Kiniksa Pharmaceuticals is a commercial‑stage biopharmaceutical company developing and commercializing novel therapies for diseases with unmet need, with a focus on cardiovascular indications. With deep expertise in immunology and inflammation, Kiniksa is advancing a growing portfolio of approved and investigational medicines, anchored by its lead product, ARCALYST®, the first and only FDA‑approved therapy for recurrent pericarditis. 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.
The CTL at CSSE Senior Manager level is responsible for site-facing engagement and operational support for assigned studies, regions, or priority sites. This role focuses on building strong relationships with investigative sites, identifying barriers to screening and enrollment, supporting protocol and operational education, ensuring contemporaneous and accurate data entry, and escalating site-level risks that may impact study execution, participant retention, data quality, or documentation readiness.
The Senior Manager CTL is expected to work independently with assigned sites while partnering closely with Clinical Operations study teams, CRO personnel, Medical Affairs, Patient Advocacy, and other cross-functional partners. The role expands beyond recruitment to include sustained site engagement, operational intelligence, issue identification, risk mitigation, and contribution to continuous improvement.
Responsibilities (including, but not limited to):
Site Oversight
- Build and maintain productive relationships with Principal Investigators, study coordinators, research nurses, site managers, and other relevant site personnel, and serve as a sponsor representative and primary site engagement contact for assigned sites.
- Gather site-level insight on patient availability, recruitment pathways, operational readiness, competing studies, site capacity, and prior performance to support investigator selection during feasibility.
- Provide protocol and operational training/education to sites, including eligibility criteria, visit flow, study procedures, recruitment pathways, and operational expectations, to ensure adherence to the study protocol and clear understanding of overall operational setup of the study.
- Support recruitment and study participant retention initiatives, including site-specific recruitment plans, community/patient pathway insights, participant retention planning, visit readiness reminders, and barrier resolution.
- Monitor assigned site performance against agreed KPIs, screening activity, screen failure trends, enrollment performance, data cleaning and quality, documentation risk, and action-item closure.
- Track and enable contemporaneous data entry and completeness.
CRO Oversight
- Oversee CRO Clinical Research Associates (CRAs) through assessment of performance, review of trends and KPIs, review of CVs of CRA before assignment, training of CRAs, etc.
- Attend qualification, initiation, interim, engagement, or closeout visits, either remotely or in person, as appropriate to oversee CRA performance.
- Review CRA monitoring visit reports for assigned sites.
Study Team Collaboration
- Support sponsor oversight by identifying and escalating risks to participant safety, data reliability, protocol compliance, and documentation completeness.
- Support a risk-proportionate approach to trial conduct consistent with ICH E6(R3), including quality-by-design, operational feasibility, and avoidance of unnecessary site or participant burden.
- Identify and escalate operational barriers at the site level to the relevant study team members.
- Escalate issues related to data quality, protocol deviations, visit compliance, essential documents, training records, delegation logs, and TMF readiness to the Clinical Operations study team.
- Collaborate with Patient Advocacy to incorporate patient pathway insights and community considerations into recruitment and retention efforts.
- Contribute to end-of-study lessons learned, recurring barrier analysis, site feedback, and best-practice sharing.
Standout Skills:
- High-energy site partnership mindset: bring enthusiasm, responsiveness, and a genuine commitment to helping sites succeed, creating strong investigator and coordinator engagement throughout the study lifecycle.
- Relationship building and influence without authority: establish trust quickly, foster collaboration, and effectively influence site personnel, CRO partners, and internal stakeholders to drive study objectives and resolve challenges.
- Proactive ownership and accountability: anticipate issues before they become barriers, follow through on commitments, and take initiative to advance site performance and study execution.
- Resilience, agility and focus on solutions: thrive in a dynamic environment, adapt to changing priorities, and approach operational challenges with creativity, persistence, and a focus on outcomes.
- Exceptional communication and stakeholder engagement: communicate with clarity, credibility, and professionalism, tailoring messages to diverse audiences while maintaining strong alignment across sites and cross-functional teams.
Qualifications and Experience:
- Bachelor’s degree in life science, health science, or related field required; nursing or advanced degree is preferred.
- 5 years’ hands-on clinical trial execution experience.
- Prior study coordinator, CRA or trial recruitment specialist experience strongly preferred.
- Demonstrated ability to build effective relationships with clinical research sites.
- Strong understanding of clinical trial conduct, site operations, GCP, protocol adherence, informed consent process boundaries, and sponsor/CRO/site roles.
- Strong communication, presentation, organization, tracking, and issue-escalation skills.
- Ability to travel frequently, potentially up to approximately 75%, depending on study and regional needs, consistent with the original CTL role expectation.
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
Kiniksa is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, transgender status, age, genetics, national origin, protected veteran status, or disability status, or any other legally protected category. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
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.
