Sr. Clinical Risk Manager

Company Description

Job Description

We 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 Delivery

• Lead 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 risks
• Facilitate periodic risk review meetings and drive proactive risk identification and mitigation
• Provide expert guidance on site risk levels, study health, and performance trends
• Define and implement study-specific monitoring strategies, including risk-based monitoring approaches such as targeted SDV or centralized monitoring

Risk Oversight & Reporting

• Document, communicate, and escalate risks to leadership as appropriate
• Track, trend, and report Key Risk Indicators (KRIs) to support data-driven decision-making
• Partner with internal teams and external vendors to manage risks, mitigations, and issue resolution timelines
• Ensure CROs and service providers adhere to RBQM processes and expectations
• Support or lead program-level RBQM activities and escalations

Governance, Compliance & Continuous Improvement

• Serve as a subject matter expert (SME) for RBQM across the organization
• Ensure adherence to SOPs, work instructions, and regulatory requirements
• Contribute to ongoing enhancement of RBQM processes and tools
• Champion a culture of quality, compliance, and continuous improvement

Qualifications

Required Qualifications

• Bachelor’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 RBQM
• Prior in-house RBQM experience
• Experience operating at the Manager or Senior Manager level within RBQM

Preferred Experience & Skills

• Strong knowledge of RBQM principles, methodologies, and implementation practices
• Deep understanding of global clinical research regulations (e.g., ICH-GCP, 21 CFR Part 11)
• Experience supporting regulatory inspections and audits related to RBQM
• Proven ability to lead process improvement initiatives
• Strong collaboration skills with CROs and external partners
• Excellent communication, problem-solving, and risk management capabilities

Additional Information

Deciphera 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 INFORMATION

Deciphera 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.