Kiniksapharmaceuticals

Senior Director, Healthcare Compliance

Lexington, MA · Director

Sponsorship not specified$250k-$280kDetected 22 days ago

ComplianceProduct ManagementAuditingProcess ImprovementPatient CareFDA RegulatoryLeadershipCommunication

About the role

Grounded in rigorous science and bold innovation, the company fosters a highly collaborative, patient‑first culture led by accomplished life sciences leaders.
At Kiniksa, talented individuals are trusted and empowered to make a real impact-shaping the future of medicine while improving the lives of patients who need it most.
This role is based in our Lexington, MA office and requires employees to be onsite five days per week.

Define and lead the Compliance & Ethics strategy for the Commercial organization, as well as other key business areas, aligning compliance priorities with Company growth, product lifecycle, and market expansion.
Design and help build scalable compliance processes and procedures to support future product launches and geographic expansion.
Partner with Commercial leadership to design processes and procedures that enable compliance.
Maintain deep expertise in applicable laws and monitor external compliance developments within the pharmaceutical industry
Drive innovation in compliance operations through technology, automation, and process improvement
Together with other Compliance & Ethics team members, lead the development of role-specific, risk-based training and awareness programs that drive behavior change
Experience advising or serving as a compliance business partner to the Commercial organization (e.g., Sales, Marketing, Thought Leader Liaisons).
Experience providing compliance guidance regarding HCP engagements, grants, sponsorships, and patient support programs.
Track record of successfully building or scaling compliance and ethics programs.

10+ years in pharmaceutical/biotech compliance
Strong knowledge of U.S. Anti-Kickback Statute, U.S. False Claims Act, PhRMA Code, OIG guidance, and applicable state regulations.
Excellent communication and prioritization skills, with an ability to work in a collaborative, cross-functional environment.
B.A./B.S. degree required

$250,000 - $280,000 USD
Kiniksa does not accept unsolicited resumes from staffing agencies or search firms. Any resumes submitted without a signed agreement will be considered property of Kiniksa, and no fees will be paid.

Serve as the accountable Compliance & Ethics business partner for Commercial, as well as Medical Affairs, Patient Services, and Patient Advocacy.
Compensation decisions are based on objective criteria including role responsibilities, experience/qualifications, internal equity, geographic location, and external market benchmarks.
decisions are based on objective criteria including role responsibilities, experience/qualifications, internal equity, geographic location, and external market benchmarks.

This listing is sourced directly from Kiniksapharmaceuticals's careers page and normalized into a canonical job model.