Senior Counsel, Clinical Development (Part-time)
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Overview The Senior Counsel, Clinical Development is a key role responsible for supporting all Xeris clinical development activities, with an initial focus on Xeris's lead pipeline asset. The ideal candidate has significant experience providing legal support for large-scale clinical trials, including drafting and negotiating a wide variety of trial-related agreements. This is an excellent opportunity to contribute to a high-impact legal function on a part-time basis. Responsibilities- Provide direct legal support to Xeris' clinical development team for all clinical development matters, including those relating to the pivotal Phase 3 trial of Xeris' XP-8121 product candidate for the treatment of adults with hypothyroidismand any associated trials (e.g., open-label extension).
- Draft, review, and negotiate a broad range of clinical trial documents and contracts, including clinical trial site agreements, informed consent forms, clinical service provider agreement(s) and amendments, and indemnification agreements.
- Coordinate with CRO(s) and Xeris' clinical development team with respect to site contracting.
- Provide legal guidance on regulatory and compliance issues related to clinical trials, including data privacy and CRO/site/investigator compliance.
- Help manage outside counsel and legal vendors related to clinical trial activities.
- Leverage contract law expertise to provide support in other areas as needed and as workload allows
- Juris Doctor (JD) degree from an accredited law school required
- Is a member in good standing of a state bar association
- Minimum of 5 years supporting large-scale, pivotal clinical trials at a mid- to large-sized law firmand/or established pharmaceutical company
- Capable of handling multiple and competing workloads with changing priorities to meet deadlines
- Able to work independently but know when to involve others or ask for guidance
- Can work effectively with all levels of the organization
- Competencies: Attention to Detail, Highly Organized, Strong Interpersonal Skills, Team Player, Self-Starter, Discrete, Excellent Verbal and Written Communication skills, Customer Service, Time Management
- Working Conditions:
- This is a part-time position, with an expectation of 30 hours of work per week
- Position may require periodic evening and weekend work, as necessary to fulfill obligations.
- This is a remote position, with an expectation of periodic attendance in Xeris' Chicago headquarters. On-site requirements may change at management's discretion.
If you have questions about this posting, please contact [email protected]
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