Medical Director, Medical Affairs - Apnimed

Apnimed is a well-funded, clinical-stage pharmaceutical company working to transform the treatment of sleep apnea based on a simple idea – patients with obstructive sleep apnea could benefit from treatment with a safe and effective oral medication dosed once daily at bedtime. Our lead development program targets the neurologic control of upper airway muscles to maintain an open airway during sleep. Based in Cambridge, Mass., Apnimed is conducting cutting edge research and committed to innovation as well as state-of-the-art advancements in sleep medicine, which is leading to the development of a portfolio of novel pharmacologic therapies for sleep apnea and related disorders. Of note, the Boston Business Journal has also voted Apnimed as one of the Best Places to Work in 2024.

The Medical Director, Medical Affairs, will be responsible for leading the strategic planning and tactical execution of a high-impact medical pre-launch and launch plan for Apnimed’s lead compound, AD109. The Medical Director is a highly visible internal and external-facing role, engaging cross-functionally within Apnimed and with key leaders in the scientific and payer communities. The ideal candidate will be a true medical “triple threat” demonstrating high levels of scientific excellence, business acumen, and emotional intelligence.

This leader will report to the Vice President, Medical Affairs, and may be based in Apnimed headquarters in Cambridge, Massachusetts, or based remotely with travel to the home office as needed.

Key Job Duties include, but are not limited to:

• Lead the development and execution of a high-impact Medical Affairs pre-launch and launch strategy for AD109 and related tactical plans and associated budgets
• Collaborate cross-functionally to develop a comprehensive medical congress strategy and provide input into publication strategy
• Develop and manage the priorities and process for medical education, including CME/IME strategy, as well as investigator-initiated research
• Collaborate with R&D colleagues to develop a targeted KOL engagement strategy, including KOL identification and mapping
• Engage with KOLs and investigators to develop and execute advisory board meetings
• Generate medical insights and assess the evolving external scientific and clinical environment to inform medical and brand strategies
• Establish strong and collaborative working relationships with cross-functional internal colleagues and scientific engagement with key external stakeholders, including KOLs, key payer accounts, medical societies, and industry colleagues
• As a SME for OSA and AD109, act as a clinical expert for internal and external stakeholders and provide internal training for Medical and Commercial teams
• Provide medical and scientific review for internal and external medical and commercial materials, including materials in the MLR process

Education

• Doctoral degree in life sciences (MD, PhD, PharmD or clinical doctorate degree required)
• Clinical training and experience with direct patient care is highly desirable, especially in pulmonary, neuroscience, sleep medicine or other chronic disease area
• Additional training or experience in public health, health policy, of health care management is preferred

Work-related Skills & Experience

• 7+ years of biopharmaceutical industry experience in U.S. Medical Affairs required, preferably in both headquarters and field-based roles, ideally in both small and larger companies
• Experience with multiple product launches through late development, regulatory filing, approval and launch
• Additional experience in Clinical Development, Market Access, Regulatory Affairs preferred
• Strong ability to critically evaluate and interpret new scientific data in the context of existing literature, and determine significance for patients, providers, payers, and the company
• Demonstrated ability to think strategically and execute with agility; able to “get the right things done well”
• Strong ability to “roll up one’s sleeves”
• Highly resourceful, self-motivated and works well independently while leveraging strengths of a cross-functional team
• Flexible and open to feedback, can adjust strategy and pivot based on evolving needs and insights
• Keen ability to quickly and consistently build and maintain high levels of trust with internal and external colleagues
• Excellent written and verbal communication skills, and proven ability to work collaboratively in a cross-functional environment
• Strong problem solving and risk mitigation skills
• Unimpeached track record of the highest levels of integrity, honesty, and ethics
• Thorough knowledge of current Good Clinical Practice (GCP, ICH), as well as all FDA guidances relevant to Medical Affairs activities
• Ability to travel, up to 20%, mainly in U.S.

What Apnimed Offers:

• 401(k) with company match
• Generous time off for vacation
• Generous healthcare benefits
• Flexible working environment
• Motivated and experienced team

Location and Other Information:

• Apnimed is a privately held company based in Cambridge, MA; we are generally virtual and specific location within the US is flexible.
• Apnimed is an EEO employer committed to an exciting, diverse, and enriching work environment.
• Please visit us at www.apnimed.com to learn more about our work with Obstructive Sleep Apnea