Investigator Contracts Lead is responsible for direct site-facing contract and budget negotiations throughout contract execution with assigned clinical investigator sites, including initial agreements and amendments, as well as oversight of other contracting professionals on assigned studies. This role also includes managing the Per-Subject Cost (PSC) process for assigned studies, handling escalation and resolution of budget and non-legal term issues from other ICL or pCRO, and collaborating with other lines to plan site contracting timelines during start-up.
The key responsibilities include:
- Exercising good judgment in balancing Pfizer's risks in making budget and contractual decisions against the potential impact on clinical trial timelines.
- Following GPD processes to develop, negotiate, track, and execute global clinical study agreements with institutions and investigators.
- Developing and overseeing the global site budget process in collaboration with partners.
- Negotiating costs, business, and contractual terms directly with investigators/institutions, making changes within approved legal templates.
- Building and maintaining relationships with key investigational sites and Site Management Organizations.
- Leading study-level site contracting activities, acting as the primary contact for site contracting issues and timelines.
- Partnering with Legal and other divisions to manage escalations and improve processes in site contracting.
- Ensuring alignment with invoicing specialists or service providers regarding site contracting and compensation.
- Applying job skills and procedures to complete assignments of moderate scope and complexity.
- Contributing to major business initiatives or projects, applying technical skills to achieve business objectives.
Basic Qualifications:
- 5+ years of experience in clinical development operations or clinical trial outsourcing, with a bachelor's degree.
- Experience with clinical study budgets and contracting negotiations.
- Knowledge of business, compliance, finance, legal, and drug development principles.
- Strong communication and presentation skills.
- Ability to plan and mitigate risks to site contracting timelines.
- Leadership skills demonstrated through influence rather than authority.
- Experience working in a matrix organization.
Additional Qualifications:
- 2+ years of experience in clinical development or trial outsourcing, plus a US Juris Doctorate or equivalent legal degree.
- Experience drafting and negotiating Clinical Trial Agreements globally.
Work Location: Remote
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