Head of Medical and Clinical

The Head of Medical & Clinical, positioned in the Medical Office, is responsible for leading multidisciplinary teams comprising Medical Affairs, Clinical Affairs, Medical Safety, Health Economics and Market Access and Reimbursement focused on the Ambulatory Monitoring & Diagnostics Business with a high degree of complexity. The role drives to meet strategic business needs and optimize portfolio decisions. The role ensures the development of clinical and economic evidence strategies drives innovation and delivers value to stakeholders for both new and existing products. The role oversees clinical risk assessments for products both pre- and post-market and contributes to risk remediation and de-risking strategies. The role leads to talent development initiatives, building and fostering critical competencies in robust scientific thinking to address current and future clinical evidence challenges. The role oversees all operational processes of Medical and Clinical Affairs, outcomes research, and lifecycle management, including diligence for business development and M&A activities.

ROLE RESPONSIBILITIES:

• Responsible for leading Medical Office multidisciplinary teams comprising Medical Affairs, Clinical Affairs, Medical Safety, Health Economics and Market Access and Reimbursement, focused on Ambulatory Monitoring & Diagnostics with high complexity.
• Level of complexity stemming from factors as size of the business, geographical footprint, portfolio choices, business maturity and strategic choices of the business.
• Lead succession planning and comprehensive talent management, driving employee selection, performance management, compensation management, and career development in alignment with organizational operational goals.
• Cultivate a high-performance team culture, encourages cross-functional collaboration and establishes a sustainable talent pipeline, nurturing talent development and succession planning to support long-term organizational success.
• Oversee the development of critical competencies for the Medical Affairs, Medical Safety and Clinical Affairs functions, driving the development of innovative medical and clinical strategies to support product development and commercialization.
• Serve as the Medical & Clinical representative towards AM&D business leadership, provides clinical/medical thought leadership for business strategic decisions, product roadmap, solutions innovation, and market expansions, coordinating with the central team to set resource needs and allocation expectations and foster cross-functional collaboration.
• Recommend and guide successful organizational transformation initiatives, provide guidance in developing talent with critical competencies in robust scientific thinking to meet current and future clinical evidence challenges.
• Drive the development of innovative medical and clinical strategies to support product development and commercialization, delivering value-based evidence to stakeholders for product registration, adoption, and market development.
• Assume accountability for product-related aspects such as submissions, registration, maintenance, and evidence generation, including study design and execution to provide proof points for clinical and economic benefit claims.
• Provide vigilant oversight of pre- and post-market safety management, ensuring compliance and maintaining patient safety standards, and contributes to risk remediation and de-risking where appropriate.
• Ensure coordination with the central team to address resource needs and set allocation expectations for health economics and market access.
• Provide medical and clinical expertise to support regulatory submissions and compliance, and oversee all Medical and Clinical Affairs, and outcomes research operational processes throughout the lifecycle including M&A due diligence and Business Development.
• Influence the organizational direction relative to global external stakeholders' needs, initiating, overseeing, and guiding activities throughout all disciplines to position the organization as a leader in safety, performance, and compliance.
• Develop and maintain strong relationships with key opinion leaders, healthcare professionals, and academic institutions to support the company's scientific and clinical objectives.
• Represent the organization at medical and scientific conferences, meetings, and other events, serving as a key opinion leader, maintaining a high level of visibility in the medical community.

QUALIFICATIONS and EXPERIENCE:

• Doctor of Medicine (MD) or equivalent with proven clinical practice in the medical field
• 12+ years of experience in areas such as Medical Operations, Clinical Affairs, Medical Safety, Market Access, Diagnostics, Imaging and Software, Health Economics and Outcomes Research or equivalent
• 10+ years of Leadership experience in a highly regulated environment of Medical Devices, Diagnostics, Imaging and Software, Clinical Practice, Health Management or equivalent
• Familiar with Business Process Management and Functional Oversight at a large-scale health tech organization
• Demonstrated success in driving the function’s value in product registration, market development and indication expansion
• In-depth knowledge of pre-market and post-market safety global standards and regulations, as the primary organizational expert
• Commercial acumen and customer-focused solutions thinking
• Ability to effectively lead, influence and manage in a highly matrixed, global environment.
• Excellent interpersonal, organizational, negotiation and presentation skills with the ability to motivate, inspire and evangelize.
• Must be able to successfully perform the minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.