CSL · 12 hours ago
Director, Process, Standards and Signal Interpretation Lead
King of Prussia, PA
Full-time
Hybrid
Director/Executive
10+ years expCSL Behring is a global biotherapeutics leader driven by our promise to save lives. The PSSI Lead supports innovative continuous improvement opportunities in site monitoring and oversight processes, ensuring compliance and collaboration with various stakeholders to enhance clinical trial data quality.
BiotechnologyHealth CareHealth DiagnosticsMedical
Responsibilities
Developing and reviewing SMMO owned operational metrics, study plan variances, and trend reports to identify issues and recommend mitigations
Developing innovative flexible and sustainable practices to drive excellence in SMMO delivery
Reviews start-up, monitoring, engagement and site management oversight metrics across the organization/enterprise/portfolio for trends and provides summaries and recommendations to SMMO LT to drive business practice and adoption
Works closely with stakeholders proactively to ensure a consistent understanding of signals and metrics surfacing and influence the organization and CRO partners to drive process improvements and standardization
Collaborates with leaders at our wCRO Partners, Clinical Compliance and CQA on monitoring and oversight processes
Responsible for working cross functionally to drive consistency and efficiencies, and identify opportunities for site related process improvement in response to, but not limited to, compliance changes, external influences such as regulatory inspections, business strategy, performance signals, feedback from stakeholders, industry benchmarks
Serves as the initial point of contact and technical expert for questions about, monitoring and oversight related processes, systems and responsibilities
Serves as the SMMO process point person for trending site related deviations and trend analysis, evaluating and supporting, inspection readiness, inspections and audit findings; supporting observation mgt and CAPA resolution where appropriate
Leads discussions with tech enablement groups both within CSL and at CRO partners to optimize AI innovations around study start-up, monitoring and monitoring oversight
Qualification
Required
A seasoned clinical trials expert with extensive experience in global clinical trials and site management, with a strong understanding of Good Clinical Practices (GCPs) and regulatory operations
Minimum of 10 years experience in site monitoring or central monitoring process development
Analytical Skills: Strong analytical thinking and problem-solving skills are essential for interpreting complex data trends and identifying risks
Tech and systems savvy; experience of modelling and AI
Maintains scientific/operational knowledge and expertise to possess credibility to discuss with higher level management and peers
Strong interpersonal skills - establishes strong relationships with customers
Leadership: The ability to lead discussions, build consensus, and influence cross-functional teams is important for success in this role
Creativity and/or ability to put innovative approaches into practice in clinical development
Strategic thinking and targeted problem solving skills
Demonstrated ability to navigate and negotiate competing priorities in a challenging environment
Experience in managing processes with a continuous improvement approach
Ability to think strategically and to quickly analyze complex circumstances and problems, and to drive appropriate decisions and actions
Company
CSL
CSL develops innovative biotherapies and influenza vaccines that save lives, and help people with life-threatening medical conditions.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$111M2013-12-20Acquired
2004-02-06Post Ipo Equity· $111M
1994-06-03IPO
Leadership Team
Jeffrey Ball
Chief Sustainability Officer
Joy Linton
Strategic Advisor
Recent News
Pharma Letter
2026-01-03
2025-10-29
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