Director Clinical Affairs

Job description

Primary Function of Position

This role is responsible for developing and executing short-term and long-range clinical study strategies and plans to support premarket and postmarket clinical evidence needs for assigned Intuitive products and European markets. As a key cross-functional constituent, this employee will work in a global matrix with functions across the organization/Region – BU/country GMs and Marketing, Medical Affairs, Market Access, Regulatory Affairs, Global Public Affairs to optimize clinical evidence strategies to meet business objectives.

This position will be responsible for leading teams to develop and coordinate various strategic and tactical clinical evidence generation and dissemination activities, including the development of outcomes research studies, manuscripts, registries, collaborative studies, scientific evidence generation with medical/surgical societies, and investigator-initiated studies.

Roles and Responsibilities

Drives the development and implementation of clinical evidence strategies to meet business goals and objectives for European markets. Responsible for effective cross-functional collaboration within a global matrix including interactions with EU Region/Country commercial leaders, Marketing, Medical Affairs, Market Access, Regulatory Affairs, Finance, Legal, Global Public Affairs to facilitate European program/project strategies.

Highly skilled at translating strategic, corporate and technical content into clear evidence roadmap that effectively engages multiple functions. Effective in providing strategic direction and establishing priorities that balance short-term and long-term business needs. Ensures the function and team consistently meets its targets, goals, and objectives, while keeping an eye on the future and how current results affect and support future needs and evolutions.

Responsible for establishing effective goals that are meaningful to the department and impactful to the organization. Oversee European clinical research activities for assigned areas of responsibility with minimal supervision including company sponsored studies, collaborative studies, investigator-initiated studies and scientific evidence generation with medical/surgical societies. Build relationships with KOLs, hospitals, medical/surgical societies to support clinical evidence planning, generation, and dissemination.

Contributes to, reviews and approves key clinical documents and plans, including but not limited to: Clinical Investigation Plans, Clinical Study Reports, and Post-Market Clinical Follow-up (PMCF) plans and reports. As a functional manager, this role is responsible for effectively hiring and developing the clinical affairs staff, while coaching and guiding the overall team members in their internal/external communication and providing support to direct reports to consistently achieve their goals and objectives, while reinforcing a culture of inclusion, diversity and team spirit.

Provide leadership and direction to the broader Clinical Affairs organization as needed Ensure compliance with corporate (e.g., SOP’s) and regulatory (e.g., GCP, EU MDR, US FDA, data protection) requirements. Provides solutions and efficiencies for departmental process improvements, standard operating procedures and quality initiatives.

Qualifications

Required Knowledge, Skills, and Experience

Advanced degree such as M.D, MS or PhD in scientific/bioengineering field with 8-12 years of experience in clinical affairs/research project management is preferred and at least 4 years of people management experience. Relevant job experience combined with technical degree and/or master's degree may qualify. Previous experience assisting with the development of premarket (e.g. pre-CE mark) and/or post-market evidence generation is required Prior experience in surgical robotics and endoscopic surgery is highly preferred.

Possesses strong working knowledge of Good Clinical Practice, ISO 14155, EU MDR regulations and other international regulations. Strong scientific acumen and expertise in evidence appraisal and clinical research methodologies. Proven track record of leadership by example and developing high-performing teams Excellent ability to interact with physicians and other professionals inside and outside the company. Experience of successful interactions with regulatory authorities, scientific congresses and peer-reviewed journals.

Strategic thinker with excellent project management skills and ability to prioritize and plan Results-driven attitude & a resolve to win; must be self-directed with the ability to work with minimal supervision. Excellent relational skills with emphasis on leadership, relationship development, employee development and influence management. Excellent Verbal/written communication and presentation skills, teambuilding, and relational skills to work across multiple constituents.

Fluency in English required; language fluency in other European languages preferred Must be able to travel up to 30-40%, predominantly in Europe, but including outside of Europe as needed