Senior Clinical Contracts & Outsourcing Lead

Isomorphic Labs; Cambridge (MA); Hybrid; USD 110,000 - 160,000; Full time

Job summary

Isomorphic Labs in Cambridge, MA, is seeking a Clinical Contracts Manager to act as the primary contact for vendor outsourcing and contracting within oncology and rare disease programs. You will drive vendor selection, negotiate MSAs/CTAs, and manage study budgets while ensuring GCP/FDA compliance and cross‑functional collaboration with Clinical Operations, Legal, and Finance.

You will lead RFI/RFP processes, assess AI tools for contract lifecycle improvements, and oversee the lifecycle of trial

Qualifications

• Bachelor’s degree (BA/BS); degree in Healthcare, Science or Finance preferred.
• Minimum 5+ years of experience in clinical outsourcing, contracting, procurement, or finance within a pharmaceutical, biopharma, CRO, or clinical research setting.
• In-depth knowledge of clinical trial execution, CRO outsourcing models, and regulatory guidelines (GCP/FDA).
• Oncology and/or Rare Disease experience required.
• Strong contract negotiation, budget management, and project management skills with a proven track record across multi‑project timelines.
• Exceptional written and oral communication skills, with the ability to convey engagement objectives and maintain effective dialogue with internal and external partners.
• Demonstrates an AI‑curious mindset, with an interest in exploring and leveraging emerging AI technologies to streamline contract lifecycle management and enhance operational efficiency.
• Strategic and analytical thinker with excellent problem‑solving capabilities and adaptability in fast‑paced, matrixed environments.
• Proven ability to build strong cross‑functional relationships, mentor team members, and drive efficient business solutions across functional and regional boundaries.

Responsibilities

• Provide primary outsourcing and vendor management support for clinical development functional areas across the portfolio.
• Independently lead RFI and RFP processes, analyze supplier services, proposals, and budgets, conduct bid defense meetings, and recommend vendor selection for executive decision-making.
• Negotiate and execute complex vendor agreements and Master Service Agreements (MSAs) with preferential terms and pricing.
• Define and implement vendor assessment criteria, benchmark metrics, and process improvement initiatives to optimize clinical outsourcing.
• Drive negotiations for Clinical Trial Agreements (CTAs) and investigator budgets directly with clinical sites.
• Partner closely with Clinical Trial Managers, program teams, and CROs to ensure vendors deliver against study timelines, quality standards, and budget expectations.
• Assess and integrate potential AI tools to facilitate and enable contract negotiations and management.
• Ensure full consistency between contractual agreements and operational trial implementation.
• Monitor study progress, vendor deliverables, and resource allocation throughout the study lifecycle, supporting teams in final financial reconciliation at study closeout.
• Actively monitor study progress for scope changes, driving negotiations for change orders and associated costs to minimize sponsor risk.
• Identify contractual risks, mitigate scope creep, and ensure strict adherence to FMV standards, legal requirements, and healthcare compliance.
• Proactively address contractual challenges, develop risk mitigation plans, and facilitate escalation management for leadership review when needed.
• Participate in vendor oversight and governance meetings, supporting study teams in resolving vendor performance issues.
• Seek out, assess and potentially assist in onboarding potential AI solutions within this space that would prove helpful to the organization.

Skills

Contract negotiation

Budget management

Clinical outsourcing

GCP FDA knowledge

Project management

Education

Bachelor's degree in Healthcare/Science/Finance

Job description

Isomorphic Labs in Cambridge, MA, is seeking a Clinical Contracts Manager to act as the primary contact for vendor outsourcing and contracting within oncology and rare disease programs. You will drive vendor selection, negotiate MSAs/CTAs, and manage study budgets while ensuring GCP/FDA compliance and cross‑functional collaboration with Clinical Operations, Legal, and Finance.

You will lead RFI/RFP processes, assess AI tools for contract lifecycle improvements, and oversee the lifecycle of trial