Director, Evidence Generation

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 Director of Evidence Generation will lead the strategic planning and execution of evidence generation activities to support the data needs for ITF Therapeutics. This role requires a deep understanding of medical affairs strategy, research, real-world evidence, and the regulations pertaining to evidence generation. The Director of Evidence Generation will collaborate cross-functionally with internal stakeholders and external partners to ensure that evidence generation efforts align with the company's strategic goals.

Primary Responsibilities:

• Lead the development and oversee the implementation of activities to drive evidence generation in support of company strategic goals. Identify gaps in evidence generation and develop approaches to generate data. Ideate and implement new and effective methods of evidence generation to fit the changing needs of customers and key stakeholders.
• Oversee real-world evidence studies and study analyses in support of cross-functional strategic goals.
• Standardize SOPs and data collection methods for all evidence generation activities.
• Oversee the creation of data management systems to aggregate, analyze, and report on data from evidence generation activities.
• Develop actionable insights from study results and advise on next steps.
• Work across departments to obtain feedback and results from the patient population and other relevant stakeholders.
• Ensure that all evidence generation activities are compliant with rules and regulations associated with clinical studies and pharmaceutical development.
• Collaborate with the Medical Communcations and Marketing teams to communicate results of evidence generation activities to both internal and external stakeholders, making complex information and concepts accessible to a wide audience.
• Serve as evidence generation liaison to relevant regulatory and partner bodies.
• Develop strategic scientific relationships with key partners in the field of Duchenne muscular dystrophy.
• Oversee and manage relationships with all external CRO partners and other medical research vendors.

Required Skills:

• PhD, MD, PharmD, or advanced degree in life sciences/related subject required.
• 10 years of related life sciences experience; 4+ years of experience in evidence generation in the pharmaceutical industry preferred.
• Launch experience strongly preferred.
• Experience developing medical affairs evidence generation strategy.
• Demonstrated history of building and executing successful research initiatives.
• Experience managing CRO partners and other vendors.
• Strong knowledge of regulatory requirements.
• Outstanding cross-departmental and external communication skills.
• Ability to work cross-functionally to achieve strategic outcomes.