Careers

Director, Compliance

Company Overview:
Alpha Cognition is a cutting-edge pharmaceutical company dedicated to transforming the lives of individuals with Alzheimer’s disease and other cognitive disorders. As we prepare to launch ZUNVEYL, an FDA-approved treatment for mild to moderate Alzheimer's disease, we are seeking a highly experienced Director of Compliance to ensure our commercial and sales activities align with legal and regulatory standards while supporting our mission to lead in the long-term care market.

• Job Summary:
  The Director of Compliance will oversee all aspects of compliance within the organization, with a primary focus on ensuring our sales and marketing operations adhere to applicable laws, regulations, and industry standards. This leader will also provide guidance on broader compliance matters, including research, manufacturing, distribution, and corporate governance, ensuring Alpha Cognition operates with integrity and transparency.

Key Responsibilities:

Sales and Commercial Compliance:

• Develop, implement, and manage compliance programs to support sales and marketing activities, ensuring adherence to FDA, FTC, OIG, and PhRMA guidelines.
• Provide training to the sales force on compliant promotional practices, including interactions with healthcare professionals (HCPs) and payers.
• Collaborate with commercial leadership to ensure sales strategies align with regulatory requirements.
• Review and approve promotional materials, sales scripts, and other commercial content for compliance with regulations.
• Monitor field activities, including speaker programs, sales calls, and incentive programs, to identify and address potential compliance risks.
• Oversee the management and monitoring of aggregate spend reporting requirements under the Sunshine Act.

Broader Compliance Oversight:

• Ensure compliance with Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and other relevant regulatory requirements across the organization.
• Maintain policies and procedures to comply with anti-kickback statutes, False Claims Act, and other federal and state laws.
• Manage internal audits, risk assessments, and compliance investigations.
• Partner with legal counsel to address any government inquiries or investigations.
• Stay updated on changes to healthcare laws and regulations and advise leadership on potential impacts.

Leadership and Collaboration:

• Serve as the compliance advisor to senior management, providing regular updates on compliance risks, trends, and activities.
• Build a culture of compliance throughout the organization by fostering awareness and encouraging ethical behavior.
• Act as the primary liaison with external regulatory bodies and ensure timely and accurate reporting of compliance matters.

Qualifications:

• Education: Bachelor’s degree required; advanced degree (JD, MBA, or equivalent) preferred.
• Experience: Minimum of 8 years of experience in pharmaceutical compliance, with a strong focus on sales and marketing activities.
• Thorough knowledge of FDA regulations, OIG guidance, PhRMA Code, and other relevant healthcare compliance standards.
• Proven experience in managing compliance programs for pharmaceutical sales teams, including training, monitoring, and investigations.
• Strong understanding of the pharmaceutical industry, particularly long-term care or Alzheimer’s disease markets, is a plus.

Skills and Competencies:

• Exceptional communication and interpersonal skills to train, guide, and influence cross-functional teams.
• Analytical mindset with the ability to identify risks and develop actionable solutions.
• Strong leadership and project management skills with the ability to manage multiple priorities effectively.
• Integrity and discretion in handling sensitive compliance matters.

The anticipated salary range for this role is $165,000 - $200,000. We encourage candidates of all levels to apply as there may be flexibility on final job title and responsibilities. The salary offer will be based on a variety of factors, including experience, qualifications, internal equity and location. We offer a competitive employment package that includes bonus, equity and a benefits package.

Why Join Alpha Cognition?
At Alpha Cognition, you’ll have the opportunity to make a meaningful impact on patients’ lives while working in a dynamic and collaborative environment. Join us as we revolutionize the Alzheimer’s care landscape with innovative treatments and a commitment to excellence in compliance and patient care.