Senior CounselUnited States - California - Santa MonicaLegal & ComplianceRegular
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 chimeric antigen receptors (CARs) for the treatment of hematological malignancies.
The Senior Counsel will support a broad range of business functions across the company but will primarily support the day-to-day contracting needs of the company’s manufacturing and technical operations groups and IT groups. The Senior Counsel will work closely and collaboratively with the Kite sourcing function.
The Senior Counsel, Technical Operations acts as dedicated legal counsel to the Technical Operations and Sourcing function globally. This global role is responsible for advising and collaborating with the business on a broad array of issues related to product development, quality, manufacturing, supply chain, and new product technology. The Senior Counsel, Technical Operations will provide legal support for other departments and areas of the organization.
Responsibilities (include but are not limited to):
- Serve as primary legal support for and a strategic business partner to the Technical Operations functions at Kite. This includes providing solutions-oriented legal advice and counsel in support of both annual and long-term corporate objectives.
- Apply legal expertise, drafting, and negotiation skills to counsel and support Technical Operations functions to effectively manage risks on contractual matters, including drafting, review, and negotiation of legal agreements related to Technical Operations (e.g., logistics, supply, manufacturing and supply, development manufacturing and services, CMOs, outsourcing, IT and quality technical agreements, etc.).
- Proactively identify potential legal risks; formulate and communicate solutions-oriented, compliant, and practical legal advice that meet corporate and Technical Operations’ strategic objectives and priorities.
- Advise stakeholders on the interpretation of applicable laws and regulations, contract interpretation, dispute resolution, IP ownership, data privacy requirements, and other legal matters associated with the company’s business in a manner that provides practical legal advice while properly managing risk to the organization.
- Serve as part of matrixed teams involved in franchise activities and collaborate effectively, find common ground, and build alignment with relevant stakeholders.
- Lead special projects and cross-functional teams that impact the department and business partners, including asset integration.
- Partner with Legal department colleagues in executing and enhancing corporate and department objectives.
- Provide legal support for technical operations aspects of major transactions, including M&A and other business development transactions, including the asset integration implementation of post-closing contracts.
- Coordinate with external counsel as needed on matters within area of responsibility (including the setting of outside counsel budgets and management of associated outside counsel spend),
- Identify the need for new, or updates to existing, policies, procedures, templates, and contract playbooks. Provide legal expertise while partnering with the business and Compliance to develop meaningful and relevant policies, SOPs, and guidance documents.
- Work closely with colleagues to develop templates, playbooks, and processes to support the efficient delivery of legal services in the subject areas of support.
- Liaise with Kite and Gilead attorneys to ensure consistency of templates and contracts policies across the broader organization.
- Create and deliver training and other presentations to business partners and other members of team on legal topics and other relevant subjects.
- Drive increased efficiency, coordination, and effectiveness of legal advice, processes and support to meet the needs of the business and other key stakeholders.
- Keep informed of new laws, regulations, and industry trends to identify any potentials impacts to the organization.
- 20% travel throughout the United States and Europe.
- Juris Doctorate (J.D.) degree from an accredited law school
- Practicing lawyer or solicitor qualified in the US or Europe
- 7+ years of experience in the legal field
- European candidates licensed to practice law in the local region and country the candidate is based in.
- Experience of working extensively with a variety of contracts (including supply contracts), preferably in pharmaceuticals, healthcare or a related industry.
- Knowledge of GMP, ICH, and similar laws and regulations applicable to manufacture of pharmaceutical and biologic products in the U.S. and globally.
- Experienced in advising clients on laws and regulations governing technical operations of the pharmaceutical industry.
- Apply in-depth knowledge of the company, external environment, and industry best practices to analyze and solve issues.
- Demonstrated experience working in a matrixed business environment, managing multiple commitments and clients while prioritizing conflicting demands, maintaining focus on corporate objectives and providing quality customer service.
- Self-motivated, proactive, strategic, and exhibit excellent judgment.
- Ability to understand business priorities, fiscal impacts, and implications and balance legal risks with the need to meet business priorities.
- Ability to conduct thorough and reasoned analysis of complex legal issues and develop creative and effective solutions using in-depth knowledge of the company, relevant laws and regulations, the external environment, and industry best practice.
- Ability to be successful within a fast-paced, evolving environment.
- Possess the ability and willingness to advance new ideas and recognize when decisions may have a broad impact on the global organization.
- Consistently take action and drive issues to closure and hold self and others accountable for achieving results.
- Adept at understanding of the motivation and needs of others and effectively communicating with a diverse audience, including senior leaders, in a manner that generates confidence and support for proposals/recommendations.
- Adept at the ability to develop close, trusting relationships with a diverse set of individuals, characterized by a high-level of collaboration and mutual respect.
- Demonstrates a strong sense of self-awareness and skills to diffuse difficult situations and resolve conflicts.
- Demonstrated experience interpreting and drafting legal documents, including contracts.
- Legal analysis and advice is well thought out and accurate, potential legal and compliance issues are consistently identified, Senior Counsel takes ownership and responsibility for legal issues that arise with the function(s) the Senior Counsel supports.
- Ability to create and deliver effective oral presentations, train, and educate stakeholders and members of the department on legal topics and issues.
- Must consistently demonstrate leadership behaviors and ability.
- Excellent organizational and planning skills, with the ability to handle multiple projects simultaneously.
- Solutions-oriented, pragmatic and proactive in his/her approach to contracting and able to work both collaboratively and autonomously.
- Self-starter; able to work with minimal supervision.
- Exemplary drafting skills.
- Strong interpersonal and communication skills.
- Experience counselling clients regarding risks in the technical operations space.
- Thorough understanding of laws and regulations applicable to manufacturing and supply chain operations for global pharmaceutical companies.