About the Company

ITF Therapeutics is the U.S.-based rare disease division of Italfarmaco S.p.A., a private multinational group headquartered in Milan, Italy. Established in 1938, its mission has been to improve patient lives and overall well-being through pioneering research & development, high-quality production, and global marketing of branded prescription and non-prescription products. Operating in the pharmaceutical and API development, Italfarmaco Group has a presence in over 90 countries, employs 3,800 individuals, including 300 professionals across its four Research & Development Hubs, and generates a turnover exceeding 1 billion Euros. The group is known for its products in key therapeutic areas such as Women's Health, neurology and Psychiatry, Cardiovascular and metabolic, and Rare disease.

In January 2024, Italfarmaco launched ITF Therapeutics as a new division in the United States with a focus on the development and commercialization of products to treat rare diseases including Duchenne muscular dystrophy (DMD), a rare and severe form of muscular dystrophy. Highlighting this commitment, ITF Therapeutics successfully secured FDA approval in March 2024 for Givinostat, the first nonsteroidal medication approved to treat all genetic variants of DMD in patients six years of age and older. Givinostat is a histone deacetylase (HDAC) inhibitor that has shown potential in reducing inflammation and fibrosis in muscles, thereby slowing the progression of the disease. Building on a legacy grounded in collaboration and innovation, ITF Therapeutics strive to partner with leaders from the U.S. patient advocacy and treatment communities to ensure that our programs reflect and support their unique needs and goals. The establishment of ITF Therapeutics also reflects Italfarmaco’s goal to build a world-class team of experts that share a passion to make a positive impact for rare disease communities.

The Role

The Associate Director, Medical Operations will be responsible for leading the day-to-day medical affairs and patient advocacy operations. Reporting to the Head of Medical Operations, you will play a critical role in providing scientific and medical operational leadership to execute on the realization of medical strategies and activities while helping lead scientific communication to investors, key stakeholders, and beyond.

Primary Responsibilities:

• Partner with Medical Affairs leadership to help develop and execute a comprehensive Medical Affairs strategy.
• Oversee implementation and management of daily operations in fulfillment of Medical Affairs strategic plans and initiatives, including creating and managing dashboards and reviewing and interpreting key data to derive statistic insights.
• Lead management of Medical Affairs budget in collaboration with Head of Medical Affairs
• Manage Medical, Legal and Regulatory (MLR) review for all Medical Affairs, communications, and advocacy activities, including establishing and leading the medical grants and giving process.
• Act as a liaison both internally and externally, focusing on building open lines of communication with key external and internal stakeholders.
• Manage advocacy conference presence and collaborate with commercial team on all conference activities. Devise and lead the execution of conference strategy.
• Establish and maintain effective partnerships with agency and vendor partners and other external partners. Manage the contracting process and follow ups, PO, invoicing, and agreements.
• Support medical communications activities and initiatives with both internal and external audiences, including supporting future intranet activities and managing social media channels and the corporate website, and managing medical affairs inquiries and follow ups.

Required Skills:

• Demonstrated history working in Medical Affairs in a small pharmaceutical or biotech company. Startup experience preferred.
• Proven experience with independent leadership of medical affairs operations initiatives.
• Ability to use data to generate strategic medical affairs insights and apply them toward creating a comprehensive medical affairs strategy.
• Strong understanding of medical operations compliance to include medical education and research best practices.
• Outstanding communication skills and the ability to generate strong relationships with all kinds of external audiences as well as across internal departments.
• Pharmaceutical launch experience required.
• Independent mindset to lead medical affairs functions with minimal daily input.
• Ability to travel up to 20% for conferences and meetings.