About TrialSpark
On a mission to bring new treatments to patients faster and more efficiently
Founded in 2016, TrialSpark is a tech-driven Pharma company differentiated by radically more efficient drug development. TrialSpark has built a technology platform that optimizes all aspects of clinical drug development, enabling more efficient trial design, faster trial completion, and higher quality trial data.
The company acquires clinical-stage drugs from pharmaceutical and biotech companies and develops them faster, unlocking greater value per program and accelerating access to new treatments for patients. TrialSpark's current therapeutic areas of focus include rheumatology, dermatology, CNS, and cardiometabolic diseases.
About the Position
As the first dedicated Compliance role, you will be the founding member of the discrete Compliance team and will lead TrialSpark's compliance program by centralizing, bolstering, and implementing Compliance initiatives as we progress through drug development and beyond as a pharma company. This promises to be a complex and exciting opportunity to build a critical piece of a rapidly growing organization, alongside like-minded individuals working toward a better clinical trial.
Reporting into the Legal department, this role will have the support and resources of the larger Legal org, but will be expected to act independently in building a distinct function with its own identity and presence within the company. As in all areas of the business, we do not believe in one size fits all approaches; even if we do land on an existing best practice, we will want to know it's the best way to get the job done first through your analysis and judgment.
Responsibilities

• Design, implement, oversee, and continuously improve company compliance program consistent with OIG guidance
• Create practical systems for monitoring compliance with applicable requirements (including internal company policies) across the company
• Compile applicable tracking requirements, such as physician transfer of value, and establish/run the workflows for tracking and submitting (including in anticipation of requirements not yet applicable to TrialSpark)
• Conduct periodic risk assessments, audits, and internal reviews
• Foster a culture of compliance through company communications, materials, and trainings across the organization
• Liaise with regulatory bodies as needed
• Enhance and publicize compliance communication channels
• Lead Compliance Committee
• Maintain and ideate on corporate insurance policies as a component of risk management
• Stay up to date on compliance and enforcement news and developments
• Partner with key stakeholders to ensure appropriate controls and processes are built into departmental operations
• Coordinate with separate Quality Assurance and Regulatory Affairs teams

About You

• 8+ years life sciences compliance experience with a focus on pharmaceutical/biotech industry
• Deep knowledge of FWA, transparency reporting, FDCA, Anti-kickback, Federal False Claims Act, PhRMA Code, local equivalents, etc.
• Deep knowledge of and interest in international Privacy laws as a robust component of our compliance program
• Able to take a dynamic approach to building compliance from scratch as we grow and requirements become newly applicable.
• An operations mindset to craft a scalable and highly actionable Compliance Program
• Interpersonal ability and presence to maximize individual compliance cross-functionally and at all levels

We offer competitive compensation because we want to hire the best people and reward them for their contributions to our mission. We pay all employees competitively relative to the New York City market, regardless of their location. In compliance with NYC's pay transparency law and in pursuit of pay equity and fairness, we publish salary ranges for all open roles at TrialSpark. The target salary range for this role is $195,000 - $245,000.
On top of base salary, we also offer equity, generous perks, location flexibility, and comprehensive benefits - learn more about them and our compensation philosophy here .
If this range doesn't match your expectations, please still apply because we may have something else for you.
You will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.