Sr Director Clinical Affairs EMEA

vor 3 Wochen

Aubonne VD, Waadt, Schweiz Intuitive Surgical Vollzeit
Job Description

Primary Function of Position:

The Senior Director, Clinical Affairs EMEA reports to the Vice President, Global Clinical Affairs. The purpose of this role is to guide, develop and execute long range clinical trial strategies, inclusive of first human use, regulatory driven studies (pre- market and PMCF studies ) and post-market evidence generation across multiple platforms and emerging technologies . This role will provide strategic guidance and oversight for clinical evidence strategies that meet regional and global needs. Additionally, this role will influence and shape the decision making, resolve the most complex issues facing the organization for enablement of regional vision developed the regional GM and Medical Office; by contributing to innovative concepts and promoting new ideas for evidence creation. by significant collaboration with key EMEA functions and representatives from various business units for priority and process alignment.

This position is based in Europe, Intuitive Surgical office, with direct reporting to Intuitive Surgical HQ in Sunnyvale, CA, USA, Clinical Affairs Department.

Roles and Responsibilities:

  • Play a lead role in the development of the company's clinical and scientific strategies, including clinical studies for new product development (first human use), post-market evidence generation including various innovative RWE (Real world evidence) approaches or emerging markets generation across multiple platforms and emerging technologies.
  • Highly skilled at translating strategic, corporate and technical content into clear evidence roadmap that effectively engages multiple functions. Creates key performance indicators (KPI) and 3-year evidence plans in support of strategic initiatives for regional business.
  • Responsible for providing strategic guidance to global clinical evidence strategy for various platforms and indications with strong collaboration with various Business Units, Medical office, Commercial functions, MACA, GAVE representatives, RA, GPA
  • Responsible for cross functional collaboration with various key functions within the organization to shape external environment through interactions with notified body and regulatory agency and external working groups.
  • Drive the development and implementation of clinical research strategies to meet business goals and objectives. Responsible for setting up effective goals that are meaningful to the department and impactful to the organization.
  • Responsible and accountable for year over year program budgets related to clinical affairs EMEA activities.
  • Consistently works with abstract ideas or situations across functional areas of the business. Through assessment of intangible variables, identifies and evaluates fundamental issues, providing strategy and direction for major functional areas.
  • Proactively plans for future organization growth and success.
  • Demonstrates advanced leadership skills by effectively managing the most complex communications facing the organization - in times of significant change, in the face of setback, in positioning ISI as an industry leader, and in mobilizing large, cross-functional teams to achieve strategic goals and objectives. Develops advanced communication skills in other leaders.
  • Interacts internally and externally with executive level management, requiring negotiation of extremely critical matters. Influences policymaking and strategic decisions within the organization as a whole.
  • Monitors changes in EU regulations, laws, clinical trial guidance or National strategies pertaining to evidence generation in region to consult internally on best regional evidence practice.
  • Ensures compliance with corporate (e.g., SOP's) and regulatory requirements (e.g., GCP and MDR, MDD& MEDDEV, guidelines) and any other laws e.g. GDPR or guidance e.g. MEDTECH, pertaining to industry research in region.
  • Responsible for PRRC activities pertaining to clinical affairs activities.
  • Provides solutions and efficiencies for departmental process improvements and standard operating procedures.
  • Provide leadership and direction to the broader Clinical Affairs team. Addresses current and future opportunities and issues to ensure sustainable success.
  • Influences and shapes decision-making at the highest organizational levels, internally and externally. Provides significant strategic contributions that positively influence the strategic direction of multiple ISI functions and teams. Resolves the most complex issues facing the business; typically issues directly or indirectly affecting ISI's growth, ability to compete, financial results, industry leadership position, etc.
  • Interact internally and externally with executive level management, requiring negotiation of extremely critical matters. Influences policymaking and strategic decisions within the organization as a whole.
  • As a functional manager, this role is responsible for effectively hiring and developing the European clinical affairs function, 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 good team spirit.

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