Chief Medical Officer - #1693662

Description

Job Summary:

The Chief Medical Officer will provide clinical expertise, strategy, and functional leadership in the planning, development, and commercialization of new products in oxygen therapy, non-invasive ventilation therapy and potentially respiratory health. The role’s primary focus will be to transform patient care through progressively integrating the adoption of portable oxygen therapy and noninvasive ventilation into clinical practice guidelines, treatment pathways, and patient care management, as well as obtaining regulatory approvals in keeping with business objectives. This role will work across the functions to ensure alignment with corporate goals and objectives, including critical partnerships with Product Development, Marketing, Commercial, Market Access, Regulatory and Government Affairs. Additionally, the role will provide oversight of the strategic engagement of top KOLs, centers of excellence and professional societies, development of in-country clinical evidence, ensuring support of external partnerships with third parties who complement our internal capabilities and are interested in developing complimentary solutions.

Responsibilities

• Build out and lead a best-in-class Medical Affairs Organization, develop new functional capabilities (e.g., MSLs) and implement necessary processes and procedures to serve business compliantly, effectively, and efficiently.
• Develop the Medical Affairs strategy in alignment with global strategy and oversee the execution of the Medical Affairs plan of action (i.e., Evidence Generation, Medical and Economic, KOL and professional societies engagement plan, Scientific Advisory Board meetings) in support of product development, launch, adoption, and reimbursement.
• Oversee the Medical Affairs evidence generation strategies, study concepts, and proposals, and ensure that clinical data are available to support treatment guidelines development.
• Oversee and manage medical support for developmental and validation activities.
• Develop and enhance relationships and communication with the critical professional societies and scientific/medical communities, and physician thought leaders by promoting our scientific image in developing clinical data.
• Work in partnership with R&D functions to identify and evaluate clinical use cases for oxygen therapy, non-invasive ventilation, or respiratory health, or product improvements, technologies, and intellectual properties.
• Provide Medical Affairs input and support of the Product Development and Product Commercialization processes.
• Collaborate with Market Access/Health Economics and Outcome Research (HEOR) to shape the evidence generation and communication strategy (e.g., Value Dossier) according to the US payer needs and to achieve and optimize reimbursement.
• Have accountability to define, implement and enforce the AdProm policy (advertising promotion policy).
• Support Investigator Sponsored Studies, where applicable, and have the responsibility for research grant review and approval.
• Oversee the selection, funding of educational grants (if and when applicable).
• Responsible for optimizing the procurement strategy for clinical operations services and establish strategic relationships with the service providers and key investigators (if outsourcing is applicable, now or in the future), and managing the Medical Affairs budget in line with corporate guidelines.
• Provide medical direction and guidance across the business through the cross-functional collaboration.
• Participate in local, regional, and international meetings, congress, and symposia, contributing to the planning and organization.
• Fosters a leadership culture, which attracts, develops and retain high caliber candidates, helping to build and shape a Medical Affairs talent pool to support business growth.
• Shape the Medical Affairs Organization, coach, lead, and develop the team.
• Develop a highly accountable team culture and assure compliance with relevant corporate and regulatory guidelines.
• Assist in obtaining all necessary regulatory registrations, approvals, certifications or other documents required to maintain ISO 13485-2016, MDSAP and FDA registration to facilitate the sale of Inogen products in US, State of California, European, Canadian, China and other international markets as determined by business objectives.
• Participate in product development activities. Ensuring regulatory standards are understood, design control system is in place, design validation activities are conducted, and Design History File are maintained to support regulatory submissions.
• Ensure standardization exists between operations in all Inogen facilities. Including compliance standardization for all departments associated with the service aspect of the business as well as Regulatory standardization for departments and groups associated with the design, manufacturing and processing of medical equipment.
• Oversee post market surveillance (PMS) and vigilance activities, including customer complaint/adverse medical event reporting systems, clinical reports, etc.
• Manage the document control and training activities associated with product manufacturing, packaging, and regulatory requirements.
• Manage assigned staff and contracted consultants.
• Manage department activities per approved budget and annual operating plan.
• Comply with all company policies and procedures.
• Assist with any other duties as assigned.
  
  

Knowledge, Skills, And Additional Enabling Competencies

• Drive Organizational Success: Sets and pursues aggressive goals, demonstrating strong commitment to organizational success.
• Lead boldly: takes decisive action and leads through difficult initiatives, championing new ideas and initiatives.
• Use Astute Judgement: applies seasoned judgement to make timely, effective decisions.
• Earn Unwavering Trust: Acts as a role model for credibility and high personal integrity.
• A strong change agent.
• Entrepreneurial and engaging.
• Must have strong work ethic.
• Excellent oral and written communication skills required.
• Attention to detail is required.
• Effective conflict resolution.
• Analytical & problem-solving skills & ability to multitask.
• Solutions-oriented problem solver.
• Excellent leadership and communication skills required, with ability to lead cross-functional teams and build consensus.
• Strong presentation skills, including comfort level in corporate board rooms and with the investment community.
• Demonstrated track record of building new teams and functions.
• Excellent cross-functional leadership experience in highly matrixed setting.
• Preferably an established network of key thought leaders and physicians involved in respiratory health, in the US and Globally.
• Ability to travel 20-30%.
• Ability to independently deliver quality results in a timely manner.
• Excellent English (written, oral) mandatory; fluency in multiple languages preferred.
• In-depth knowledge of FDA, ISO 13485 and MDSAP programs and a track record of successfully implementing and maintaining these programs globally.
• Strong project management and organizational skills. Ability to systematically monitor, detect and improve regulatory, quality and compliance programs.
• Business acumen – able translate business strategy and objectives into a regulatory program. Able to show flexibility in approach depending on the business need.
  
  

Qualifications (Experience And Education)

• MD; MD/Ph.D., required; Pulmonologist, preferred.
• 15+ years of significant leadership experience within Medical Affairs, working in respiratory diseases and respiratory health, required; with 5+ years of experience in academic research, investigators-sponsored or collaborative research, real-world data generation, registry and cohorts research, required; 7+ years’ experience in Regulatory Affairs for a medical device manufacturing company, required.
• 10+ years management experience, with a minimum of five direct reports, required.
• 3 years’ experience in a Director level position, required.
• 2 years’ of experience in at least three of the following areas: product development, manufacturing engineering, materials management, regulatory affairs, product management, required.
• Advanced knowledge/proficiency in Microsoft Office, required.
• A combination of training, education and experience that is equivalent to the qualifications listed above and that provides the required knowledge, skills, and abilities.