Job Details

Our client, a small and growing biotech company focused on rare diseases, is seeking a Senior Director, Compliance Officer to lead and enhance their corporate compliance program. This is a key leadership role responsible for ensuring adherence to healthcare regulations and ethical standards, particularly in commercial and medical affairs activities.

Key Responsibilities:

• Develop, implement, and oversee the company's corporate compliance program, ensuring adherence to all applicable healthcare laws and regulations.
• Provide strategic guidance on compliance matters related to sales, marketing, and medical affairs functions.
• Conduct compliance risk assessments and develop mitigation strategies tailored to a small biotech environment.
• Lead compliance training programs for employees across departments, fostering a strong culture of ethical conduct.
• Collaborate with leadership, including Legal, Medical, and Commercial teams, to ensure business activities align with regulatory expectations.
• Monitor and assess industry trends, regulatory updates, and enforcement actions to continuously refine compliance policies and procedures.
• Manage internal investigations and ensure appropriate corrective actions are implemented.
• Serve as a key liaison with regulatory agencies as needed.

Qualifications:

• Juris Doctor (JD) required.
• Minimum of 8+ years of experience in compliance roles within biotech, pharmaceutical, or life sciences companies.
• Small biotech experience is a must.
• Strong knowledge of healthcare compliance laws and regulations, including the Anti-Kickback Statute, False Claims Act, OIG guidance, and PhRMA Code.
• Experience working with compliance issues related to sales, marketing, and medical affairs functions.
• Proven ability to build and scale compliance programs in a growing organization.
• Excellent communication and leadership skills, with the ability to influence stakeholders at all levels.

This is a fantastic opportunity to join a mission-driven biotech company at a pivotal stage of growth. If you have the expertise and passion for leading compliance in a dynamic environment, we'd love to hear from you.