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., we are developing a portfolio of novel pharmacologic therapies for sleep apnea and related disorders.
The Director, Medical Information, will be responsible for leading, building and managing a world-class Medical Information function to support the launch of Apnimed's lead compound, AD109 and the pipeline to follow. 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, build and manage cutting-edge Medical Information systems, SOPs and best practices to support the company's lead asset, AD109, pre- and post-launch
Lead creation and maintenance of accurate and fair-balanced standard response letters (SRL) and custom responses to unsolicited external medical information requests
Identify, select and manage high-performing partners and vendors to support compliant responses to unsolicited requests for medical information, as well as intake and triage of AE and PQC case reports
Establish, track, and report KPIs for inquiry volume, turn-around times, and customer satisfaction
Identify data gaps and contribute to generation of medical insights to support company and functional strategic planning
Provide in-person medical information support at medical and scientific congresses, including booth-related activities and materials
Lead development, updating, and distribution of AMCP or other payer-related dossiers
Monitor and maintain bibliography of relevant scientific literature for company and disseminates new publications internally, in partnership with Medical Communications team
Collaborate with Pharmacovigilance and Quality teams to design and execute intake and processing of AE and PQC case reports
Supports MLR review process for internal and external medical and commercial materials
Ensure best practices and full compliance with all regulatory, industry, and company requirements for medical information
Provide scientific training to vendors and internal colleagues as needed
Monitor industry trends and innovations and implement best practices to heighten efficiency, quality, and value of medical information.
Education:
Doctoral degree in health sciences (PharmD, MD, PhD, DSc)
Expert knowledge of North American and EU regulatory guidelines and requirements for medical information, adverse event and product complaint case reporting
Work-related Skills & Experience
7+ years of biopharmaceutical industry experience in medical affairs, primarily in medical information, ideally in both large and small companies
Previous experience designing, building and implementing medical information systems, processes (including SOPs) and content to support one or more drug launches
Demonstrated excellence in communication skills (written and oral) including the ability to clearly, concisely, and accurately summarize complex scientific data and medical literature
Current and deep understanding of regulatory and industry guidances, policies, and processes (FDA, EMA, MHRA, phactMI) regarding medical information and promotional review
Successful selection and management of high-performing MI/PV/QC call center and fulfillment vendors from RFP process through contracting, training, implementation, management, and reporting
Experience developing and implementing a robust and compliant online medical information portal with self-service or chatbot functionality
Working knowledge or experience with AI/ML in Medical Information
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" when necessary, and delegate when preferable
Superb project management skills, designing and executing plans to meet timelines and budgets
Keen ability to quickly and consistently build and maintain high levels of trust with internal and external colleagues
Proven ability to build strong working relationships and collaborate effectively with internal and external colleagues
Strong problem solving, risk mitigation and time management skills
Unimpeached track record of the highest levels of integrity, honesty, and ethics
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.
Must be able to travel as necessary.
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