Vice President, Clinical and Scientific Affairs

Vice President Of Clinical And Scientific Affairs

Boston Scientific, Endoscopy is seeking a highly experienced and visionary Vice President of Clinical and Scientific Affairs to lead the Clinical Trials and Scientific Affairs function within Medical Affairs. The successful candidate will be responsible for working cross-functionally to help product teams generate evidence strategies for products within the Endoscopy portfolio and oversee the design, execution, and interpretation of evidence generation efforts including sponsored clinical trials, investigator sponsored research, cooperative clinical research, and the use of real-world evidence. This person will also drive evidence dissemination both internally to the Division and externally to the healthcare field. The role is globally focused with the aim of demonstrating the value of Boston Scientific, Endoscopy products in healthcare markets around the world. This role reports into the Chief Medical Officer and Vice President of Medical Affairs, Endoscopy.

Key Responsibilities:

• Lead a Clinical Trials team that works cross-functionally to understand clinical evidence requirements within the Division and designs, executes, and interprets clinical trial research in accordance with regulatory and corporate standards and consistent with BSC business and functional objectives.
• Chair the Investigator Sponsored Research & Cooperative Clinical Research Committee which reviews and approves funding for these types of research activities.
• Gather clinical evidence needs from the Endoscopy division's global regions and incorporate into a global evidence plan.
• Leverage multiple evidence generation strategies to support the value proposition of Endoscopy products including sponsored clinical trials, cooperative clinical research, investigator sponsored research, and use of real-world evidence.
• Oversee the development and submission of scientific manuscripts, ensuring they adhere to publication guidelines and timelines. Foster collaboration with key researchers and authors to facilitate publication in reputable journals and presentation to appropriate audiences.
• Ensure that clinical project teams have early, hands-on operational support in clinical trials planning, protocol development, training of internal and external personnel, medical monitoring for trial safety, and quality control.
• Influence executive decision-making regarding prioritization of all projects to obtain critical resources and fundings. Allocate/re-allocate internal and external resources as needed to meet project objectives and timelines.
• Stay abreast of advancements in clinical science, therapeutic trends, and regulatory guidelines – providing expertise to the Division on forward-looking product development and clinical strategy.
• Partner with the Endoscopy Chief Medical Officer to build and maintain relationships with external Key Opinion Leaders, academic institutions, and professional societies to enhance the organization's scientific credibility and reputation, and to provide meaningful insights into Endoscopy's clinical research strategies.
• Support clinical diligence associated with business development, merger, and acquisition initiatives.
• Assist in the development and implementation of a comprehensive scientific communications strategy aligned with the organization's overall goals and objectives. Collaborate with key stakeholders to identify communication priorities and target audiences.

Management Requirements:

• Lead a large multi-level Clinical and Scientific Affairs function in the achievement of organizational goals. Guide, coach, direct, and develop direct reports.
• Foster a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
• Talent management - Hiring, developing and retaining a high-performing and diverse clinical team
• Direct and control the activities and budget of one or more functional areas.
• Monitor and ensure compliance with company policies and procedures (e.g., federal/country and regulatory requirements

Qualifications:

• MD or PhD in the medical sciences
• 10+ years clinical, medical and/or industry experience (device, pharmaceutical, biotechnology, academic medicine), including 5+ years in managerial capacity.
• Clinical trials experience – protocol design, site selection and start-up, trial conduct and monitoring, and distribution of results including assisting in publishing results in peer reviewed journals and having them presented at professional organization meetings.
• Strong interpersonal skills to enable cross functional and cross franchise success.
• Demonstrated success in managing complex teams.
• Excellent oral communication skills (articulate and persuasive) to foster cogent presentations to both scientific and non-scientific groups.
• Demonstrated written and oral presentation skills with a commitment to excellence.
• Demonstrated high degree of integrity, professionalism, and an ability to establish credibility internally and externally.
• High sense of urgency and commitment to execution