Senior Director Compliance

Job Purpose

The Senior Director Compliance will serve as MoonLakes senior internal compliance leader and the day-to-day owner of the United States compliance program. This is a build role rather than a maintenance role. MoonLake has no approved product currently on the market and the successful candidate will be designing and implementing a scalable risk-based compliance framework policies processes forms tools training monitoring and transparency reporting and embedding them in a lean and fast-moving organization before the first commercial interaction occurs.
The role will lead and operationalize MoonLakes compliance framework across its United States operations and where relevant its European and Swiss activities. Key areas of responsibility include US healthcare fraud and abuse laws including the Federal Anti-Kickback Statute and the False Claims Act; the Federal Food Drug and Cosmetic Act and FDA advertising and promotion requirements including the restrictions that apply to a company with no approved product; federal and state transparency and aggregate spend reporting; federal exclusion and debarment screening; the United States Foreign Corrupt Practices Act; the EFPIA Disclosure Code and applicable national codes to the extent MoonLakes activities have European reach; the revised Swiss Federal Act on Data Protection and the EU General Data Protection Regulation as they apply to MoonLakes addition the role will champion MoonLakes Code of Conduct and compliance policies translating regulatory requirements into practical risk-based controls that support the Companys growth launch readiness and culture of integrity.
Consistent with the OIGs 2003 Compliance Program Guidance for Pharmaceutical Manufacturers and the OIGs 2023 General Compliance Program Guidance the successful candidate will operationalize and continuously improve an effective program built around the seven elements scaled appropriately for a launch-stage company of MoonLakes size geographic reach and risk profile.
MoonLake currently receives compliance leadership on a fractional basis. The successful candidate will work alongside that resource during onboarding will assume day-to-day ownership of the program and is expected to become the companys permanent internal compliance lead.

Key Accountabilities

Program build-out and governance

1. Lead the implementation own the execution and continuous improvement of MoonLakes United States compliance program including the Code of Conduct the compliance policy suite and supporting standard operating procedures.
2. Complete and assume ownership of the compliance policy build-out already in progress including the non-promotional activities advisory board HCP engagement patient advocacy and patient interaction payer interaction meals and hospitality HCP travel and expense medical legal and regulatory review and speaker program policies together with the Needs Assessment Form the Fair Market Value Rate Matrix and tiering tool and the HCP master agreement and activity statements of work.
3. Deliver the promotional and commercial policy set ahead of approval and launch ensuring organizational readiness across promotion promotional speaker programs and the speaker bureau congress and exhibits personal services samples field interactions social media managed markets and contracting and copay and patient support programs.
4. Support the Compliance Committee. Develop agendas document deliberations and prepare quarterly reporting to executive leadership and to the Board on program effectiveness risks identified and remediation status.
5. Own a documented policy lifecycle including version control a periodic review cadence named policy owners and a change log and maintain consistent defined terms and cross references across the policy suite.
6. Establish and maintain MoonLakes compliance with state comprehensive compliance program statutes including California Health and Safety Code sections 119400 to 119402 and prepare the annual written declarations of compliance.

Pre-approval and launch readiness

1. Own the pre-approval compliance posture. Ensure that no communication represents an investigational product as safe or effective that disease-state and scientific exchange activity remains non-promotional and that the Companys pre-launch activities do not constitute premature commercialization
2. Advise on and govern the deployment of a pre-approval field organization including the conduct guardrails that apply the boundary between permitted disease-state education and impermissible promotion escalation to Medical Information and the transition of personnel into commercial roles upon approval.
3. Govern pre-approval information exchange with payers and population health decision makers and ensure that communications remain factual balanced and within the applicable framework.
4. Build launch readiness against a defined timeline so that policies training monitoring aggregate spend capture and transparency reporting are operational before the first commercial interaction rather than after it.
5. Advise on patient support program design including bridge and patient assistance program structures copay assistance free goods and hub and specialty pharmacy arrangements and the government payer considerations that constrain each.

Interactions with healthcare professionals and fraud and abuse compliance

1. Oversee compliance with the Federal Anti-Kickback Statute the False Claims Act and applicable OIG guidance including the 2020 Special Fraud Alert on speaker programs governing all interactions with healthcare professionals.
2. Own the fair market value framework including the tiered rate matrix the tiering tool and its criteria written agreements needs assessments and engagement caps for speaker consultant and advisory board arrangements.
3. Maintain a tiering methodology that weights community and academic practice equally so that expertise resident in private and community practice is recognized and compensated on a defensible basis.
4. Require that transfers of value be pre-approved through Compliance maintaining clear separation from commercial decision-making
5. Maintain meal travel and hospitality limits aligned to internal caps and to the strictest applicable state requirements and enforce the prohibition on company-funded alcohol at programs.
6. Monitor state gift ban marketing limitation and aggregate spend laws including those of California Connecticut Massachusetts Minnesota Nevada and Vermont and manage state representative licensure and registration obligations.

Material review advertising and promotion

1. Serve as the standing Compliance member of the medical legal and regulatory review committee and operate the tiered risk-based review process its service levels and the material lifecycle from approval through expiry and withdrawal.
2. Ensure that promotional and non-promotional materials are reviewed against FDA OIG and FTC requirements and where applicable national code requirements.
3. Require mandatory re-review of materials upon labeling safety or data updates and maintain a defined withdrawal and recall procedure.
4. Own the compliance perspective on the selection and configuration of material review technology including any automated or artificial-intelligence-assisted review and enforce the requirement that a named human reviewer records every approval.

Risk assessment monitoring and auditing

1. Conduct and lead an annual enterprise compliance risk assessment covering United States operations and any activity with European or Swiss reach and translate the results into a prioritized workplan.
2. Build and execute a risk-based monitoring plan covering field activity speaker and disease-state programs advisory boards patient support activity grants and sponsorships and third-party intermediaries.
3. Establish the monitoring program ahead of launch and the audit program thereafter including sampling methodology evidence retention and documented closure of findings.
4. Document findings agreed corrective and preventive actions and effectiveness verification and track remediation to completion against defined timelines.

Transparency reporting and aggregate spend

1. Capture transfers of value from the first engagement so that MoonLakes records are launch-ready rather than reconstructed.
2. Select and implement the aggregate spend and transparency reporting solution and own the vendor relationship and the underlying processes.
3. Own the end-to-end Federal Open Payments process for all covered recipients including annual data collection validation dispute resolution submission to CMS and recordkeeping and own all state aggregate spend filings.
4. Coordinate European transparency disclosure under the EFPIA Disclosure Code and applicable national codes to the extent MoonLakes activities require it.

Screening third parties and anti-corruption

1. Maintain monthly screening of employees contractors vendors healthcare professionals and speakers against the OIG List of Excluded Individuals and Entities the GSA System for Award Management and the FDA Debarment List with documented evidence and defined remediation procedures.
2. Maintain the third-party intermediary program including risk-based due diligence written approvals contractual anti-corruption undertakings training and periodic re-assessment.
3. Maintain and enforce the anti-bribery and anti-corruption program under the United States Foreign Corrupt Practices Act and applicable Swiss and European requirements.

Training investigations and reporting channels

1. Design and deliver risk-based compliance training including new hire annual refresher role-specific and event-driven training and track completion effectiveness and signed attestations.
2. Stand up and maintain the training record system and report completion to leadership with an escalation path for non-completion.
3. Implement and own the confidential and anonymous compliance reporting hotline and other reporting channels operationalize non-retaliation and analyze and report on report trends.
4. Lead investigations of compliance allegations coordinate with Legal HR People & Culture and outside counsel as appropriate. Document findings root causes and corrective actions and apply consistent and well-publicized disciplinary standards in accordance with MoonLakes governance framework and internal policies.
5. Serve as a point of contact for the FDA OIG DOJ CMS and state regulators on compliance matters and coordinate response strategy with Legal and outside counsel.

Data protection interface

1. Partner with Legal Information Technology and the Data Protection Officer on the compliance-adjacent aspects of data protection including patient authorization the handling of protected health information by field and patient-facing personnel and the data flows arising from hub specialty pharmacy copay and data aggregation arrangements.
2. Ensure that the United States data protection posture is built for United States requirements and coordinate with the Swiss and European privacy workstream rather than importing requirements that do not apply.

Culture

1. Promote a speak-up culture across every function and act as a visible approachable and practical business partner. Compliance at MoonLake is a governance function that identifies analyzes and mitigates risk; it is not an approving function for business decisions and it is not a check-the-box exercise.

Your profile

Education:

• Bachelors degree in life sciences business law public health or a related field. An advanced degree such as a JD MBA MPH or PharmD is preferred.
• Certified in Healthcare Compliance (CHC) or another Compliance Certification Board credential (preferred).

Experience:
Required

• A minimum of ten years of progressive healthcare compliance experience in the pharmaceutical biotechnology or medical device industry for appointment at the Senior Director level or a minimum of eight years for appointment at the Director level in each case including at least three years in a leadership or program ownership role.

Preferred

• Prior commercial launch experience at a company taking its first product to market in the United States and direct experience on a material review committee.
• Experience in immunology and inflammation dermatology rheumatology or another specialty rare or orphan therapeutic area.
• Experience supporting a company with both United States and European or Swiss operations including working knowledge of the EFPIA Disclosure Code applicable national codes and the revised Swiss Federal Act on Data Protection and the EU General Data Protection Regulation.
• Direct experience standing up an aggregate spend and transparency reporting capability including vendor selection and first-cycle Open Payments submission.
• Experience advising on pre-approval field deployment pre-approval information exchange with payers and patient support program design.
• Working familiarity with material review monitoring screening aggregate spend and learning management platforms and experience governing analytics or artificial-intelligence-assisted monitoring in a regulated setting.
• A demonstrated track record of building compliance program elements from a standing start rather than only operating an established program including risk assessment monitoring training investigations hotline management exclusion screening and transparency reporting.

Skills/knowledge/behavioural competencies:

• Demonstrated working knowledge of the Federal Anti-Kickback Statute the False Claims Act the Federal Food Drug and Cosmetic Act the OIG Compliance Program Guidance for Pharmaceutical Manufacturers (2003) and General Compliance Program Guidance (2023) the Physician Payments Sunshine Act the PhRMA Code applicable state transparency and gift ban laws and the United States Foreign Corrupt Practices Act.
• Strong written and verbal communication skills including the ability to translate complex regulatory requirements into clear and practical guidance for business teams.
• Excellent analytical organizational and project management skills with the ability to manage competing priorities against launch deadlines.
• Comfort operating with ambiguity and without established infrastructure and the willingness to draft build and administer as well as advise.
• Demonstrated independence and integrity and comfort raising difficult issues constructively.
• Proficiency with compliance technology across training monitoring screening aggregate spend and contract lifecycle management and with Microsoft 365.
• The ability to work effectively across Legal Regulatory Medical Affairs Commercial Market Access Finance Information Technology and People and across time zones.
• Sound judgment demonstrated ability to influence senior leadership and the integrity to raise concerns through the established chain of escalation.

Working conditions and travel:

• Office based with hybrid flexibility. Remote or hybrid arrangements may be considered subject to the candidates ability to travel regularly to Miami and other MoonLake locations. Periodic domestic travel of approximately 30 percent is expected for field ride-alongs program and congress monitoring audits training and business meetings. Periodic international travel to MoonLakes Swiss headquarters in Zug its European hubs in the UK and Portugal and to European congresses is required.

Why us

An exciting job opportunity awaits!

MoonLake is a dynamic and innovative company pushing the boundaries of possibility and we are looking for passionate individuals to join our stellar team.

What we offer:

Learning Environment: An opportunity to learn and grow alongside experienced professionals in a supportive and innovative biotech environment.

Impactful Work: Contribute to ground-breaking projects that have the potential to transform global healthcare.

Flexibility and Balance: Work remotely/hybrid enjoying a healthy work-life balance while making meaningful contributions to our team.

Career Growth: A clear path for career progression with the chance to take on more responsibilities as you develop your skills.

Our Core Values

We look for potential MoonLakers that embody our three core values that drive our pursuit of excellence:

We do Stellar Science: We aspire to create novel therapies that elevate treatment horizons with innovative science and high quality always.

We go beyond: We aspire to be positively disruptive in our field and bold in the way we challenge the norms and each other.

We unlock value: We aspire to create long-term value for investors and communities.

About us

MoonLake Immunotherapeutics is a clinical-stage biopharmaceutical company unlocking the potential of sonelokimab a novel investigational Nanobody for the treatment of the inflammatory disease to revolutionize outcomes for patients.

We continue to make significant progress in our Global Clinical Development Programs. The companys focus is on inflammatory diseases with a major unmet need including hidradenitis suppurativa and psoriatic arthritis conditions affecting millions of people worldwide with a large need for improved treatment options. MoonLake was founded in 2021 and is headquarted in Zug with hubs in Cambridge & Porto.

Further information is available at

Required Experience:

Exec