Associate Director/Director of Compliance and Operations

Apnimed is a rapidly growing pharmaceutical company working to transform the treatment of sleep apnea based on a simple idea – patients with obstructive sleep apnea (OSA) could benefit from treatment with a safe and effective oral medication dosed once daily at bedtime. Our lead development program, AD109, targets the neurologic control of upper airway muscles to maintain an open airway during sleep. Based in Cambridge, Mass., Apnimed is committed to innovation, as well as state-of-the-art advancements in sleep medicine, which is leading to the development of a portfolio of novel pharmacologic therapies for sleep apnea and related disorders. Of note, the Boston Business Journal has also voted Apnimed as one of the Best Places to Work in 2024 and 2025!

Summary:

We are building Apnimed's compliance program ahead of our first commercial launch, and we are looking for a Director of Compliance to build it with us. This is the first dedicated compliance hire, partnering directly with the Chief Compliance Officer. This role will report to Deputy General Counsel, Chief Compliance & Privacy Officer and has four parts:

• Running the operational side of the compliance program
• Advising Commercial and Medical Affairs early, so compliance shapes launch strategy rather than reacting to it
• Overseeing the controls we are putting in place and making sure they work in practice
• Being the go-to resource for everyday compliance questions across the business.

This is a hands-on role at a company where you will see your work directly affect how we launch. It suits someone who has been through a launch, can move between strategy and execution in the same day, and is known as a business partner who finds the compliant path forward.

Key Job Duties include, but are not limited to:

Compliance operations

• Build and run day-to-day program operations, using the OIG General Compliance Program Guidance and the seven elements of an effective compliance program as the framework.
• Draft, implement, and maintain policies and SOPs covering HCP/HCO interactions, speaker programs, advisory boards, consulting arrangements, meals and transfers of value, sampling, field conduct, and patient support programs.
• Operate the HCP engagement process end to end, including needs assessments, fair market value application, contracting, documentation, and post-engagement reconciliation.
• Own federal Open Payments (Sunshine Act) reporting and state transparency, aggregate spend, and code-of-conduct obligations, including Massachusetts, Vermont, Minnesota, Connecticut, Nevada, New Jersey, California, and DC. Manage the aggregate spend vendor and data validation.
• Run exclusion and debarment screening for employees, HCPs, and vendors.
• Build and deliver compliance training — onboarding, launch-readiness, and role-specific training for field sales, field medical, and market access — and track completion.
• Administer the compliance hotline and support investigations, intake, triage, and documentation.
• Manage compliance vendors (aggregate spend, hotline, screening, training platform, FMV) within budget.

Strategic advisory to Commercial and Medical Affairs

• Serve as the embedded compliance partner to Commercial, Market Access, and Medical Affairs leadership on launch planning, tactics, and go-to-market design.
• Advise on pre-approval activities, including disease-state education, scientific exchange, and payer communications, and make sure launch-readiness work stays within the pre-approval rules.
• Help design and maintain appropriate separation between field medical (MSLs) and commercial teams.
• Advise on speaker program design, advisory boards, congress and exhibit activity, and patient support, hub, and copay programs.
• Review sales incentive compensation plans for compliance risk, and partner with Commercial Operations on field call-plan and targeting governance.
• Serve as the compliance reviewer on the Promotional Review Committee (PRC/MLR), alongside Legal, Medical, and Regulatory.

Controls oversight, monitoring, and auditing

• Own the compliance controls inventory and make sure each control has an owner, is operating, and is documented.
• Design and execute a risk-based monitoring and auditing plan: live speaker program monitoring, field ride-alongs, expense and meal audits, HCP contract file reviews, and transparency data testing.
• Lead the annual compliance risk assessment and track remediation of findings.
• Prepare compliance metrics and reporting for the CCO, executive leadership, and the compliance committee.

Everyday business partner

• Be the first point of contact for day-to-day compliance questions from across the company, giving clear, practical, timely guidance.
• Hold regular office hours and build easy-to-use tools (FAQs, decision trees, quick-reference guides) so colleagues can self-serve on common questions.
• Know when to escalate: route legal interpretation and higher-risk matters to the CCO and Legal.

Education and Experience:

Required

• 8 years of compliance experience in the pharmaceutical or biotech industry, with direct experience supporting commercial and medical affairs functions.
• Experience with at least one U.S. product launch, or building compliance infrastructure for a commercial-stage organization.
• Working knowledge of the federal Anti-Kickback Statute, False Claims Act, FDA promotional and pre-approval rules, Sunshine Act / Open Payments, PDMA, the PhRMA Code, OIG compliance guidance (including the 2020 Special Fraud Alert on Speaker Programs), and state transparency and marketing laws.
• Hands-on operational experience: you have personally run processes such as Open Payments reporting, HCP contracting/FMV, speaker program monitoring, or promotional review, not only advised on them.
• Sound judgment and a practical, business-oriented approach; able to give clear answers and explain the reasoning.
• Comfortable working in a small, fast-moving company without a large support structure.
• Excellent written and verbal communication, including training delivery to field teams.
• Bachelor's degree.

Preferred

• Experience at an emerging or first-launch company.
• Experience in biotech and pharma and knowledgeable with commercial and medical operations, including marketing, sales, patient support, hub, and copay program compliance, and with market access and payer interactions.
• Familiarity with aggregate spend, CRM, and compliance technology platforms.

What Apnimed Offers:

• 401(k) with company match
• Generous time off for vacation
• Generous healthcare benefits
• Flexible working environment
• Motivated and experienced team
• Winner of 2024 Boston Business Journal Best Places to Work

Location and Other Information:

• Apnimed is a publicly licensed company based in Cambridge, MA; we are generally virtual and specific location within the US is not critical.
• We are a small growing Company with an inclusive environment.
• Must be able to travel as necessary.
• Apnimed is an EEO employer committed to an exciting, diverse, and enriching work environment.
• Please visit us at www.apnimed.com to learn more about our work with Obstructive Sleep Apnea.