Senior Manager, Grants and Contracts
Overview
Celldex is pioneering new horizons in immunology to deliver life-changing therapies. We are relentless in our pursuit of novel antibody-based treatments that engage the human immune system and directly affect critical pathways to improve the lives of patients with allergic, inflammatory, and autoimmune disorders. We have built a culture where innovative and talented people thrive—focusing a significant effort on attracting and retaining passionate and motivated employees who want to play a role in helping people with serious health conditions and who see this effort as personally rewarding. In our highly entrepreneurial environment, employees are empowered and the opportunity for professional development occurs every day.
Responsibilities
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.
Independently evaluate contractual, financial, and operational risks and develop recommendation-based solutions that balance business objectives with appropriate risk management.
Maintain 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.
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.
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.
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.
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 escalate inconsistencies in data.
Act 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 needed, helping maintain continuity of operations, stakeholder support, and decision-making.
Maintain contract repositories and supporting documentation to ensure compliance, audit readiness, and organizational visibility.
Support tracking and enhancements to departmental KPIs.
Contribute to development of scalable processes, templates, and best practices supporting organizational growth.
Participate in initiatives designed to improve contracting efficiency, budget management, vendor oversight, and cross-functional collaboration.
Qualifications
Bachelor's degree or equivalent combination of education and relevant experience required.
5+ years of direct experience negotiating clinical trial agreements, site budgets, and/or vendor contracts within a pharmaceutical, biotechnology, CRO, or clinical research environment.
6+ years of experience supporting Clinical Development, Clinical Operations, Grants and Contracts, or related functions.
Demonstrated experience independently leading complex contract and budget negotiations and managing stakeholder relationships across multiple functions and geographies.
Strong preference for experience negotiating global contracts and budgets.
Experience supporting CRO-managed studies preferred.
Knowledge of GDPR requirements and experience negotiating data privacy terms for sites and vendors preferred.
Strong understanding of healthcare compliance requirements including GCP, HIPAA, FCPA, and applicable clinical research regulations.
Advanced contract negotiation skills within a clinical research environment.
Demonstrated ability to independently navigate complex contracting, budgeting, and vendor management challenges while balancing business needs and risk considerations.
Strong business judgment with the confidence to make informed decisions, manage ambiguity, and appropriately balance compliance, operational priorities, and financial objectives.
Highly organized, detail-oriented, and responsive, with the ability to manage multiple priorities simultaneously.
Intermediate to advanced Microsoft Excel and Word skills required.
Working knowledge of Outlook, Adobe Acrobat, and DocuSign.