Senior Counsel (Cell Therapy) Kite Pharma ACE
Senior Counsel (Cell Therapy) Kite Pharma ACE
United Kingdom - Uxbridge
Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gileads therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
Making an impact on a global scale
Inclusion is one of the companys five core values. Thats because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.
When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible
This is an exciting opportunity to join a developing in-house legal team working on a broad range of legal and compliance issues in a fast-paced environment in which delivering innovative cell-therapy products to the very sick patients who need them creates novel challenges almost daily. The Kite ACE Legal team is a critical part of Kite's Global Legal function and supports all Kite's enterprise-wide activities and infrastructure (including clinical research, manufacturing, logistics, sales & marketing, medical affairs, public affairs and government affairs) in the ACE region as well as counselling all the other support functions which make up Kite's ACE organization.
The Senior Cell Therapy Counsel will provide legal support to Kite ACE. The role requires a technically strong and pragmatic lawyer with a track-record as a successful business partner and effective cross-functional operator who is also able to demonstrate professional objectivity and independence when necessary.
The position is Associate Director/Director Level and will report into the Head of Kite ACE Legal.
Job duties include:
- Provide expert healthcare compliance advice across the business with emphasis on the laws, regulations, codes and policies relating to promotion and advertising of medicines so as to ensure compliance with those laws etc. and maintain a balanced ethical approach to risk. These include without limitation EU and national medicines advertising laws, regulations and codes of practice (e.g. IFPMA, EFPIA, ABPI, PhRMA), UK Bribery Act, FCPA and other anti-bribery and anti- corruption laws; financial interactions with healthcare professionals/public officials (e.g. speaker programs, advisory boards, congress sponsorships) ; interactions with patients; and data privacy and freedom of information. In particular:
- Deliver timely advice on aspects of the Cell Therapy business model to various business functions to ensure the model is developed and executed in a manner which is fully compliant with applicable laws and regulations and with Kite/Gilead Policy (including the Gilead ACE business conduct manual and associated procedures);
- Review and engage on day-to-day activities across business functions including Commercial (Marketing), Medical Affairs, Market Access, Public Affairs and Government Affairs to identify and address legal and compliance issues;
- Ensure a high degree of understanding within the Cell Therapy BU of the legal and compliance requirements and the context of those requirements, and work with the business to proactively identify and mitigate areas of potential risk;
- Support the Head of Kite Legal ACE, and Kite/Gilead Regulatory Law counsel as necessary, with counselling on Kite issues relating to medicines /biopharmaceutical laws and regulations, including those focused on: Advanced Therapy Medicinal Products; orphan-designated medicinal products; marketing authorisations, risk mitigation plans; processing of human cells/tissues; and applicable GxPs;
- Maintain, develop and adapt the matrix of agreements and contract templates (e.g. Supply Agreements, Quality Agreements etc) underpinning Kite's ACE business model, train and equip Gilead affiliate Kite-designated lawyers to deploy these agreements in their countries; and provide such guidance on this subject as is necessary in Kite's manufacturing plant in Amsterdam. Draft, review and negotiate certain intra-company and third-party agreements;
- Develop an in-depth understanding of cell-therapy and Kite's business (disease biology, scientific data, clinical practice, manufacturing process, logistics, site qualification, the Kite Konnect platform, health economics, pricing and reimbursement; and political or other environmental factors);
- Provide operational legal oversight of the manufacturing facility in Amsterdam (together with an on-site contracted attorney) and develop a solid working relationship with the Tech Ops organization generally;
- Lead continuing development of Kite Legal's working relations with the Gilead GTAL and Compliance teams, and with Gilead Regional Counsel and Affiliate counsel to ensure consistency in advice and practice across the ACE region, identify efficiencies where practical and ensure this relationship is mutually beneficial to the business;
- Engage and participate as a member of the Global Kite Legal team and establish lines of communication with the Santa Monica-based attorneys, compliance professionals and staff (Corporate, Commercial, Compliance, Litigation & Investigations and IP) to facilitate team working as needed;
- Collaborate with specialist Gilead ACE attorneys (Competition Law, Regulatory Law, Centre of Excellence, IP, Privacy and Information Governance) as needed to deliver comprehensive legal support to the cell-therapy business;
- Maintain and update Kite ACE's legal and business conduct policies and practices based on industry best practices, and communicate Kite's needs and contribute Kite's perspectives to policy initiatives developed by Gilead ACE's Legal and Compliance teams to ensure that the particular characteristics of cell-therapy are understood and incorporated in broader corporate initiatives and policies;
- Create and deliver legal and healthcare compliance training across the Kite ACE business tailored as appropriate to the intended audience (e.g. Sales, Marketing, Medical, Market Access, Manufacturing & Quality);
- Provide primary legal and compliance support to the team designing, building, operating and developing the Kite Konnect platform and eco-system;
- Support the Kite ACE Head of Legal and deputize for her/him as necessary
Knowledge, Experience and Skills
- An upper second class undergraduate degree in law or in science (or another subject) together with applicable post-graduate legal and vocational training;
- Current practicing certificate from the Solicitors Regulation Authority or member of the Bar (UK jurisdictions) or equivalent professional qualification to practice law in another European jurisdiction;
- Demonstrable experience gained within the pharmaceutical or biotechnology industry and/or significant law firm experience advising clients within the life sciences sector;
- Strong and up to date knowledge of EU medicines/biopharmaceuticals laws, regulations, codes of practice and best practices;
- Preferably management experience including substantial project management leading multi-country teams and projects;
- Ability to identify legal and compliance risk and provide timely and appropriate advice is response;
- Excellent verbal and written communication skills including the ability to present complex information in a succinct, accurate and persuasive manner to all levels of the business;
- Proven experience of developing policies, procedures and processes that help the business to comply with laws, regulations and codes and drive for consistency.
Excellent oral and written English language skills is a prerequisite and additional European language skills are an advantage.
- Ability to work autonomously with high mental agility, including the ability to prioritise workload and operate within a fast-paced business environment.
- Ability to build relationships and influence at all levels, demonstrating a flexible approach to connect with colleagues in the broader organisation and engage with multiple stakeholders to drive projects and cultural change across a matrix environment.
- Excellent communication skills and the ability to develop and provide clear direction to the business and pragmatic solutions to complex legal & compliance challenges.
- Sound judgment, combined with the self-confidence and gravitas to identify, assess and control legal and compliance risk and deliver recommendations and effective advice on diverse legal and business matters.
- Ability to partner with business teams but also provide independent counsel.
- Ability to rapidly analyse legal risks and provide expertise and contribute effectively to cross functional project teams.
- Ability to manage external counsel, building effective relationships and monitor legal spend.
- Demonstrable organisational skills and high attention to detail, coupled with a keen understanding of the importance of structure and process
- Well-developed IT skills
- Resilient individual
- Ability to engage and manage multiple stakeholders to achieve the objective
- Curious with learning agility
- Operationally excellent
- Organised with a systematic approach to prioritisation
- Process-orientated to achieve the business objective
Gilead Core Values
- Accountability (taking personal responsibility)
- Excellence (working at a high level of commitment and capability)
- Inclusion (encouraging diversity)
- Integrity (always doing the right thing)
- Teamwork (collaborating in good faith)
Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system\'s ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit www.kitepharma.com. Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma.
Equal Employment Opportunity (EEO)
It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual's gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.
For Current Kite Pharma Employees and Contractors:
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