Sr. Clinical Risk Manager

Job DescriptionWe are seeking a highly experienced Senior Clinical Risk Manager to lead the execution of our Risk-Based Quality Management (RBQM) strategy across a portfolio of complex clinical trials. In this role, you will partner with cross-functional teams, Clinical Research Organizations (CROs), and key stakeholders to proactively identify, assess, and mitigate risks—ensuring high-quality study delivery and compliance with global regulatory requirements.This is a highly visible role that requires strong leadership, strategic thinking, and deep RBQM expertise to support study and program-level success.RBQM Execution & Study DeliveryLead the development and management of study-level risk assessments, including Risk Assessment Categorization Tools (RACTs) and integrated Quality Risk Management Plans (iQRMPs)Maintain risk logs and ensure accurate, real-time tracking of study risksFacilitate periodic risk review meetings and drive proactive risk identification and mitigationProvide expert guidance on site risk levels, study health, and performance trendsDefine and implement study-specific monitoring strategies, including risk-based monitoring approaches such as targeted SDV or centralized monitoringRisk Oversight & ReportingDocument, communicate, and escalate risks to leadership as appropriateTrack, trend, and report Key Risk Indicators (KRIs) to support data-driven decision-makingPartner with internal teams and external vendors to manage risks, mitigations, and issue resolution timelinesEnsure CROs and service providers adhere to RBQM processes and expectationsSupport or lead program-level RBQM activities and escalationsGovernance, Compliance & Continuous ImprovementServe as a subject matter expert (SME) for RBQM across the organizationEnsure adherence to SOPs, work instructions, and regulatory requirementsContribute to ongoing enhancement of RBQM processes and toolsChampion a culture of quality, compliance, and continuous improvementQualificationsRequired QualificationsBachelor’s degree in a scientific or technical discipline (or equivalent experience)8+ years of Clinical Operations or Development experience, including at least 7 years focused on RBQMPrior in-house RBQM experienceExperience operating at the Manager or Senior Manager level within RBQMPreferred Experience & SkillsStrong knowledge of RBQM principles, methodologies, and implementation practicesDeep understanding of global clinical research regulations (e.g., ICH-GCP, 21 CFR Part 11)Experience supporting regulatory inspections and audits related to RBQMProven ability to lead process improvement initiativesStrong collaboration skills with CROs and external partnersExcellent communication, problem-solving, and risk management capabilitiesAdditional InformationDeciphera is committed to fair and equitable compensation practices. The base salary pay range for this role is $157,000 - $215,000. Actual compensation packages will depend on various factors, including, but not limited to depth of experience, education, skillset, overall performance and/or location.​Deciphera believes in providing a competitive compensation and benefits package to all employees. Our base salary is just one component of Deciphera’s competitive total rewards strategy that also includes annual performance bonus, a long-term incentive plan, full range of benefits and other incentive compensation plans (if applicable)Benefits:Competitive salary and annual bonus.Comprehensive benefits package including medical, dental, vision insurance, 401(k) retirement plan with company match, and more.Generous parental leave and family planning benefits.Outstanding culture and opportunities for personal and professional growth.EQUAL EMPLOYMENT OPPORTUNITY INFORMATIONDeciphera is committed to equal employment opportunity and values diversity. To ensure that we comply with reporting requirements, we invite you complete the confidential survey at the end of this application. Providing this information is optional. It will not be accessible or used in the hiring process, and has no effect on your opportunity for employment. This information will also be treated confidentially. We are committed to make all hiring decisions and other employment decisions on a non-discriminatory basis.SummaryType: Full-timeFunction: ScienceExperience level: Mid-Senior LevelIndustry: Pharmaceuticals