Medical Director, Pulmonary

Main Responsibilities:
- Develop strategy and tactics for an integrated Medical Plan (Medical Education, Medical Communications & Publications, Health Outcomes, Safety, Clinical Research including Phase IIIB-IV and Investigator Sponsored Trials) and annual budget for assigned therapeutic area products
- Execute the Integrated Medical Plan to ensure on-time, on-budget delivery of tactical activities and deliverables
- Communicate Medical Plan details/progress to Management, the Core Team, and execution stakeholders
- Provide evidence/data to ensure strategy aligns with clinical development and commercial objectives
- Generate and communicate scientific/medical insights; develop/execute Medical Engagement Plans
- Provide medical strategy and expertise to Clinical, Commercial, Market Access, and Regulatory partners
- Ensure cross-functional alignment to support safe and appropriate use of therapeutic area products
- Provide medical leadership to sales, marketing, legal, and regulatory functions for marketed products and drugs in development
- Provide scientific guidance and collaborate with field, marketing, HEVA, Market Access, and sales teams
- Partner with Field Medical Head and Medical Directors to manage regional stakeholder relationships, engagement planning, and tactical budget
- Collaborate with health economics to address questions and opportunities
- Provide medical review/approval of promotional and medical materials; review/approve medical and scientific content for multiple functions’ materials
- Review medical education grant applications and training materials
- Maintain knowledge/adherence to applicable guidance and regulations (e.g., FDA, OIG, DDMAC/OPDP, PhRMA, ICMJE, ISPOR)
- Support execution of US Phase IIIB-IV programs (protocols, CRFs, reports, SAPs, guidelines, timely study reporting)
- Oversee clinical studies per GCP/ICH and company standards; review/approve IST concepts/protocols
- Identify/co-create research collaborations; identify and oversee post-marketing trials/registries
- Ensure company/IST data are presented publicly in a timely, fair, balanced manner
- Partner with US Drug Safety on adverse events, post-marketing safety, and safety signal communication
- Identify/communicate Product Alerts to the Core Team
- Develop relationships with Key Thought Leaders; lead/enable medical and scientific advisory boards and external advisory boards
- Represent the company at meetings; provide disease state/product training; stay current on therapeutic area literature and developments
- Perform other duties as assigned

Qualifications & Skills:
- Advance degree in life sciences/pharmaceutical sciences (PhD, PharmD, PA, NP or MD with relevant experience)
- Minimum 5 years of relevant experience in Medical Affairs
- Strong track record developing/executing US medical strategies
- Clinical or medical affairs experience in Pulmonary and/or Immunology (strongly preferred)
- Industry experience in Medical Affairs and/or Clinical Development, including launch and Life Cycle Management
- Knowledge of healthcare systems, regulatory/payer environment, and public health/industry trends
- Sound scientific and clinical judgment; understanding of scientific method and clinical applications
- In-depth understanding of clinical trial design and conduct (clinical trial design/execution preferred)
- Ability to translate innovation into actionable plans; strategic thinking
- Effective internal/external stakeholder management in a complex matrix environment
- Broad leadership experience and strong leadership presence
- Ability to communicate scientific/medical data to internal and external stakeholders
- Change management mindset; strong analytical and problem-solving skills
- Digital literacy
- Knowledge of pharmacovigilance and local regulatory process
- Travel up to 35%

Benefits:
- Health and wellbeing benefits including high-quality healthcare and prevention/wellness programs
- At least 14 weeks’ gender-neutral parental leave

Application instructions:
- Not specified in the provided text.