Senior Clinical Outsourcing Manager (Remote Eligible)
Denali Therapeutics
11 hours ago
Remote friendly (South San Francisco, CA)
United States
Clinical Research and Development
Key Accountabilities / Core Job Responsibilities:
- Direct and coordinate all clinical outsourcing needs, including vendor identification and selection; RFP and bid defenses; negotiating SOW and budgets including change orders; co-manage outsourcing budgets; performance metrics; and vendor oversight/governance.
- Lead vendor identification, evaluation, and selection for clinical development programs (CROs and specialty service providers).
- Develop and manage RFIs, RFPs, bid analyses, and vendor recommendation materials.
- Lead contract, scope of work, and budget negotiations with clinical vendors.
- Manage vendor governance: performance reviews, issue escalation, scorecard metrics, and continuous improvement.
- Partner with Clinical Operations, Finance, Legal, and Procurement to align outsourcing strategies.
- Evaluate vendor capabilities, operational risks, and pricing.
- Facilitate bid defense meetings, governance reviews, and supplier business reviews.
- Oversee contract administration: change orders, purchase order management, reconciliation, and vendor payment tracking.
- Support audit readiness and participate in internal/external audits related to vendor oversight and contracting.
- Oversee CRO negotiation of site level budgets and CTAs.
- Contribute to outsourcing processes, standards, templates, and operational best practices.
Qualifications/Skills:
- Bachelor’s degree in life sciences, business, or related field; advanced degree preferred.
- 7+ years in biotech/pharmaceutical industry with significant clinical outsourcing, vendor management, and contract negotiation experience.
- Demonstrated outsourcing strategy and vendor relationship management across clinical development phases.
- Strong understanding of clinical trial operations and drug development.
- Experience negotiating complex contracts, SOWs, budgets, and change orders with CROs/clinical providers.
- Strong analytical, financial, communication, and stakeholder management skills.
- Clinical financial management experience (budgeting, accruals, forecasting, vendor performance metrics) preferred.
Compensation/Benefits:
- Salary range: $155,000–$202,000; competitive total rewards including 401k, healthcare coverage, and ESPP.
- Learn more: https://www.denalitherapeutics.com/careers
- Direct and coordinate all clinical outsourcing needs, including vendor identification and selection; RFP and bid defenses; negotiating SOW and budgets including change orders; co-manage outsourcing budgets; performance metrics; and vendor oversight/governance.
- Lead vendor identification, evaluation, and selection for clinical development programs (CROs and specialty service providers).
- Develop and manage RFIs, RFPs, bid analyses, and vendor recommendation materials.
- Lead contract, scope of work, and budget negotiations with clinical vendors.
- Manage vendor governance: performance reviews, issue escalation, scorecard metrics, and continuous improvement.
- Partner with Clinical Operations, Finance, Legal, and Procurement to align outsourcing strategies.
- Evaluate vendor capabilities, operational risks, and pricing.
- Facilitate bid defense meetings, governance reviews, and supplier business reviews.
- Oversee contract administration: change orders, purchase order management, reconciliation, and vendor payment tracking.
- Support audit readiness and participate in internal/external audits related to vendor oversight and contracting.
- Oversee CRO negotiation of site level budgets and CTAs.
- Contribute to outsourcing processes, standards, templates, and operational best practices.
Qualifications/Skills:
- Bachelor’s degree in life sciences, business, or related field; advanced degree preferred.
- 7+ years in biotech/pharmaceutical industry with significant clinical outsourcing, vendor management, and contract negotiation experience.
- Demonstrated outsourcing strategy and vendor relationship management across clinical development phases.
- Strong understanding of clinical trial operations and drug development.
- Experience negotiating complex contracts, SOWs, budgets, and change orders with CROs/clinical providers.
- Strong analytical, financial, communication, and stakeholder management skills.
- Clinical financial management experience (budgeting, accruals, forecasting, vendor performance metrics) preferred.
Compensation/Benefits:
- Salary range: $155,000–$202,000; competitive total rewards including 401k, healthcare coverage, and ESPP.
- Learn more: https://www.denalitherapeutics.com/careers