Overview
This role is responsible for moving critical clinical contracting and budgeting activities forward efficiently and strategically to deliver agreements that support Celldex’s business objectives. This role will report to the Associate Director, Grants and Contracts.
Responsibilities
- Owns the end-to-end negotiation of global Clinical Trial Agreements (CTAs) and budgets, 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.
- Independently leads the negotiation and execution of other initial or amended clinical Agreements such as Investigator Initiated Research Agreements (IIRs), Confidential Disclosure Agreements (CDAs), Consulting Agreements, as well as Vendor Agreements such as Master Services Agreements (MSAs), Statements of Work (SOWs), and Change Orders (COs).
- Partners with data privacy stakeholders to negotiate and execute Data Processing/ Protection Agreements (DPAs) consistent with GDPR and global privacy standards.
- Oversees CRO development of, and leads internal review/approval of, country-specific site CTA, budget, and other ancillary templates for global Clinical Studies.
- Works closely with CRO partners to drive clarity, speed, and quality.
- Acts as the central communicator between legal, study teams, finance, and operations to ensure assigned contracts are aligned cross-functionally and in full compliance with Celldex standards.
- Takes ownership of tracking, reporting, and reconciling contract and budget progress, ensuring visibility across teams and proactive risk mitigation, and maintains supporting documentation including contract repository maintenance and oversight.
- Gathers, populates, and oversees the review of monthly accrual data for assigned clinical studies and liaises with Clinical Operations and Finance to ensure accurate financial reporting with supporting documentation. Delivers rationale for study-specific approaches in collaboration with team.
- Represents the contracts function in cross-functional meetings as a trusted collaborator who anticipates needs, identifies gaps, and proposes actionable solutions to deliver assignments in alignment with company goals. Tracks any MGC action items and moves them forward until completion.
- Supports departmental review of internal contract or budget templates or MGC processes and provides input and suggestions to enhance productivity and quality.
- If assigned, supports clinical team in vendor selection/RFP process.
- If assigned, populates site payment data for studies not outsourced to a CRO, and/or reconciling internally or externally managed final site payments.
- If assigned, supports department management with key objectives such as contract system database oversight, KPI oversight and improvement.
Qualifications
- Bachelor’s Degree or a combination of relevant education and experience
- At least 3 years relevant experience directly negotiating clinical site CTAs, budgets and vendor contracts
- Strong preference for experience negotiating ex-US contracts and budgets
- 4+ years in a clinical development or clinical operations team with a pharmaceutical company, CRO, or investigator site
- Experience with GDPR guidance and managing data privacy terms a plus
- Understanding of healthcare compliance and other relevant guidance including GCP, HIPAA, FCPA
- Intermediate level Excel and Word skills required
- Working knowledge of Outlook, Adobe Acrobat and DocuSign
- Experience with Teams, Smartsheet, or contracts database/repository a plus
- Adept at navigating complexity, prioritizing competing demands, and driving initiatives to completion without losing sight of strategic goals
- Advanced communication and relationship-building skills; able to influence and engage others across functions and geographies
- Demonstrated ability to interpret, consolidate, and reconcile multi-stakeholder feedback into cohesive contract language
- Excellent analytical and problem-solving skills, takes ownership of assignments and initiative to move tasks forward and propose solutions to obstacles
- Highly organized, detail-oriented, and responsive, yet flexible and adaptable when navigating ambiguity
- Ability and interest to learn, grow, and adapt
Compensation
The expected base salary range for this position is $116,156 to $173,480.
We are committed to compensating employees equitably based on several factors including experience, education, licensure/certifications, skill level, location of the position, and availability of similar talent in a competitive market.
Compensation for this role includes base salary, annual discretionary bonus, long term incentive, 401(K) plan with employer contribution, health care and other insurance benefits (for employee and family), paid holidays, vacation, and sick days. A summary of our benefits can be found on our careers page.
Pay: $116,156.00 - $173,480.00 per year
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
Work Location: In person
