Consulting Opportunity - Contracts Counsel
- Act as the primary legal contact for the Clinical, Regulatory, Quality, and Translational teams regarding clinical trial-associated contracts.
- Collaborate cross-functionally to ensure alignment on contracting strategy, risk tolerance, and business priorities.
- Draft and negotiate a wide variety of clinical contracts including CTAs, CDAs, Consulting and Advisory Agreements, CRO MSAs and Work Orders, and DPAs, both directly and supported by external counsel.
- Manage external counsel for any outsourced contracts.
- Legal review of other clinical documents, as needed, including ICFs.
- Work collaboratively with clinical CROs and Clinical Operations to align on site contracting strategy.
- JD and 5+ years in house contracts or general corporate experience in a biotech or pharma setting.
- At least 3+ years clinical contracting experience, either directly negotiating clinical contracts or managing clinical contracting as part of a broader role and serving as an escalation point.
- Strong understanding of the key provisions of clinical contracts.
- Ability to produce high quality redlines of clinical contracts with minimal oversight on short turnaround times.
- Experience managing external counsel.
- Experience collaborating cross-functionally with key functions and external collaborators, including Clinical Operations, Regulatory, Finance, and clinical CROs.
- Collaborative, business-minded approach with strong communication and interpersonal skills.
- Experience with phase I trials at an early-stage biotech is strongly preferred.
- Some knowledge of regulatory law is a plus.
- Experience with discovery-phase research and CMC contracts is a plus.
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