Title: Associate Director, Medical Operations
Location: Concord, MA, Remote
Reporting to: Director, Medical Operations
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 play a pivotal role in supporting the Medical Affairs team by overseeing and managing various operational aspects. This position involves assisting with strategic planning, coordination, and execution of medical operations to ensure the effective delivery of medical and scientific information. The role requires collaboration with cross-functional teams to support Field Medical, grants and sponsorship requests, data management within CRM portal, vendor requisition, compliance transparency reporting and other medical activities.
Primary Responsibilities:
- Operational Management: Oversee the day-to-day operations of the Medical Affairs team, ensuring efficient workflow and adherence to timelines with the ability to think outside the box, ability to pivot and work in a fast-paced small biotech environment.
- Strategic Planning: Assist with the development of operational strategies to support the goals of the Medical Affairs team.
- Project Coordination: Manage and coordinate projects related to grants and sponsorship, CRM activities, vendor requisition and compliance transparency reporting (Advisory boards, Disease education programs, HCP Consulting agreements).
- Compliance: Ensure all activities comply with industry standards, regulatory requirements, and company policies.
- Budget Management: Assist with budget planning and management for medical operations activities.
- Stakeholder Collaboration: Work closely with internal and external stakeholders, including evidence generation, legal/compliance, finance, IT and commercial teams, to support medical initiatives.
- Data Management: Oversee the collection, analysis, and reporting of CRM data to support decision-making and strategic planning.
- Quality Improvement: Identify areas for process improvement and implement best practices to enhance operational efficiency.
- Operational effectiveness: Any other projects defined by the Director, Medical Operations.
Required Skills:
- Minimum of 5-7 years of experience in medical operations or a related field within the biotech or pharmaceutical industry.
- Experience within a growing company, start-up experience preferred.
- Strong team player and ability to work cross functionally.
- Education: Degree in life sciences, medical, or related field.
- Strong leadership, project management, and communication skills.
- Proficiency in data analysis and familiarity with compliance and regulatory requirements.
This role offers an exciting opportunity to be a key player in a growing organization dedicated to making a significant impact in rare disease treatment.
