Senior Manager, Grants and Contracts

New Haven, CT, USA|Onsite

Job Overview

Compensation

Salary

Range $148,156.00 - $173,480.00

Work Schedule

Flexible

Benefits

401(k)

401(k) matching

Dental Insurance

flexible schedule

Flexible spending account

Health Insurance

Health savings account

Life insurance

Paid Time Off

Professional development assistance

Tuition Reimbursement

Vision Insurance

Job Description

Celldex is a pioneering biotechnology company that focuses on the development of innovative antibody-based therapies aimed at harnessing the power of the human immune system. Dedicated to improving the lives of patients suffering from allergic, inflammatory, and autoimmune disorders, Celldex operates at the forefront of immunology research and clinical development. The company fosters a highly entrepreneurial and supportive culture where innovative and talented professionals thrive. Employees are valued for their passion and motivation to make a real difference in the lives of people facing serious health conditions, and this commitment is seen as both a personal and professional reward.

Celldex invests significantly in attracting and retaining top talent, creating an environment where professional growth and development happen continuously. The company’s collaborative and empowering work culture supports employees in expanding their skillsets while contributing meaningfully to cutting-edge advancements in medical treatments. As a global leader in the biotech industry, Celldex offers opportunities to work alongside experts in various domains, contributing to life-changing therapies that address unmet medical needs.

The Sr. Manager, Grants and Contracts is a critical leadership role within Celldex’s clinical development framework. This position is responsible for managing and leading sophisticated clinical contracting and budgeting activities that underpin Celldex’s global clinical trials and studies. The role serves as a strategic liaison to several departments, including Clinical Operations, Legal, Finance, and Procurement, as well as collaborating with external partners such as clinical research organizations and vendor entities. The focus is on ensuring the efficient, timely, and compliant negotiation, execution, and management of clinical site agreements, budgets, and vendor contracts.

This role demands a high level of autonomy and responsibility, expecting the incumbent to drive contract negotiations independently while balancing operational objectives, financial constraints, compliance mandates, and risk mitigation. The Sr. Manager is expected to proactively identify potential challenges, develop well-informed recommendations, and resolve issues efficiently without frequent escalations. The position involves significant involvement in clinical site budget negotiations and vendor contract management, contributing to the seamless progression of clinical trials.

Additionally, the Sr. Manager acts as a trusted advisor within the organization, providing sound judgment and strategic direction under complex dynamic situations. This person also functions as a backup to the Associate Director, ensuring continuous leadership support and decision-making. The role is ideal for someone who thrives in collaborative, fast-paced environments and is passionate about supporting innovative clinical research efforts with critical business and legal acumen.

Employment type for this position is full-time and the salary range is competitive, between $148,156 and $173,480 annually, supplemented by performance bonuses and long-term incentives. The comprehensive benefits package includes health insurance, dental and vision coverage, life insurance, flexible spending accounts, retirement plans with employer contributions, paid time off, and professional development opportunities including tuition reimbursement. Located on-site to closely work with cross-functional teams and external partners, this position offers a unique chance to contribute to the mission of developing transformative therapies for patients worldwide.

Job Requirements

Bachelor's degree or equivalent combination of education and relevant experience
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
Strong preference for experience negotiating global contracts and budgets
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
Intermediate to advanced Microsoft Excel and Word skills required
Working knowledge of Outlook, Adobe Acrobat, and DocuSign

Job Qualifications

Bachelor's degree or equivalent combination of education and relevant experience
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

Job Duties

Owns the end-to-end negotiation of global clinical trial agreements (CTAs) site budgets and ancillary documents, whether managing directly or via a CRO
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
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
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
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
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 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