Sr Director Clinical Affairs EMEA
vor 3 Wochen
Company Description
At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints.
As pioneer and leading company in the field of robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare’s hardest challenges and advance what is possible.
Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere—we strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves.
Passionate people who want to make a difference drive our culture—our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real-world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential.
Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let’s advance the world of minimally invasive care.
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 (, SOP’s) and regulatory requirements (, GCP and MDR, MDD& MEDDEV, guidelines) and any other laws GDPR or guidance 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.
Qualifications
Required Knowledge, Skills, and Experience:
BS or MS or PhD in Life Sciences with a preference for MD equivalent with 15- 20 years of experience in clinical affairs/research project management is preferred and at least 8 years of management experience preferred. Core competencies of this position include knowledge and understanding of clinical specialties and technology platforms; significant experience and proven success leading multiple teams in the medical device or related industry; significant experience leading clinical affairs strategies and objectives; ability to create departmental vision, strategy and strategic objectives and guide teams in their execution; establish effective programs, guidelines and procedures for global clinical affairs activities. Independently develop budget and other resource plans for larger teams and/or projects; direct the work of multiple teams, which may involve managing subordinate managers; demonstrated effectiveness in empowering others to do their best work. 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. Possess knowledge of Good Clinical Practice and 21 CFR Part 11 and international regulations, specifically EU regulations and laws; MDR, MDD, MEDDEV guidelines, ISO 14155 requirements and GDPR. Strong understanding and background of clinical trials, study design and some formal ICH/GCP knowledge and training. Strong experience in clinical affairs program development and strategies to meet business needs and KOL selection 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. Entrepreneurial, collaborative, strategic thinker with excellent project management skills and ability to prioritize and plan. Prior experience in medical robotics, surgical devices and operating room is heavily preferred. Results-driven attitude & a resolve to win; must be self-directed with the ability to work with minimal supervision. Excellent interpersonal skills with emphasis on leadership, relationship development and influence management. Superior verbal/written communication and presentation skills, teambuilding, and interpersonal skills to work across multiple constituents. Must be able to travel up to 40-50%. Must be able to manage multiple projects across numerous surgical disciplines. Good communication and interpersonal skills with high attention to detail and organization. Intellectual depth and strength of character. Fluency in English required /language fluency in other European languages such as French and German highly preferred. Ability to establish credibility with a broad range of constituents inside and outside the company.
Additional Information
Intuitive is an Equal Employment Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.
-
Sr Director Clinical Affairs EMEA
vor 3 Wochen
Aubonne, Schweiz Intuitive Surgical VollzeitJob DescriptionPrimary 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...
-
Sr Director Clinical Affairs EMEA
Vor 6 Tagen
Aubonne VD, Waadt, Schweiz Intuitive Surgical VollzeitJob DescriptionPrimary 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...
-
Sr Director Clinical Affairs EMEA
vor 3 Wochen
Aubonne VD, Waadt, Schweiz Intuitive Surgical VollzeitJob DescriptionPrimary 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...
-
Sr Director Clinical Affairs EMEA
Vor 4 Tagen
Aubonne, Schweiz Intuitive Surgical VollzeitCompany DescriptionAt Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints.As pioneer and leading company in the field of robotic-assisted surgery, we strive to foster an inclusive and diverse...
-
Sr Director Clinical Affairs EMEA
Vor 5 Tagen
Aubonne VD, Waadt, Schweiz Intuitive Surgical VollzeitCompany DescriptionAt Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints.As pioneer and leading company in the field of robotic-assisted surgery, we strive to foster an inclusive and diverse...
-
Sr Director Clinical Affairs EMEA
Vor 6 Tagen
Aubonne VD, Waadt, Schweiz Intuitive VollzeitCompany Description At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints. As pioneer and leading company in the field of robotic-assisted surgery, we strive to foster an inclusive and...
-
Sr. Manager Emea Facility Maintenance
vor 1 Woche
Aubonne, Schweiz Intuitive Vollzeit**Company Description**: At Intuitive, we are united behind our mission: we believe that mínimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints. As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse...
-
Associate Director, Cmc Regulatory Compliance
vor 3 Wochen
Aubonne, Schweiz Merck KGaA VollzeitWork Your Magic with us! Ready to explore, break barriers, and discover more? We know you’ve got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich...
-
Associate Director, Cmc Regulatory Compliance
vor 3 Wochen
Aubonne, Schweiz Merck KGaA VollzeitWork Your Magic with us! Ready to explore, break barriers, and discover more? We know you’ve got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich...
-
Regulatory Affairs Lead
vor 4 Wochen
Aubonne, Schweiz Intuitive VollzeitCompany Description At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints. As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse...
-
Regulatory Affairs Lead
vor 4 Wochen
Aubonne, Schweiz Intuitive Surgical VollzeitCompany DescriptionAt Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints. As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team,...
-
Regulatory Affairs Coordinator
vor 4 Wochen
Aubonne, Schweiz Intuitive VollzeitCompany Description At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints. As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse...
-
Regulatory Affairs Coordinator
vor 4 Wochen
Aubonne, Schweiz Intuitive Surgical VollzeitCompany DescriptionAt Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints. As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team,...
-
Associate Director, Cmc Regulatory Compliance
Vor 5 Tagen
Aubonne VD, Waadt, Schweiz Merck KGaA VollzeitWork Your Magic with usReady to explore, break barriers, and discover more? We know you've got big plans - so do we Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of...
-
Global Regulatory Affair Cmc Intelligence
vor 2 Monaten
Aubonne, Schweiz Merck KGaA Darmstadt Germany VollzeitWork Your Magic with us! Ready to explore, break barriers, and discover more? We know you've got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of...
-
Sr. Counsel, Privacy Data Protection
vor 4 Wochen
Aubonne, Schweiz Intuitive Surgical VollzeitJob DescriptionPrimary Function of Position:Intuitive is looking for an experienced privacy professional to join our data protection team. Reporting to the lead EMEA privacy and data protection counsel, this position will assist with supporting teams in Europe and globally throughout the enterprise and help shape the development of new and innovative...
-
Global Regulatory Affair Cmc Intelligence
Vor 6 Tagen
Aubonne VD, Waadt, Schweiz Merck KGaA Darmstadt Germany VollzeitWork Your Magic with usReady to explore, break barriers, and discover more? We know you've got big plans - so do we Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of...
-
Sr. Counsel, Privacy Data Protection
Vor 5 Tagen
Aubonne VD, Waadt, Schweiz Intuitive Surgical VollzeitJob DescriptionPrimary Function of Position:Intuitive is looking for an experienced privacy professional to join our data protection team. Reporting to the lead EMEA privacy and data protection counsel, this position will assist with supporting teams in Europe and globally throughout the enterprise and help shape the development of new and innovative...
-
Sr. Counsel, Privacy Data Protection
vor 4 Wochen
Aubonne VD, Waadt, Schweiz Intuitive Surgical VollzeitJob DescriptionPrimary Function of Position:Intuitive is looking for an experienced privacy professional to join our data protection team. Reporting to the lead EMEA privacy and data protection counsel, this position will assist with supporting teams in Europe and globally throughout the enterprise and help shape the development of new and innovative...
-
Sr. Counsel, Privacy Data Protection
vor 3 Wochen
aubonne, Schweiz Intuitive Surgical VollzeitCompany DescriptionAt Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints.As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team,...
