Senior Director, Head of Compliance

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:

• Develop, implement, and maintain comprehensive compliance policies, practices, and procedures that align with applicable U.S. pharmaceutical laws, regulations, and industry standards.
• Serve as the primary compliance advisor to the leadership team, providing strategic guidance on regulatory and ethical matters.
• Collaborate with the parent company's compliance team to ensure alignment with global policies and practices.
• Demonstrate excellent judgment, discretion to maintain confidentiality of information, and the highest degree of integrity and professionalism.
• Establish and foster a culture of compliance throughout the organization.

Healthcare Compliance:

• Monitor and interpret federal and state pharmaceutical laws and regulations, advising the company on necessary actions to maintain healthcare compliance.
• Oversee compliance with FDA, Office of Inspector General (OIG), and other regulatory requirements relevant to pharmaceutical operations and marketing practices.
• Oversee processes and procedures related to reporting transfers of value under federal and state transparency laws, including responsibility for accurate completion and timely submission of all relevant reports.
• Collaborate with legal to advise on healthcare compliance matters, including interpretation of Company policies and practices regarding interactions with healthcare professionals and related transparency reporting.
• Maintain awareness of emerging compliance trends and regulatory changes in the rare disease space.

Risk Assessment and Mitigation:

• Develop monitoring, auditing and remediation programs to manage healthcare compliance risks.
• Oversee internal and external audits related to healthcare compliance activities.
• Investigate and address compliance violations, ensuring appropriate corrective actions are implemented.
• Oversee and maintain the compliance hotline and reporting system. Investigate reports of noncompliance and recommend related corrective action plans and disciplinary actions, as necessary.
• Develop and implement key performance indicators (KPIs) to measure the effectiveness of the compliance program.
• Prepare and present regular compliance reports to the leadership team and board of directors.

Training and Education:

• Develop, implement, manage, and deliver healthcare compliance training programs to employees at all levels, fostering a culture of ethical behavior and accountability.
• Ensure that staff understand and adhere to compliance policies, procedures, and reporting obligations.

Policies and Procedures:

• Develop, update, and maintain compliance policies and procedures to reflect changes in regulations, industry standards, and company practices.
• Ensure proper documentation and reporting of compliance activities, including investigations and resolutions.

Collaboration and Liaison:

• Work closely with the Vice President of Legal to ensure consistent integration of legal and compliance strategies.
• Collaborate with other functional leaders, including Commercial, and Medical Affairs, to embed compliance into business processes.
• Prepare periodic compliance activity reports and facilitate proactive communication and socialization of initiatives to ensure a culture of compliance throughout the organization.
• Serve as the primary point of contact for regulatory authorities on compliance-related matters.
• Build and maintain relationships with key stakeholders in the rare disease community to stay informed about patient needs and industry best practices.

Required Skills:

• Bachelor’s degree required; Juris Doctor (JD) degree from an accredited law school strongly preferred.
• Minimum of 12 years of compliance experience in the pharmaceutical or biotechnology industry, with a focus on U.S. regulatory requirements. Exposure to the Rare Disease space is a bonus.
• In-depth knowledge of FDA regulations, OIG guidance, and other federal and state laws impacting the pharmaceutical industry.
• Proven experience in developing and implementing compliance programs.
• Strong leadership and interpersonal skills, with a proven ability to influence and collaborate effectively across all levels, including executive leadership and the board.
• Excellent analytical, problem-solving, and communication skills.
• High integrity with a proactive, team-oriented mindset that fosters trust and collaboration across all levels of the organization.
• Willingness to travel occasionally, as required.