Senior Director, Vendor Strategy and Delivery (Secondment - 7 Months)
About the position
This 7-month secondment is an opportunity for a Senior Director to provide end-to-end oversight of SDSA’s vendors so that clinical deliverables are high-quality, on time, and inspection-ready. By strengthening delivery governance and compliance rigor across external partners, you will help ensure teams have the reliable analyses and documentation needed to support sound decisions and regulatory submissions—ultimately helping medicines reach patients without avoidable delays. WHAT YOU WILL ACHIEVE Improved predictability and transparency of vendor delivery through clear performance measures (KPIs/SLAs), trend reporting, and actionable remediation plans. Stronger on-time delivery for critical milestones through proactive risk identification, timely escalation, and documented issue resolution. Reduced rework and more consistent quality of programming deliverables through alignment to standards, clearer expectations, and effective QC practices. Greater inspection readiness via consistent application of compliance expectations, SOP alignment, and audit-ready documentation. Faster cross-functional decision-making through clear governance, stakeholder alignment, and executive-ready communications. On-time delivery improves for critical milestones; risks/issues are escalated early with documented resolutions. Deliverables meet agreed technical standards with reduced rework and predictable QC outcomes. Compliance expectations are consistently applied; audit/inspection readiness is strengthened. Stakeholders report improved communication, alignment, and decision velocity.
Responsibilities
• Technical evaluation: Assess vendors’ statistical programming capabilities, toolsets, resourcing models, and delivery approaches to confirm alignment with program needs and internal standards.
• Lead SDSA’s vendor refresh activities, including evaluation of all existing vendors and selection of preferred vendors by end of 2026.
• Regulatory compliance: Ensure vendor processes and deliverables align with applicable regulatory expectations, internal SOPs, and audit-ready documentation practices.
• Project coordination: Coordinate communication between internal teams and vendors; evaluate study teams’ vendor oversight adherence; help monitor KPIs/SLAs to ensure successful delivery.
• Governance & performance management: Coordinate and lead vendor quarterly governance meetings, escalate risks, and drive corrective/preventive actions as needed.
• Stakeholder leadership: Align cross-functional stakeholders on scope, priorities, and decision-making; synthesize complex updates into clear executive-level communications.
• Continuous improvement: Identify recurring delivery bottlenecks and recommend process, tooling, or contract/SOW improvements to increase predictability and quality.
Requirements
• BA/BS with 12+ years and / or MBA/MS with 10+ years of experience and / or PhD or JD with 7+ years of experience.
• Senior leadership experience (Senior Director level or equivalent) in Biometrics, Statistical Programming, Data Management, Clinical Development/Operations, or a closely related function.
• Demonstrated experience managing external vendors/partners, including performance oversight, KPI/SLA management, and structured governance.
• Understanding of statistical programming deliverables and lifecycle (e.g., analysis datasets, TFLs, specifications, QC, submission support).
• Working knowledge of regulated environment expectations (e.g., GxP-aligned practices, inspection readiness, documentation rigor).
• Proven ability to lead cross-functional teams, influence without authority, and drive decisions in ambiguous or fast-moving environments.
• Excellent written and verbal communication skills, including executive-ready status reporting.
Nice-to-haves
• MD/DVM with 5+ years of experience.
• Experience leading vendor selection or technical due diligence (e.g., RFP development, vendor assessment frameworks, recommendation memos).
• Experience supporting regulatory submissions and/or responding to health authority questions.
• Change management experience, including driving process adoption across multiple teams and geographies.
This 7-month secondment is an opportunity for a Senior Director to provide end-to-end oversight of SDSA’s vendors so that clinical deliverables are high-quality, on time, and inspection-ready. By strengthening delivery governance and compliance rigor across external partners, you will help ensure teams have the reliable analyses and documentation needed to support sound decisions and regulatory submissions—ultimately helping medicines reach patients without avoidable delays. WHAT YOU WILL ACHIEVE Improved predictability and transparency of vendor delivery through clear performance measures (KPIs/SLAs), trend reporting, and actionable remediation plans. Stronger on-time delivery for critical milestones through proactive risk identification, timely escalation, and documented issue resolution. Reduced rework and more consistent quality of programming deliverables through alignment to standards, clearer expectations, and effective QC practices. Greater inspection readiness via consistent application of compliance expectations, SOP alignment, and audit-ready documentation. Faster cross-functional decision-making through clear governance, stakeholder alignment, and executive-ready communications. On-time delivery improves for critical milestones; risks/issues are escalated early with documented resolutions. Deliverables meet agreed technical standards with reduced rework and predictable QC outcomes. Compliance expectations are consistently applied; audit/inspection readiness is strengthened. Stakeholders report improved communication, alignment, and decision velocity.
Responsibilities
• Technical evaluation: Assess vendors’ statistical programming capabilities, toolsets, resourcing models, and delivery approaches to confirm alignment with program needs and internal standards.
• Lead SDSA’s vendor refresh activities, including evaluation of all existing vendors and selection of preferred vendors by end of 2026.
• Regulatory compliance: Ensure vendor processes and deliverables align with applicable regulatory expectations, internal SOPs, and audit-ready documentation practices.
• Project coordination: Coordinate communication between internal teams and vendors; evaluate study teams’ vendor oversight adherence; help monitor KPIs/SLAs to ensure successful delivery.
• Governance & performance management: Coordinate and lead vendor quarterly governance meetings, escalate risks, and drive corrective/preventive actions as needed.
• Stakeholder leadership: Align cross-functional stakeholders on scope, priorities, and decision-making; synthesize complex updates into clear executive-level communications.
• Continuous improvement: Identify recurring delivery bottlenecks and recommend process, tooling, or contract/SOW improvements to increase predictability and quality.
Requirements
• BA/BS with 12+ years and / or MBA/MS with 10+ years of experience and / or PhD or JD with 7+ years of experience.
• Senior leadership experience (Senior Director level or equivalent) in Biometrics, Statistical Programming, Data Management, Clinical Development/Operations, or a closely related function.
• Demonstrated experience managing external vendors/partners, including performance oversight, KPI/SLA management, and structured governance.
• Understanding of statistical programming deliverables and lifecycle (e.g., analysis datasets, TFLs, specifications, QC, submission support).
• Working knowledge of regulated environment expectations (e.g., GxP-aligned practices, inspection readiness, documentation rigor).
• Proven ability to lead cross-functional teams, influence without authority, and drive decisions in ambiguous or fast-moving environments.
• Excellent written and verbal communication skills, including executive-ready status reporting.
Nice-to-haves
• MD/DVM with 5+ years of experience.
• Experience leading vendor selection or technical due diligence (e.g., RFP development, vendor assessment frameworks, recommendation memos).
• Experience supporting regulatory submissions and/or responding to health authority questions.
• Change management experience, including driving process adoption across multiple teams and geographies.