Sr. Director, Clinical Outsourcing and Vendor Management
Vendor Strategy & Governance
Develop and implement City Therapeutics' clinical vendor management strategy and governance framework.
Serve as the primary operational lead for vendor selection, qualification, onboarding, oversight, and performance management.
Establish vendor governance committees, business reviews, and performance scorecards.
Lead cross-functional vendor oversight meetings and ensure alignment between internal stakeholders and external partners.
Drive continuous improvement initiatives across vendor relationships and service delivery models.
Vendor Selection & Contracting Support
Partner with Clinical Operations, Clinical Development, Legal, Quality, and Finance to support vendor selection activities.
Lead RFI, RFP, bid defense, and vendor evaluation processes.
Develop vendor assessment criteria and recommendations for executive decision-making.
Drive and collaborate with internal stakeholders on contract negotiations, change orders, and financial oversight activities.
Performance & Risk Management
Define and monitor vendor KPIs, SLAs, and quality metrics.
Proactively identify risks, performance gaps, and operational challenges.
Develop mitigation plans and drive issue resolution with internal and external stakeholders.
Ensure vendors meet quality, compliance, and operational expectations.
Clinical Trial Execution Support
Prioritize closely with Clinical Trial Managers and program teams to ensure vendors deliver against study timelines, quality standards, and budget expectations.
Monitor vendor deliverables and resource allocation across programs.
Facilitate escalation management and executive-level communications when needed.
Process Development & Continuous Improvement
Build scalable vendor management processes suitable for a growing clinical-stage biotech company.
Develop SOPs, work instructions, templates, scorecards, and governance tools.
Implement best practices that improve efficiency, transparency, and accountability.
Support inspection readiness and quality initiatives related to vendor oversight.
Qualifications
- Bachelor's degree in Life Sciences, Nursing, Health Sciences, Business, or related field.
- 15+ years of clinical research experience within biotechnology, pharmaceutical, or CRO environments.
- 8+ years of direct vendor management, alliance management, or clinical outsourcing experience.
- Demonstrated experience managing global CROs and multiple clinical service providers.
- Strong understanding of ICH-GCP, FDA, EMA, and global clinical trial regulations.
- Experience leading RFPs, vendor selection processes, contract negotiations, and governance activities.
- Excellent communication, negotiation, and stakeholder management skills.
- Ability to influence across functions and organizational levels.
Preferred
- Advanced degree (MS, MPH, MBA, PharmD, or PhD).
- Experience supporting early-phase and first-in-human clinical studies.
- Experience within emerging biotechnology companies.
- Experience building vendor oversight frameworks from the ground up.
- Knowledge of RNAi, rare disease, oncology, immunology, or other complex therapeutic areas.