Title: Senior Director, Head of Compliance
Location: Concord, MA
Reporting to: Vice President of Legal
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 Diseases.
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
ITF Therapeutics is seeking an experienced and motivated Head of Compliance to lead the compliance function for the U.S. operations. This critical role will ensure that ITF Therapeutics maintains the highest standards of healthcare compliance and ethical conduct in its operations, with a focus on U.S. pharmaceutical laws and regulations. Reporting to the Vice President of Legal, the Head of Compliance will work closely with the senior leadership team and play a key role in shaping and maintaining a robust compliance program that supports ITF Therapeutics' mission to address unmet medical needs for rare disease communities.
Primary Responsibilities:
Compliance Leadership and Strategy:
Healthcare Compliance:
Risk Assessment and Mitigation:
Training and Education:
Policies and Procedures:
Collaboration and Liaison:
Required Skills:
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