Associate Director – Clinical Outsourcing

This is a fully remote position, open to applicants in United States.

📋 Description

• Take ownership of and continually enhance BBOT’s strategy for clinical outsourcing.

• Oversee the selection of CROs and vendors for clinical programs, which includes managing RFPs, RFIs, vendor assessments, and bid defense meetings.

• Establish and sustain relationships with preferred providers that include pre-negotiated pricing structures.

• Proactively identify outsourcing requirements and ensure timely selection and onboarding of vendors in alignment with program schedules.

• Negotiate contracts with CROs and vendors, including work orders, change orders, master service agreements, and clinical budgets.

• Manage the entire contract lifecycle from scope development and proposal evaluation through amendments, change orders, closure, and financial reconciliation.

• Assess vendor proposals and budgets against industry standards while identifying risks and pricing discrepancies.

• Collaborate with Legal to ensure vendor agreements are compliant and manage PVAs, confidentiality agreements, and quality agreements.

• Monitor contract timelines, expiration dates, and renewal processes.

• Oversee monthly and quarterly financial reviews, accruals, purchase order management, and budget oversight.

• Review and authorize vendor invoices in accordance with contracts, work orders, and deliverables.

• Maintain budget forecasts and report spending status, variances, and risks to program teams, Finance, and senior leadership.

• Assist in the development of clinical trial budgets by providing cost estimates, benchmarking data, and vendor insights.

• Lead or assist in the final financial reconciliation for vendor engagements.

• Develop vendor governance frameworks that include KPIs, scorecards, escalation pathways, and performance evaluations.

• Act as the primary operational contact for CRO and vendor relationships.

• Identify and address performance, quality, and timeline-related risks.

• Ensure that outsourced activities adhere to GCP, regulations, and BBOT SOPs, and support audit and inspection readiness.

• Collaborate with Clinical Operations teams to integrate outsourced partners and ensure accountability for deliverables and milestones.

⛳️ Requirements

• Bachelor’s degree in life sciences, business, or a related discipline; an advanced degree is preferred.

• At least 10 years of experience in clinical outsourcing, vendor management, or clinical operations within a pharmaceutical or biotechnology context.

• Direct experience in CRO contracting, budget negotiation, and financial management.

• Proficient in managing the full vendor contract lifecycle, which includes RFP development, proposal evaluation, contract negotiation, change order management, and closure.

• Strong financial acumen with practical experience in clinical trial budget tracking, accruals, and monthly/quarterly financial reviews.

• Familiarity with ICH-GCP and regulatory standards governing clinical trial outsourcing.

• Exceptional negotiation, organizational, and communication abilities.

• Capability to manage multiple vendor relationships and competing priorities concurrently.

• Proven track record of independently overseeing complex, multi-vendor outsourcing initiatives in global oncology trials (Director level).

• Expertise in CRO and vendor contract negotiation, budget formulation, and financial management at both program and portfolio levels (Director level).

• Experience in creating preferred provider frameworks and strategic outsourcing models (Director level).

• Extensive knowledge of ICH-GCP, FDA regulations, and global regulatory requirements (Director level).

• Experience in oncology preferred; early-phase oncology experience is a plus.

• Prior experience in a lean, startup, or high-growth biotech environment is highly desirable.

🏝️ Benefits

• Comprehensive health and wellness programs.

• Competitive salary and performance-based bonuses.

• Opportunities for professional development and career growth.

• Flexible working arrangements to promote work-life balance.