Medical Affairs Director at Inogen in Plano, Texas

Job Description:

Director of Medical Affairs builds and maintains the operational infrastructure and manages business and functional operations across the medical affairs organization. Reporting to the Chief Medical Officer, this role leads the overall activities of Medical Affairs, including Integrated Medical Planning, Evidence Generation, Scientific Exchange and Publication activities. As a part of the Core Teams, the role interacts with the key commercial, regulatory, R&D and operations functions.

Responsibilities (Specific tasks, duties, essential functions of the job)

• Lead business and operational planning across the medical affairs function, provide oversight and execution of key medical activities and related processes, including Medical Information, Medical Communications and Publication planning, Grants and Medical Education


• Review and evaluate business procedures, processes, and resources to ensure efficient and effective medical affairs operations


• Effectively manage Medical Affairs processes such as Grants and Medical Education,


• Promotional and medical material review and approval, medical device safety process, IIS process, medical vendor management, medical customer engagement process, publication and scientific conference planning and management, medical information, and external communication, etc.


• Develop medical content as well as policies and procedures and implement a process for storing and managing it, ensuring high level of operational efficiency and compliance with external rules and regulations and internal standards.


• Develop collaborative working relationships across the organization to effectively manage cross-functionally


• Build and lead the US medical team.


• Develop and support a network of scientific experts and medical key opinion leaders.


• Support scientific collaboration with external stakeholders, IIRs (investigator-initiated research) and collaborative research.


• Develop publication of peer-reviewed manuscripts and presentations in medical/scientific conferences.


• Focal point for medical know-how by regularly reviewing clinical articles and attending scientific/medical meetings and conferences. 


• Provide medical and scientific training and/or support to other team members across all company functions (commercial, market access, marketing etc.).


• Facilitate and review clinical studies to develop and validate cutting edge medical products.


• Track Medical Affairs performance vs. goals using a set of key performance indicators


• Ensure close oversite of financial performance of medical activities vs. budget and ensure timely and appropriate budgets adjustments and forecasting.


• Comply with all company policies and procedures.


• Assist with any other duties as assigned.

Knowledge, Skills, and Abilities

• Excellent organizational, planning, and project execution skills, with an aptitude for details, and an ability to multitask and prioritize in a fast-paced environment.


• Ability to develop and execute of clinical study protocols, specifically in the area of respiratory care.


• Demonstrated experience in developing networks at the academia level to support educational initiatives.


• Outstanding problem solving, communication, presentation, and negotiation skills.


• Knowledge and understanding of clinical reporting, including manual and electronic data capture.


• Ability to manage conflict, drive consensus, and promote decision-making.


• Ability to independently identify and manage project objectives, work plans, timelines, budgets, providing formal and informal status updates to stakeholders as needed.


• Anticipates business and industry issues; recommends relevant process / technical / service improvements.


• Applies in-depth expertise in discipline and broad knowledge of other closely related areas to improve efficiency of team.


• Good leadership, mentoring skills and abilities typically leads lower levels and/or indirect teams.


• Sees broader picture and longer-term impact on division/company.


• Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency.


• Must have strong work ethic.

Qualifications (Experience and Education)

• MD, required; MD/Ph.D. (Pulmonologist), required.


• 12-15 years of Medical Affairs experience required; preferably in medical device/pharma.


• Advanced knowledge/proficiency with dashboard management, tracking and reporting on functional deliverables, and compliance tracking, required.


• 6 years management experience, with a minimum of five direct reports, required.


• Experience in clinical trial design, execution, and data analysis, based on deep Good Clinical Practice knowledge, required.


• Advanced knowledge of respiratory research including health economics outcome research, required.


• Advance 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.