Reporting to the VP, Head of Compliance, the Associate Director, Compliance & Ethics provides an opportunity to play a highly visible role in shaping and evolving the Compliance & Ethics program at a commercial-stage biotech. With a strong onsite presence, you will benefit from close, in-person collaboration with cross-functional partners, enabling faster decision-making, real-time problem solving and greater influence across the organization. You will have the opportunity to gain experience across multiple elements of our Compliance & Ethics program. If you are looking to take ownership and make a meaningful impact in a collaborative, patient-driven environment, this role offers opportunity and growth.
Responsibilities (including, but not limited to):
This position will provide support for a broad range of compliance and ethics program areas, including monitoring, auditing, transparency and reporting, and risk assessment.
This role is based in our Lexington, MA office and requires employees to be onsite five days per week.
Monitoring and Auditing
- Drive the development and execution of the Company's annual Compliance & Ethics monitoring and auditing plan, including updating and revising based on new and/or emerging compliance risks.
- Oversee monitoring and auditing activities by Compliance & Ethics team (including both live and desktop activities) to ensure compliance with applicable laws, regulations, and Company policies.
- Track and report on progress of monitoring and auditing activities, including drafting reports, analyzing data, communicating results and supporting data analytics throughout multiple levels of the organization.
Transparency and Reporting
- Act as subject matter expert on transparency, aggregate-spend and reporting requirements.
- Facilitate data collection and generation of transparency reports and subsequent reporting to applicable authorities.
- Lead the development, implementation, and continuous improvement of policies, processes, work instructions and controls, governing spend capture, data validation and reporting.
- Collaborate closely with internal and external stakeholders to track and ensure complete, accurate and timely submissions under applicable laws and regulations.
- Maintain understanding of applicable transparency and reporting laws, regulations and industry codes.
Risk Assessment
- Support compliance and enterprise risk assessments, conduct root cause analyses, risk mitigation planning and execution, and regular risk reviews to ensure effectiveness of Kiniksa's Compliance & Ethics program and Enterprise Risk Management (ERM) program.
- Track and report on risk assessment results, including drafting reports, analyzing data and communicating results to Compliance & Ethics program key stakeholders.
Leadership and Oversight
- Provide leadership in helping Kiniksa maintain and further develop a strong culture of compliance and ethics, including driving personal accountability for compliance and ethics.
- Develop and/or identify new work processes, tools or resources that will have broad applicability throughout the organization; contribute ideas for achieving organizational goals.
Standout Skills for Impact:- Leadership: Proven cross-functional leadership driving alignment and results.
- Influence: Strong ability to build credibility and influence external stakeholders, including scientific and thought leaders.
- Communication: Excellent presentation and communication skills across diverse audiences.
- Execution: Translates strategy into effective, actionable plans and delivers with impact.
Qualifications and Experience: - B.A./B.S. degree or equivalent required.
- 8+ years in compliance, ethics, audit and/or related roles within biotech/pharma.
- Strong experience with transparency and aggregate spend reporting.
- Experience developing and executing compliance and ethics monitoring and auditing plans.
- Strong data analysis and reporting skills.
- Knowledge of applicable healthcare compliance laws, regulations and industry codes.
- Demonstrated attention to detail and high-quality work product.
- Ability to prioritize and work effectively in a fast-paced environment.
- Proficient with Microsoft Office and reporting tools (e.g., Tableau, Smartsheet, Cognos Report, Query Studio).
- Commitment to high ethical and compliance standards.
- Ability to travel up to 20%.
Compensation decisions are based on objective criteria including role responsibilities, experience/qualifications, internal equity, geographic location, and external market benchmarks.
Pay Range
$170,000-$190,000 USD
