Director, Continuous Improvement
Pharmaron
- Baltimore, MD
- $120,000-155,000 per year
- Permanent
- Full-time
enhance protocol execution, reduce variability, and ensure the highest standards of compliance and patient safety. Leveraging methodologies such
as Lean, Six Sigma, Kaizen and etc, this role will lead initiatives that improve study start-up, data integrity, cycle times, and overall performance.
This position will gradually grow and lead a team of improvement professionals while aligning CI efforts with both regulatory requirements and
business strategy.Additional tasks:
- Establish the Continuous Improvement function within the Phase I Unit, including structure, governance, and strategic roadmap.
- Design and implement operational excellence initiatives that improve efficiency, quality, patient safety, and compliance within early phase clinical trials.
- Hire and develop a CI team over time, scaling capabilities to support growing organizational needs.
- Lead cross-functional improvement efforts across clinical operations, quality assurance, regulatory affairs, laboratory services, data
- Facilitate root cause analyses and process mapping workshops to address complex operational and clinical challenges.
- Collaborate with Principal Investigators, Research Coordinators, QA teams, and executive leadership to prioritize improvement opportunities
- Develop and monitor KPIs that reflect study performance, patient throughput, regulatory readiness, and process efficiency.
- Integrate CI practices with internal audits, CAPA processes, and quality systems.
- Bachelor's degree or Master's or MBA.in Life Sciences, Healthcare Administration, Engineering, or related field with 10+ years of experience in clinical research, clinical operations, or quality systems.
- 3-5+ years in a senior or director-level improvement leadership role.
- Proven track record of leading continuous improvement initiatives in a regulated environment (clinical research, pharma, CRO, or
- Certification in Lean, Six Sigma, Kaizen, or equivalent process improvement methodologies (Black Belt or higher preferred).
- Experience building or scaling a CI or operational excellence function within a clinical or life sciences setting.
- Strong analytical, facilitation, and change management skills with the ability to influence at all levels of the organization.
- Familiarity with FDA regulations, ICH-GCP guidelines, CAPA systems, and audit readiness best practices.
- Experience in a small or large CRO environment strongly preferred.
- Insurance including Medical, Dental & Vision with significant employer contributions
- Employer-funded Health Reimbursement Account
- Healthcare & Dependent Care Flexible Spending Accounts
- 100% Employer-paid Employee Life and AD&D Insurance, Short and Long Term Disability Insurance
- 401k plan with generous employer match
- Access to an Employee Assistance Program