Director, Scientific Communications & Medical Information

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 Director of Scientific Communications & Medical Information at Meitheal Pharmaceuticals is responsible for leading the strategic development, implementation, and execution of scientific communication and medical information activities. This role is critical in ensuring that internal and external stakeholders receive timely, accurate, and impactful scientific information across all therapeutic areas, specifically focusing on Meitheal's infectious disease portfolio, including CONTEPO (IV Fosfomycin) and XENLETA (IV and oral Lefamulin acetate), oncology and other biosimilar immunologic therapies, and numerous pipeline assets, some of which may include E.U. and other ex-U.S. territories.

Pay range for this position is $175,000 - $210,000. 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.

Essential Duties and Responsibilities include the following. Other duties may be assigned.

Leadership and Strategy:

• Lead the development and execution of scientific communication and medical information strategies for Meitheal's product portfolio, particularly focusing on IV Fosfomycin and other key therapeutic areas.
• Oversee the integration of Medical Information, Publications, and Scientific Communications into a high-performing, compliant department, ensuring alignment with Meitheal's overarching medical strategies and cross-functional objectives.

Scientific Communications:

Publication Strategy Development:

• Develop and implement a comprehensive publication strategy for all assigned therapeutic areas and products, with a focus on existing and pipeline therapies. Ensure alignment with product strategies throughout life cycles from early development through post-launch phases.
• Ensure publication strategies are data-driven, scientifically rigorous, and compliant with regulatory guidelines, including GPP (Good Publication Practice) and ICMJE standards.
• Collaborate with clinical, regulatory, and medical affairs team members to ensure publications align with clinical development milestones, regulatory submissions, and post-marketing commitments, particularly for products like CONTEPO (IV Fosfomycin) and XENLETA (IV and oral Lefamulin acetate).

Publication Execution and Oversight:

• Lead cross-functional teams, including medical writers and external medical communication agencies, in the development, writing, editing, and submission of high-quality scientific manuscripts, abstracts, posters, and oral presentations related to Meitheal's key products. This includes curating ex-US clinical information that may be available for some assets.
• Serve as the primary contact for internal and external stakeholders to ensure transparency, timeliness, and alignment in the publication process.
• Establish and manage publication steering committees and advisory boards, involving key opinion leaders to guide publication strategy, with particular emphasis on the therapeutic areas of infectious diseases and immunology.

Stakeholder Engagement and Relationship Management:

• Build and maintain strong relationships with KOLs, investigators, journal editors, and congress organizers to enhance the visibility and impact of Meitheal's scientific communications on Meitheal therapies.
• Engage with internal departments (e.g., Clinical Development, Regulatory Affairs, Commercial, Market Access) to align publication strategies with broader corporate objectives, ensuring that key therapeutic areas are well represented.
• Congress planning and facilitation for Meitheal's participation
• Assist cross-functional team in the creation of dossiers and hospital formulary kits.

Medical Information:

Medical Information Strategy:

• Develop and implement a medical information strategy that supports Meitheal's products, particularly Meitheal's novel molecules CONTEPO (IV Fosfomycin) and XENLETA (IV and oral Lefamulin acetate).
• The strategy should ensure that healthcare providers, patients, and consumers receive timely, accurate, and fair-balanced medical information.
• Lead the strategic planning and operational execution of Medical Information services, including developing standard responses and content creation tailored to Meitheal's therapeutic areas.

Medical Information Services Management:

• Oversee the operation of Medical Information Call Centers, ensuring inquiries about Meitheal's new products and other assets are handled in compliance with regulatory requirements.
• Lead the development and maintenance of a comprehensive database of Medical Information responses, ensuring accuracy and scientific integrity, with regular updates based on the latest data from clinical studies and regulatory approvals.

Data Analysis and Insights:

• Develop and implement KPIs to monitor the effectiveness of Medical Information services, including response times and customer satisfaction, with a focus on inquiries related to IV Fosfomycin and biosimilars.

Regulatory Compliance and Documentation:

• Establish and enforce policies and procedures to ensure that all Medical Information activities comply with regulatory requirements, particularly those related to IV Fosfomycin and biosimilars, providing audit-ready records.

Qualifications

• Minimum of 10+ years of experience in the biotech/pharmaceutical industry, with 4+ years background in Scientific Communications and Medical Information.
• Proven experience managing cross-functional teams in an organization, particularly within the infectious disease, oncology, and immunology therapeutic areas.
• Sound understanding of the drug development process, timing, particularly for impactful publication planning and medical information services.
• Experience with regulatory compliance and industry standards governing scientific communication and medical information, with a focus on infectious diseases.
• Advanced scientific or medical degree (R.Ph., Ph.D., equivalent) strongly preferred but not required
• Strong leadership and strategic thinking skills, with the ability to drive operational excellence.
• Excellent communication skills, both verbal and written, with experience presenting to senior leadership.
• Demonstrated ability to manage complex projects and solve problems in a matrix environment.
• In-depth understanding of regulatory guidelines and compliance requirements.
• Ability to travel up to 25% domestically, as needed. May be more if hybrid.

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.