Director, Compliance Operations at Acadia Pharmaceuticals

Foster City, California, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Biopharmaceutical, PharmaceuticalIndustries

Requirements

Bachelor’s degree required; advanced degree preferred
Minimum 7-10 years of US healthcare compliance experience in a biotech/pharma organization
Demonstrated operational compliance expertise, including hands-on experience with transparency reporting, auditing/monitoring and training
Familiarity with state and federal licensing and registration requirements
Experienced in the development, initiation, maintenance, and enforcement of policies and procedures for the operation of a Compliance Program
Demonstrated collaborations working with senior business leaders, attorneys, law enforcement professionals, and regulators
Experience in supporting investigations and managing the investigative process
Rare disease commercial launch experience preferred but not required
Systems implementation/oversight experience preferred
Excellent interpersonal skills, ability to develop important relationships with key stakeholders; a solutions-oriented collaborator
Strong knowledge of relevant regulations and related obligations
Good conflict management and negotiation skills
Excellent organizational, communication and leadership skills
Ability to work independently, and analyze complex issues to develop relevant and realistic plans, programs and recommendations
Strong written, verbal, and presentation skills
Willingness to embrace and champion Company core values
Ability to travel on occasion when necessary

Responsibilities

Lead and manage all aspects of federal and state transparency (Sunshine Act/Open Payments and similar state requirements) and aggregate spend reporting requirements
Monitor and analyze data for trends, anomalies and compliance gaps
Manage ongoing development and execution of Mirum’s risk-based auditing and monitoring program to ensure compliance with applicable laws, regulations and company policies
Work with third-party vendors and internal stakeholders to ensure compliance with state licensing, registration and renewal requirements
Manage continual development and implementation of Mirum’s compliance policies
Champion Company culture in which employees view compliance as aligned with core values and regard it as a key objective in business decisions and process development
Partner with legal, regulatory, finance, quality and other departments to support compliance-related initiatives and resolve operational compliance issues
Assist with ongoing management of training curriculum and healthcare compliance training as needed
Assist with investigations regarding matters of observed, reported or suspected non-compliance and collaborate with functional heads as needed toward implementing necessary corrective actions
Support Privacy initiatives for HIPAA and GDPR compliance as needed
Represent Mirum in industry compliance forums
Participate in ride-long monitoring activities as needed

Skills

Key technologies and capabilities for this role

Sunshine ActOpen PaymentsAggregate Spend ReportingRisk-Based AuditingCompliance MonitoringState LicensingCompliance PoliciesHealthcare Compliance TrainingInvestigationsData Analysis

Questions & Answers

Common questions about this position

What experience is required for the Director, Compliance Operations role?

A Bachelor’s degree is required with an advanced degree preferred, plus a minimum of 7-10 years of US healthcare compliance experience in a biotech/pharma organization. Key expertise includes transparency reporting, auditing/monitoring, training, state and federal licensing, policy development, collaborations with senior leaders and regulators, and supporting investigations. Rare disease commercial launch experience is preferred.

What does the company culture emphasize for this role?

The company embodies values of care, be real, get it done, and have fun, seriously, and seeks individuals who share these. The role involves championing a culture where employees view compliance as aligned with core values and a key objective in business decisions.

Is the salary or compensation specified for this position?

This information is not specified in the job description.

What is the work location or remote policy for this role?

This information is not specified in the job description.

What makes a strong candidate for this Director, Compliance Operations position?

Strong candidates will have 7-10 years of US healthcare compliance experience in biotech/pharma, hands-on expertise in transparency reporting, auditing, monitoring, training, and policy development, plus experience collaborating with senior leaders, regulators, and supporting investigations. Rare disease commercial launch experience and an advanced degree are preferred.

Acadia Pharmaceuticals

Develops therapies for neurological disorders

About Acadia Pharmaceuticals

Acadia Pharmaceuticals develops therapies for neurological disorders, focusing on conditions like Parkinson's disease, schizophrenia, and Rett syndrome. The company conducts extensive research and clinical trials to create drugs that are safe and effective, seeking approval from regulatory bodies like the FDA before bringing them to market. Acadia differentiates itself by targeting areas with significant unmet medical needs, ensuring that their products address critical health challenges. Their goal is to improve the quality of life for patients suffering from these disorders while also promoting diversity, equity, and inclusion within their operations.

Dallas, TexasHeadquarters

1993Year Founded

$813.4MTotal Funding

ACQUISITIONCompany Stage

Biotechnology, HealthcareIndustries

501-1,000Employees

Benefits

Health Insurance

Dental Insurance

Vision Insurance

401(k) Retirement Plan

401(k) Company Match

Employee Stock Purchase Plan

Paid Vacation

Paid Holidays

Paid Sick Leave

Paid Parental Leave

Tuition Reimbursement

Risks

Increased competition in CNS drug market may impact Acadia's market share.

Potential clinical trial delays could affect drug approval timelines.

Dependence on partnerships poses risks if collaborations face challenges or dissolve.

Differentiation

Acadia focuses on CNS disorders with unmet medical needs, like Parkinson's and Rett syndrome.

The company has a strong R&D foundation, developing innovative small molecule drugs.

Acadia's strategic partnerships enhance its research capabilities and market reach.

Upsides

Acadia's collaboration with Saniona expands its portfolio with SAN711 for neurological disorders.

Health Canada's approval of Daybue boosts Acadia's presence in the Canadian market.

The rise of personalized medicine aligns with Acadia's targeted therapy approach.

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