Director, US Medical Affairs Lead

Description

Job Summary

We are seeking a Director of Medical Affairs to lead key medical and clinical affairs activities across the department. Reporting to the Chief Medical Officer, this role leads the overall activities of US Medical Affairs, including Evidence Generation, Scientific Exchange, and Publication activities. As part of the Core Teams, the role interacts with the key commercial, regulatory, R&D, and operations functions. The role will identify and engage HCPs and patient advocacy groups through collaborative partnerships to enhance educational initiatives, advance the appropriate application of therapies that provide patient-centric outcomes, and advise the medical and clinical affairs department on matters of strategic importance, including clinical trials.

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

• Lead business and operational planning across key medical activities including Medical Information, Medical Communications and Publication planning, and Grants and Medical Education.
• Develop as needed and support a network of scientific experts and medical key opinion leaders, and other stakeholders in the respiratory field, academic institutions, and healthcare organizations.
• Lead the efforts of establishing strong relationships with relevant patient advocacy groups and identify gaps in patient education and areas of improvement.
• US Medical Affairs Lead plays a crucial role in ensuring that physicians have accurate and up-to-date information about our products and therapeutic area. Furthermore, the individual will provide product and pipeline therapeutic area expertise to address KOL and HCP inquiries.
• Collaborate with cross-functional teams, including R&D, Clinical Operations, Marketing, and Sales, to ensure alignment and integration of medical affairs activities and support launch, reimbursement, and product development activities.
• Facilitate scientific exchange and provide education on Inogen’s products, therapeutic area, disease state, clinical trials, and research initiatives via in-person or virtual interactions, presentations, conferences, etc.
• Respond to unsolicited inquiries from healthcare professionals regarding our products, clinical trials, therapeutic area, and medical literature.
• Provide scientific and clinical insights to support the development and execution of clinical trials, publications, and medical education programs.
• Support scientific research and collaboration, IIR submissions and grants through appropriate internal processes, and interact with current IIR investigators to maintain site engagement and address any unsolicited trial-related questions.
• Serve as the focal point for medical know-how by regularly reviewing clinical articles and attending scientific/medical meetings, advisory boards, and conferences to both internal and external stakeholders.
• Design and implement clinical training curriculums by assessing and analyzing organizational, HCP, and patient advocacy requirements, obtaining educational content through participation in cross-functional teams, congresses, forums, and meetings.
• Work closely with the sales organization to support team’s ability to understand clinical information and identify insights based on their field experience.
• Create insights-based summaries on a regular basis to guide the MA department strategy based on various stakeholder engagement.
• Ensure robust compliance related to regulations on training, education, and HCP interactions are followed.
• Perform various assigned duties as needed based on evolving needs of the department.

Knowledge, Skills, and Abilities

• Strategic thinker with a strong focus on education, adherence to compliance guidelines, and operational efficiency.
• Ability to interpret scientific data, be current on clinical competitive landscape, and have strong scientific writing skills.
• Strong knowledge and understanding of FDA regulations, GCP, and ISO 14155, specific to medical devices.
• Must possess excellent verbal and written communication skills and work effectively in a demanding, fast-paced environment.
• Excellent organizational, relationship-building skills, and leadership skills, capable of motivating a matrix team and managing multiple projects.
• Detail-oriented with strong problem-solving skills and ability to adapt to work collaboratively with different cross-functional teams at a global level.
• Promote a culture of integrity, transparency, and ethical behavior within the organization.
• Ability to develop and execute clinical study protocols, specifically in the area of respiratory care.
• Ability to manage conflict, drive consensus, and promote decision-making.
• Anticipates business and industry issues; recommends relevant process improvements.
• Sees the broader picture and longer-term impact on division/company.

Qualifications (Experience and Education)

• Advanced degree (MD, PhD, or PharmD) in a relevant scientific discipline. Preferable experience in the respiratory space.
• 10+ years of experience in the pharmaceutical or biotechnology industry with relevant transferable experience e.g., licensed mental health professional, academic research, etc. or at least 2 years in a leadership role in medical affairs.
• Extensive knowledge of the respiratory therapeutic area, including current treatment paradigms, clinical trials, and emerging trends (Preferred).
• Advanced knowledge/proficiency with dashboard management, tracking and reporting on functional deliverables, and compliance tracking, required.
• Proven track record of building and maintaining relationships with KOLs and other key stakeholders.
• Experience developing and maintaining relationships with physician customers and field reps.
• Experience with the development of educational content and delivering systematic training.
• Strong understanding of clinical research methodology, biostatistics, and regulatory requirements.
• Excellent communication and presentation skills, with the ability to effectively communicate scientific and medical information to diverse audiences.
• Ability to work independently and collaboratively in a fast-paced, dynamic environment.
• Advanced proficiency with Excel, Word, PowerPoint, Outlook, NCBI, Clinicaltrials.gov, FDA platforms.
• A combination of training, education, and experience that is equivalent to the qualifications listed above and that provides the required knowledge, skills, and abilities.