain working knowledge of renal replacement therapy in the intensive care unit, including CRRT modalities, anticoagulation strategies, and adequacy of dosing.
Contribute to the development and ongoing maintenance of a library of measures within Fresenius Medical Care to support the assessment of clinical performance across critical care programs.
Develop and maintain relationships with key opinion leaders in Critical Care and Nephrology; support the planning and execution of advisory board activities.
Lead clinical research projects and publication strategies to support regulatory activities and post-market evidence generation on existing and new devices or technology.
Participate in all Fresenius Medical Care Global Medical Office and Medical Affairs activities as required.
Other duties as assigned. Additional responsibilities may include a focus on one or more departments or locations. See applicable addendum for department or location-specific functions.