Associate Director, Clinical OutsourcingPrinceton, New Jersey, United States, South San Francisco, California, United States
Associate Director, Clinical Outsourcing
About Us
Position Title: Associate Director, Clinical Outsourcing
Department: Development Business Operations
Reports To: Director, Development Business Operations
Location: South San Francisco, CA (preferred) or Princeton, NJ – On-site 4 days per week (Mon to Thurs)
Role: Associate Director, Clinical Outsourcing
The Associate Director will play a key role in managing clinical vendor contracts/budgets to support Kardigan’s portfolio of late-stage cardiovascular assets. This role reports to the Director of Development Business Operations and will work cross-functionally with Clinical Operations, Finance, Legal, Clinical QA, and other functional groups as required. The ideal candidate will have proven experience managing CROs and vendors, be an analytical and proactive individual with a proven ability to collaborate effectively internally and externally, and thrive in a dynamic, fast-paced environment.
Key Responsibilities:
- Oversees and coordinates clinical vendor evaluation and selection, including generating and distributing RFIs/RFPs and organizing competitive bid defense meetings to formally assess vendor capabilities
- Partner with internal stakeholders and external vendors to support contract negotiations, including CDAs, MSAs, SOWs, and Change Orders
- Performs budget analyses in conjunction with clinical study execution teams and functional leads for cost optimization
- Partner with study execution teams and finance to manage accruals for clinical trials and support forecasting
- Assists Clinical QA with onboarding/due diligence of new vendors
- Submits purchase order requisitions through procurement management system
Ideal Candidate
- 8+ years of relevant experience in Development Business Operations, Clinical Business Operations, Clinical Outsourcing, or R&D Strategic Sourcing
- Strong understanding of clinical trial processes, vendor management, and regulatory requirements (e.g., ICH-GCP, 21 CFR Part 11)
- Proven experience selecting and managing CROs and vendors
- Strong analytical and problem-solving skills
- Excellent communication, negotiation, and interpersonal skills
- Bachelor’s degree required, advanced degree desirable
- Ability to thrive in a fast-paced, dynamic environment
Exact Compensation may vary based on skills, experience and location.
Pay range
$180,000 - $246,000 USD
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