Senior Cell Therapy Legal Counsel - International

Gilead Sciences, Inc. ,
Uxbridge, Greater London

Overview

Job Description

**For Current Kite Pharma Employees and Contractors:** Please log onto your Internal Career Site at to apply for this job **Job Description** Kite, a Gilead Company, is a biopharmaceutical company focused on the development and commercialization of novel cancer immunotherapy products designed to harness the power of a patient's own immune system to selectively target and kill cancer cells. Our core technology involves the genetic engineering of T cells, or white blood cells, to express either chimeric antigen receptors (CARs) or T cell receptors (TCRs) for the treatment of advanced solid and hematological malignancies. The legal department at Kite is seeking a senior-level attorney to serve as its lead counsel for all commercial territories outside the US. This position will be based at Gilead's European headquarters in Stockley Park, UK and will report to the VP of Legal at Kite in Santa Monica, California. This role will oversee all legal and compliance aspects of Kite's cell therapy business in Europe, including support for Commercial, Medical Affairs, Regulatory, Market Access, Government Affairs, Public Affairs, Clinical Development, Safety and Pharmacovigilance, and Tech Ops which includes Manufacturing, Supply Chain and Quality. This attorney will manage at least two attorneys in Stockley Park and one in Amsterdam, and will liaise with the Kite legal team in Santa Monica and with Gilead lawyers located at Gilead's affiliates throughout Europe and elsewhere, including Australia and Canada. This role may also be responsible for helping to ensure that Kite is providing an appropriate level of commercial legal and compliance support for Kite's commercial partner in Japan and for the company's joint venture in China. This is an exciting opportunity for an experienced attorney with strong leadership skills and an ability to provide strategic advice and counsel to senior executives in a rapidly-growing cell therapy business unit. **Responsibilities for this position will include the following:** + Provide legal and compliance support for all aspects of Kite's European cell therapy business + Advise the European Commercial, Medical Affairs, Market Access, Public Affairs, Government Affairs, Clinical Development, Manufacturing and Tech Ops teams on all legal and compliance issues affecting the business + Develop and enhance policies and procedures to ensure the Kite cell therapy business in all ex-US territories is operating in a manner which is fully compliant with applicable laws and regulations and consistent with the policies and procedures existing at Gilead, partnering with local affiliate counsel as needed + Partner with the business to proactively identify and mitigate areas of potential risk, many of which will be novel and unique to cell therapy + Advise on applicable medicines and biopharmaceutical laws, rules, regulations and Codes of Practice, including those focused on Advanced Therapy Medicinal Products, marketing authorizations, the processing of human cells and tissues, advertising and promotion, anti-bribery and corruption, financial interactions with healthcare providers, and data privacy and freedom of information + Draft, review and negotiate various agreements in support of the foregoing + Provide strategic legal counsel and advice to the Kite European Leadership Team (KELT) + Provide legal and compliance advice and support to Gilead Affiliates that are either commercializing or preparing to commercialize Kite's product(s), potentially including Kite's strategic alliance partners in certain markets where commercial rights have been granted to third parties, including Japan and China + Liaise and coordinate with the Kite legal team based in Santa Monica, and also with the Gilead legal teams based in California and the UK whenever appropriate to ensure consistency and generate efficiency + Collaborate closely with Gilead specialist legal teams in Europe and elsewhere, such as Gilead's European Competition Counsel, the Contracts, Operations and Distributors group, and IP to deliver consistent advice + Ensure that the Kite Amsterdam organization including the local manufacturing facilities are provided with appropriate legal support and that their compliance obligations are met + Serve as a member of both the Kite Legal Leadership Team, and the Gilead European Legal Leadership Team + Work collaboratively with the broader Gilead Legal Department, senior leaders and client groups at Gilead's headquarters in Foster City, California and with Gilead's affiliates and subsidiaries around the globe **Requirements for the position include the following:** + An upper second class law degree or other undergraduate degree with post graduate legal qualifications in the UK (or other equivalent in another European jurisdiction) + Current practicing certificate from the Solicitors Regulation Authority, member of the Bar (or equivalent in another European jurisdiction) + Demonstrable experience within the ph