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Description
About Us: Founded in 2017 and based in Chicago, Meitheal is focused on the development and commercialization of generic injectable medications and, as of 2022, has expanded its focus to include fertility, biologic, and branded products. Meitheal currently markets over 60 U.S. Food and Drug Administration (FDA)-approved products across numerous therapeutic areas including anti-infectives, oncolytics, intensive care, and fertility. As of January 2025, Meitheal, directly or through its partners, has 19 products in the research and development phase, 22 additional products planned for launch in 2025, and 24 products under review by the FDA. Meitheal's mission is to provide easy access to fairly priced products through robust manufacturing, consistent supply, and rapid response to our customers' needs. Ranked #2 in 2024 on Crain's Fast 50 in Chicago, and in the top 100 of Crain's Best Places to Work in Chicago from 2022 to 2024, Meitheal emulates the traditional Irish guiding principle we are named for - working together toward a common goal, for the greater good. Position Summary: The Head of Global Medical Affairs is a senior executive responsible for the strategic direction, execution, and oversight of medical and scientific affairs across Meitheal's infectious disease portfolio and immunologic therapies, with a near-term focus on the U.S. launch of CONTEPO (IV Fosfomycin) and XENLETA (IV and oral Lefamulin acetate). This leader will drive the medical strategy, scientific communication, evidence generation, and the MSL KOL engagement efforts while ensuring compliance with global regulations. The role requires a deep understanding of the Medical Affairs department functions being built, external medical landscape, strong people and cross functional leadership skills, and the ability to integrate scientific insights into product development, commercialization, and lifecycle management. The ideal candidate will be an entrepreneurial thinker with a proven track record of building and leading high-performing medical affairs teams within biotech or pharmaceutical companies. Pay range for this position is $350,000 - $420,000. Payrate is determined by considering a person's prior experience and competence. The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. Why Work with Us?
- Hybrid Work Schedule (Preferred): Enjoy the flexibility to work remotely three days a week.
- Casual Dress Code: Embrace a relaxed and comfortable dress code that allows you to express your personal style.
- Collaborative Culture: Join a team that values open communication, teamwork, and the exchange of ideas.
- Professional Growth: We offer ample opportunities for professional development and career advancement.
Key Responsibilities Strategic Leadership & Execution
- As a forming Medical Affairs department, the Head of Global Medical Affairs has the opportunity to shape how an exceptional Medical Affairs department can operate and positively impact patient care.
- Developand implement a global medical affairs strategy aligned with corporate objectives and product lifecycle needs.
- Oversee the execution of medical plans in the U.S. with contributions to multiple ex-U.S. regions across therapeutic areas, ensuring integration of regulatory, clinical, HEOR, and commercial perspectives.
- Lead the development and execution of medical education, scientific exchange, and evidence-generation initiatives to support the safe and effective use of Meitheal's products.
- Act as a strategic thought partner across R&D, regulatory, commercial, and market access teams.
- Provide medical and scientific leadership for late-stage clinical development programs, ensuring alignment with business and regulatory strategies.
- Direct reports will include Medical Science Liaisons
Scientific & Medical Engagement
- Establish and maintain strong, trusted relationships with Key Opinion Leaders (KOLs), academic institutions, medical societies, and patient advocacy groups.
- Work through the field medical team to develop a comprehensive KOL engagement and insights-generation strategy to support product development and launch readiness.
- Represent Meitheal at global medical conferences, advisory boards, regulatory discussions, and investor meetings.
Evidence Generation & Scientific Communication
- Drive data generation strategies, including investigator-initiated studies, real-world evidence, retrospective analysis and burden-of-disease evaluations.
- Work closely with Scientific Communications to develop and execute a strategic publications plan, ensuring peer-reviewed publications, congress presentations, and scientific symposia reflect corporate priorities.
- Lead cross-functional collaboration on integrated evidence plans to align medical, regulatory, HEOR, and commercial objectives.
Compliance & Governance
- Ensure all medical affairs activities comply with global regulatory requirements, industry standards, and company policies.
- Develop medical governance frameworks to maintain high ethical and compliance standards in all engagements.
Team Leadership & Organizational Development
- Build and lead a high-performing, agile global medical affairs team.
- Recruit, develop, and mentor top medical affairs talent, fostering a culture of collaboration, innovation, and scientific excellence.
- Manage the medical affairs budget, ensuring optimal resource allocation.
- Implement best-in-class systems and processes to streamline medical affairs operations.
Requirements
Key Qualifications & Experience Education & Expertise
- MD, PhD, or PharmD required (preference for candidates with clinical training in infectious disease, oncology, hematology, and/or immunology).
- Minimum 15+ years of experience in Pharma/Biotech, 10+ years Medical Affairs department, including leadership roles in biotech/pharmaceutical companies.
- At least 2 years of experience as Head of Medical Affairs.
Core Competencies & Skills
- Entrepreneurial mindset with the ability to thrive in a fast-paced, high-growth environment.
- Strategic thinker with outstanding analytical and problem-solving abilities.
- Exceptional communication skills, with the ability to engage internal and external stakeholders, including KOLs, regulators, and commercial teams.
- Strong operational execution, balancing high-level strategic vision with hands-on leadership.
- Comprehensive knowledge of regulatory requirements, compliance, and industry standards.
- Ability to travel up to 50% for key meetings, conferences, and KOL engagement.
Equal Opportunity Employer: Meitheal Pharmaceuticals is an Equal Opportunity Employer. We welcome and encourage applications from all qualified individuals, including minorities, women, veterans, and individuals with disabilities.
Salary Description
$350,000 - $420,000
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