Senior Manager, Grants and Contracts

Overview

The Sr. Manager, Grants and Contracts is responsible for leading complex clinical contracting and budgeting activities that support Celldex's global clinical development programs. This role serves as a strategic partner to Clinical Operations, Legal, Finance, Procurement, and external partners, ensuring the timely negotiation, execution, and management of clinical site agreements, budgets, and vendor contracts.

The successful candidate will operate with a high degree of independence and accountability, driving negotiations and business decisions forward while balancing operational objectives, financial considerations, compliance requirements, and risk. This individual is expected to identify solutions, make informed recommendations, and proactively resolve challenges rather than relying on escalation for routine ambiguity or obstacles.

A primary focus of this role will be clinical site budget negotiations and vendor contracting. The Sr. Manager will serve as a trusted advisor to internal stakeholders, confidently navigating complex situations, exercising sound judgment, and acting as a key resource and backup to the Associate Director when needed to ensure continuity of operations and decision-making.

Clinical Site Contracts & Budget Management

• Owns the end-to-end negotiation of global Clinical Trial Agreements (CTAs) site budgets and ancillary documents, whether managing directly or via a CRO, ensuring alignment with study goals and timelines. Serves as a primary driver and decision-maker, escalating strategically when needed while maintaining accountability for outcomes.
• Negotiate Investigator Initiated Research (IIR) Agreements and Sponsored Research Agreements (SRA) in support of clinical development.
• Serve as the primary driver of assigned negotiations, proactively identifying obstacles, proposing solutions, and advancing agreements to execution.
• Independently evaluate contractual, financial, and operational risks and develop recommendation-based solutions that balance business objectives with appropriate risk management.
• Maintaining strong working relationships with internal and external partners while protecting Celldex interests.
• Exercise sound business judgment when navigating complex or ambiguous situations, determining when issues can be resolved independently and when leadership engagement is warranted.
• Oversee CRO development of and lead internal review and approval of country-specific CTA, budget, and ancillary agreement templates supporting global clinical studies.
• Partner with Clinical Operations teams to develop study-specific contracting and budgeting strategies that support enrollment and execution goals.

Vendor Contracting & Management

• Independently lead negotiation and execution of vendor agreements including Master Services Agreements (MSAs), Statements of Work (SOWs), Change Orders (COs), Confidential Disclosure Agreements (CDAs), Consulting Agreements, and related contracts.
• Serve as a strategic partner to study teams during vendor selection and contracting activities, ensuring contractual considerations are appropriately addressed.
• Drive contract negotiations to resolution by facilitating stakeholder alignment, proposing alternatives, and balancing business needs with contractual risk.
• Collaborate with Legal, Clinical Operations, and Finance to ensure vendor agreements support study objectives and organizational priorities.
• Monitor contract amendments, scope changes, and financial impacts throughout the vendor lifecycle.

Data Privacy & Compliance

• Negotiate and execute Data Processing Agreements (DPAs) with sites and vendors consistent with GDPR and global privacy requirements.
• Ensure contract and budget activities are conducted in compliance with applicable regulations, internal policies, GCP, HIPAA, FCPA, and company standards.
• Maintain awareness of evolving regulatory and industry requirements impacting clinical contracting and budgeting activities.

Financial Oversight & Forecasting

• Gather, populate, and oversee monthly accrual reporting for assigned studies in partnership with Clinical Operations and Finance.
• Provide rationale and recommendations for study-specific accrual approaches
• Identify and elevate inconsistencies in data.

Cross-Functional Leadership & Business Partnership

• Serve as a senior representative of the Grants and Contracts function in cross-functional meetings and project teams.
• Act as a trusted partner to Clinical Operations, Legal, Finance, and study teams by providing guidance, recommendations, and practical solutions.
• Anticipate challenges, identify gaps, and proactively drive resolution of issues impacting study execution or contractual timelines.
• Track and advance assigned action items through completion, ensuring accountability and visibility across stakeholders.
• Support departmental process improvements and provide recommendations to enhance efficiency, quality, scalability, and business outcomes.
• Act as a delegate and backup to the Associate Director when…