Description:
An American Biopharmaceutical Company Corporate Legal Group is seeking an attorney who thrives in a high-volume, fast-paced, high-performing and collaborative corporate environment. This individual will work within An American Biopharmaceutical Company Clinical Legal team, which is responsible for the review, negotiation and management of a variety of agreements in support of An American Biopharmaceutical Company clinical trials. This individual will be part of a five-person team spread out across the U.S. and will report to the Clinical Legal team lead. This role will preferably be based on-site in An American Biopharmaceutical Company offices in Foster City (CA) or Parsippany (NJ) with a requirement to come into the office at least three times per week. Remote candidates outside of those areas may be considered.Specific Responsibilities:
- Review and negotiate day-to-day Company agreements including global clinical trial agreements (“CTAs”), investigator sponsored research agreements, confidentiality, consulting and miscellaneous vendor agreements for a broad range of clients.
- Draft, review and negotiate these agreements, handling all routine issues and consulting with attorneys in the group when complex legal questions arise.
- Advise stakeholders and train internal clients on contract forms and procedures.
- Provide guidance and support to Contracts Specialists within the group.
- Create resources to ensure internal compliance with Company processes.
Education & Experience Requirements:
- Bachelor's degree, Juris Doctorate and hold active bar license in at least one state.
- Experience should include drafting and negotiating clinical contracts in a bio-pharma company, university or Contract Research Organization.
- 4+ years experience drafting and negotiating clinical trial agreements in a variety of countries.
- Experience with or knowledge of Pharma contract issues that overlap with FDA regulations.
- Experience collaborating with government agencies and non-profits.
- Experience with or knowledge of data privacy laws foreign (e.g. GDPR) and domestic.
- Experience with or knowledge of intellectual property contract issues.
- The ideal candidate will be flexible and willing to learn new procedures and skill sets.
- Must have excellent organizational skills, attention to detail and the ability to perform in a fast-paced, deadline-driven environment.
- Creative and solution-driven mindset.
- Ability to multi-task and handle multiple contract negotiations simultaneously.
- Must be able to set and appropriately modify priorities with internal clients on an ongoing basis and manage client and third party expectations.
- Must be capable of analyzing legal issues and have comfort in advising client groups on various legal issues related to contracting.
- Ability to work independently and as part of a team.
- Must be able to collaborate and work with other departments such as Clinical Operations, Clinical Development, Risk Management, Regulatory, and Compliance.
- Strong oral and written communication skills.
