Associate Director – Clinical Outsourcing

Job not on LinkedIn

🔥 9 minutes ago

🇺🇸 United States – Remote

💵 $175k - $250k / year

⏰ Full Time

🟠 Senior

👨‍⚕️ Medical Director

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BBOT

WebsiteLinkedInAll Job Openings

51 - 200 employees

🏥 Healthcare

💼 Consulting

🧬 Biotechnology

Healthcare • Consulting • Biotechnology

BBOT is a biotechnology company developing targeted therapies for cancers driven by RAS signaling and PI3Kα. The company focuses on rational drug design to inhibit the active ON state of RAS and to selectively block RAS-driven PI3K activation, aiming at multiple KRAS mutants and novel approaches to maximize target inhibition. BBOT translates decades of RAS biology research into therapeutic candidates intended to improve outcomes for patients with RAS- and PI3Kα-driven tumors.

📋 Description

• Own and continuously refine BBOT’s clinical outsourcing strategy • Lead CRO and vendor selection for clinical programs, including RFPs, RFIs, vendor evaluations, and bid defense meetings • Establish and maintain preferred provider relationships with pre-negotiated pricing frameworks • Identify outsourcing needs early and ensure vendors are selected and onboarded ahead of program timelines • Negotiate CRO and vendor contracts, work orders, change orders, master service agreements, and clinical budgets • Manage the full contract lifecycle from scope development and proposal review through amendments, change orders, close-out, and financial reconciliation • Evaluate vendor proposals and budgets against industry benchmarks and identify risks and pricing gaps • Partner with Legal on compliant vendor agreements and coordinate PVAs, confidentiality agreements, and quality agreements • Track contract timelines, expiry dates, and renewals • Own monthly and quarterly financial reviews, accruals, purchase order management, and budget tracking • Review and approve vendor invoices against contracts, work orders, and deliverables • Maintain budget forecasts and report spend status, variances, and risks to program teams, Finance, and senior leadership • Support clinical trial budget development with cost estimates, benchmarking data, and vendor inputs • Lead or support final financial reconciliation for vendor engagements • Establish vendor governance frameworks with KPIs, scorecards, escalation pathways, and performance reviews • Serve as primary operational contact for CRO and vendor relationships • Identify and resolve performance, quality, and timeline risks • Ensure outsourced activities comply with GCP, regulations, and BBOT SOPs; support audit and inspection readiness • Partner with Clinical Operations teams to integrate outsourced partners and drive accountability for deliverables and milestones

🎯 Requirements

• Bachelor’s degree in life sciences, business, or a related field; advanced degree preferred • Minimum 10 years of experience in clinical outsourcing, vendor management, or clinical operations in a pharmaceutical or biotechnology setting • Direct experience in CRO contracting, budget negotiation, and financial management • Experience managing the full vendor contract lifecycle, including RFP development, proposal evaluation, contract negotiation, change order management, and close-out • Strong financial acumen with hands-on experience supporting clinical trial budget tracking, accruals, and monthly/quarterly finance reviews • Working knowledge of ICH-GCP and regulatory requirements governing clinical trial outsourcing • Excellent negotiation, organizational, and communication skills • Ability to manage multiple vendor relationships and competing priorities simultaneously • Proven experience independently managing complex, multi-vendor outsourcing programs across global oncology trials (Director level) • Expertise in CRO and vendor contract negotiation, budget development, and financial oversight at program and portfolio level (Director level) • Experience establishing preferred provider frameworks and strategic outsourcing models (Director level) • Deep working knowledge of ICH-GCP, FDA regulations, and global regulatory requirements (Director level) • Oncology experience preferred; early-phase oncology experience a plus • Prior experience in a lean, startup, or high-growth biotech environment highly desirable