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Oncology is a key therapeutic area for AbbVie, with a portfolio consisting of three marketed products — Imbruvica, Venclexta, and Empliciti — and a pipeline containing multiple promising new molecules that are being studied in nearly 200 clinical trials in 19 different types of cancer.
AbbVie is expanding its oncology hub on the West Coast, with three sites in the San Francisco Bay Area (Redwood City, South San Francisco, and Sunnyvale) focused on the discovery and development of novel oncology therapies. More than 1,000 AbbVie scientists, clinicians, and product developers with strong entrepreneurial roots work across these three sites. They combine their expertise in immuno-oncology, stem cells, and cell-signaling with their knowledge of bispecific antibodies, antibody -drug conjugates (ADCs), and covalent-inhibitor technologies to discover and develop novel cancer treatments. This position will be based at AbbVie Stemcentrx, AbbVie's location in South San Francisco, CA.
As part of a talented and multi-disciplinary team advancing exciting new approaches to oncology drug discovery and development, AbbVie Stemcentrx is seeking an energetic and creative attorney who enjoys learning new things in a fast paced environment. The Clinical R&D Counsel will collaborate with other legal professionals and staff supporting the company’s clinical trial operations and contracting process. The successful candidate will be responsible for identifying and resolving complex and significant legal issues related to pharmaceutical clinical research, development, and clinical collaborations – for compliance with applicable corporate policies and procedures, in addition to negotiating and executing routine operational agreements. The ideal candidate must be energized by working in a complex and fast-paced environment, be able to quickly understand and support business objectives with creative and strategic approaches, collaborate with members of AbbVie’s R&D Legal team, all while exercising sound and ethical judgment
Draft, negotiate and interpret a range of complex clinical R&D related agreements, including clinical study agreements with clinical trial sites and investigators, consulting agreements, CRO (Contract Research Organization) agreements and clinical services agreements, clinical research collaborations, and other ancillary agreements for clinical trial support.
Support and collaborate with other legal professionals and staff within the R&D Legal team.
Develop strategies and provide legal advice to support optimal outcomes for the business.
Work cross-functionally with various departments to meet business objectives related to clinical research.
Serve as the designated Clinical R&D Counsel representative for the AbbVie Stemcentrx research site for legal matters related to internal and external clinical research planning and execution.
Assist AbbVie’s Division Counsel, Clinical R&D and other AbbVie counsel and paralegals on the R&D Legal team on matters of significant importance.
Provide input in the development and implementation of policies and procedures.
In conjunction with various non-legal contracting functions, address and provide legal advice as required to support clinical research needs.
Understand AbbVie Stemcentrx’s clinical programs in the context of AbbVie’s overall oncology portfolio.
Be committed to meeting unmet patient needs and be energized by confronting new challenges.
Be energized by challenging and interesting legal work and novel business problems.
Be able to work cross–functionally to develop solutions to support business objectives.
Stay abreast of changes in laws that affect R&D clients and clinical studies, and apply knowledge of U.S. laws and regulations (including False Claims Act, Anti-Kickback Statute and safe harbors, the U.S. Sunshine Act, FCPA) as well as industry guidance impacting clinical research.
Be capable of regularly negotiating independently with clinical research sites and partners on matters of strategic importance that affect AbbVie’s R&D business.
Clearly define project objectives with capable management.
Identify unmet needs and future legal issues and proactively propose strategies to optimize outcomes and results for the company and manage risk.
Have excellent drafting, negotiation and very clear communication skills.
Have the ability to prioritize and manage multiple projects.
EDUCATION/ EXPERIENCE/ QUALIFICATIONS:
3-5 years of legal practice including contract negotiation and drafting, preferably with clinical research contracts and preferably in an industry setting.
At AbbVie, we have the expertise of a proven pharmaceutical leader and the focus and passion of an entrepreneur and innovator. The result is something rare in health care today – a global biopharmaceutical company that has the ability to discover and advance innovative therapies and meet the health needs of people and societies around the globe.