Director, Legal - Singapore - GILEAD SCIENCES SINGAPORE PTE. LTD.

GILEAD SCIENCES SINGAPORE PTE. LTD.
GILEAD SCIENCES SINGAPORE PTE. LTD.
Verified Company
Singapore

1 week ago

Wei Jie

Posted by:

Wei Jie

beBee Recruiter
Description
**Senior Counsel, Kite Legal ACE (Australia, Canada, Europe) & INT (International)

The Position


This is an exciting opportunity to join the in-house legal team of Kite Pharma, a Gilead Sciences company, which is one of the of the global leaders in the innovative cell-therapy business.

You will be working on a broad range of interesting legal and compliance issues in a fast-paced environment. Gilead and Kite are expanding its cell therapy business in new markets internationally. This role will specifically support our cell therapy business in the Asia region.


The Kite ACE/INT 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, market access, public affairs and government affairs) in the ACE and INT region.

This is a matrix role which involves cooperation with and support of the legal colleagues at the Gilead affiliates which are marketing Kite's cell therapy products OUS.


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 will report into the Head of Kite Legal ACE/INT. The location of the position is Singapore.


Job duties include:


Provide expert healthcare compliance and legal advice across the business with emphasis on the laws, regulations, codes and policies relating to the manufacture, sale, promotion and advertising of Advanced Therapy Medicinal Products (ATMPs) so as to ensure compliance with those laws and regulations and maintain a balanced ethical approach to risk.

These include global and national, notably Singapore and/or other Asian country, medicines laws and regulations including specific laws and regulations on ATMPs, advertising laws, regulations and codes of practice (e.g. SAPI, IFPMA, PhRMA), UK Bribery Act, FCPA and other anti-bribery and anti
- corruption laws.


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 applicable Kite/Gilead policies, business conduct manuals and associated procedures;
  • Review and engage on daytoday activities across regional business functions including Commercial (Marketing), Medical Affairs, Market Access, Public Affairs and Government Affairs to identify and address legal and compliance issues of regional activities in relation to Kite's cell therapy products;
  • Ensure a high degree of understanding within the regional cell therapy team 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/INT, and Kite/Gilead Regulatory Law counsel as necessary, with counselling on cell therapy product issues relating to biopharmaceutical laws and regulations, including those focused on ATMPs, orphandesignated medicinal products, marketing authorisations, risk mitigation plans, processing of human cells/tissues, Medical Device laws, and applicable GxPs;
  • Maintain, develop and adapt the matrix of agreements and contract templates (e.g. Supply Agreements, CDA, Distribution Agreements) underpinning the cell therapy business model, train and equip Gilead affiliate cell therapydesignated lawyers to deploy the agreements in their countries;
  • Develop an indepth understanding of celltherapy and Kite's business (disease biology, scientific data, clinical practice, manufacturing process, logistics, site qualification, the Kite Konnect platform, health economics, pricing and reimbursement of ATMPs; and political or other environmental factors);
  • Support the 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/INT 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 USbased attorneys, compliance professionals and staff (Corporate, Commercial, Compliance, Litigation & Investigations, IP, Tech Ops, R&D, Clin Dev) to facilitate team working and best practice sharing as needed;
  • Collaborate with specialist Gilead attorneys (e.g. Competition Law, Regulatory Law, Centre of Excellence, IP, Privacy and Information Governance) as needed to deliver comprehensive legal support to the celltherapy business;
  • Maintain and update Kite ACE's and INT's legal and business conduct policies and practices based on industry
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