Associate Director, Clinical Risk Management and Process Improvement

Insmed Incorporated

15d • Remote

About The Position

At Insmed, every moment and every patient counts — and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you’ll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person’s contributions to meaningful progress. That commitment has earned us recognition as Science magazine’s No. 1 Top Employer for five consecutive years, certification as a Great Place to Work® in the U.S., and a place on The Sunday Times Best Places to Work list in the UK. For patients, for each other, and for the future of science, we’re in. Are you? About the Role: We’re looking for an Associate Director, Clinical Risk Management and Process Improvement on the Clinical Operations / Business Operations team to help us expand what’s possible for patients with serious diseases. Reporting to the Director, Clinical Process, Excellence, Training & Compliance you’ll be a member of the Clinical Business Operations group within Development Operations. This role is responsible for using a data-driven approach (Risk-Based Quality Management - RBQM) to guide and support the proactive identification, assessment, and mitigation of risks within clinical studies to ensure subject safety and data integrity. This role is remote and drives continuous improvement by analyzing clinical study processes, identifying bottlenecks, and implementing solutions to enhance operational efficiency.

Requirements

• You have a Bachelor’s degree (Master’s degree preferred) with 8+ years of experience with Phase 1-3 clinical study operations with a focus on risk management and quality assurance or process improvement.
• A deep understanding of ICH-GCP, regulatory (e.g., FDA, EMA, PDMA) requirements, and experience with RBQM methodologies
• At least 2 years of process improvement experience with demonstrated ability to manage process improvement projects, including developing project timelines, coordinating with teams, and ensuring effective execution, creating process documentation, and establishing performance metrics (KPIs).
• Excellent interpersonal, verbal, and written communication skills for effective collaboration and reporting with demonstrated ability to lead and influence teams to drive proactive problem-solving and effective decision-making in a matrix environment
• Knowledge of data-driven methodologies such as Lean Six Sigma or Kaizen to support process improvement efforts; proficient at process mapping and data analysis
• Proven ability to manage complex projects and lead cross-functional teams.
• Strong ability to analyze data, identify operational issues, and develop solutions to enhance operational efficiency
• Individuals must demonstrate the ability to interact successfully in a dynamic and culturally diverse workplace.
• Must successfully exhibit Insmed’s five (5) core corporate competencies of: Collaboration, Accountability, Passion, Respect, and Integrity; along with any other position specific competencies.

Responsibilities

• Train and guide CST members to proactively identify, assess, and mitigate risks to patient safety and data integrity throughout the clinical trial's lifecycle providing input based on trend assessment and therapeutic area expectations.
• Collaborate with CST to design and implement study-specific risk-based monitoring and data analytics strategies.
• Oversee the development, maintenance, and execution of study-specific Risk Register and Plans.
• Provide advice and possible recommendations for enhancements to the framework and timely completion of goals/tasks.
• Evaluate current clinical operational processes and workflows to identify inefficiencies, conduct root cause analysis (RCA) to determine solutions, propose and implement improvements to enhance efficiency and quality.
• Mentor teams in process improvement philosophies to cultivate a company-wide culture of continuous improvement.
• Support implementation efforts (e.g., training, creation of performance support tools) for new/revised procedures
• Attend relevant external courses and/or conferences to stay current with best practices and evolving industry trends, share and apply relevant learnings with Insmed team.
• Collaborate with cross-functional teams (Clinical Trial Operations, Clinical Development, Data Management, Programming, Regulatory, Quality Assurance, DSPV) to drive operational excellence.
• Provide oversight of vendors/contractors supporting risk management activities

Benefits

• Comprehensive medical, dental, and vision coverage and mental health support, annual wellbeing reimbursement, and access to our Employee Assistance Program (EAP)
• Generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration
• 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), and company-paid life and disability insurance
• Company Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities
• Employee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level