Everyone at Kite is grounded by one common goal – curing cancer. Every single day, we seek to establish a direct line between that purpose and our day-to-day work.
We are seeking a highly motivated Senior Vice President, Global Head of Process Development who will report to the Global Head of Technical Operations, and who will be a member of the Technical Operations Leadership Team (TOLT). In this role you will responsible for leading Global Process Development at Kite and will closely collaborate with the Manufacturing, Quality & Compliance, Supply Chain, Facilities & Engineering, CMC Regulatory, Business Operations, IT, HR and Finance functions to ensure the success of Kite Technical Operations.
In addition, you will lead the Process Development Leadership Team (PDLT), which includes Process Design, Analytical Development, Manufacturing Science & Technology (MSAT), CMC Product Life Cycle Management and PD Business Operations. The PDLT provides strategic and operational leadership for Process Development to deliver well-designed robust and scalable manufacturing processes, state-of-the-art and robust analytical methods, automation technologies, scientifically sound specifications and in-process controls, and high-quality regulatory submissions for cell therapies in support of the clinical portfolio and commercial products.
You will also be responsible for forming teams and developing people, and creating an inclusive culture of safety, quality and scientific excellence. The Global Head of Process Development will closely partner with Research and Clinical Development, represent Technical Operations on the Research Scientific Review Committee (RSRC) and participate in the Kite Program & Portfolio Committee (PPC).
Responsibilities include, but are not limited to:
- Strategy – partner with executives from TOLT, Research, Clinical Development and Corporate Development to establish and align on cross-functional strategies and shared global objectives. Lead the PDLT in the development, implementation and execution of scientific strategies, budgets, goals, objectives, etc. to advance the Research, Clinical Development and Corporate Development portfolios, and support commercial manufacturing.
- Global Network – partner with TOLT to complete the construction, start-up, expansion and integration of 3 commercial sites, 2 clinical sites, 1 viral vector site, CMOs, and strategic partners (Daiichi Sankyo, Fosun-Kite) into a fast, flexible and agile global operations network. Oversee product, process and analytical methods, and relevant internal and external activities from bench to GMP manufacturing.
- Commercial Supply - collaborate with Quality & Compliance, Supply Chain, Manufacturing to ensure that both internal and external site operations are appropriately supported by Global MSAT to safely, compliantly, effectively and efficiently meet global demand and financial targets.
- Clinical Supply – in close partnership with Research, Clinical Development, Manufacturing, Clinical Quality and CMC Regulatory, ensure the rapid advancement of pre-clinical and clinical programs by delivering processes and assays for a broad array of autologous and allogenic cell therapy modalities, e.g. CAR T-Cells (iPSC derived, bispecific), engineered TCR T-Cells (public and private antigens, including neoantigens), NK Cells, etc. as well as various gene transfer and gene editing modalities.
- Compliance - collaborate with Quality & Compliance, CMC Regulatory and Facilities & Engineering to maintain a high level of cGMP, regulatory and safety compliance through the effective monitoring and reporting of key data and driving continuous improvement.
- Technology – provide process and analytical method development expertise and closely collaborate with Research, Clinical Development and Corporate Development to assess new scientific technologies, continually monitor the competitive landscape and evaluate external innovation opportunities that enable development of transformational cell therapy treatments. Drive scientific rigor and enhance process and analytical method knowledge across all operations. Lead the development of manufacturing platforms, and innovation of novel manufacturing and analytical technologies.
- Continuous Improvement – partner with Manufacturing and Quality to ensure process and analytical method alignment and drive product/process improvements to improve reliability, quality, productivity and efficiency. Cultivate an open, inclusive and “speak-up” environment to ensure that the best innovative solutions are identified and implemented.
- Talent Development – collaborate with HR to attract, build and develop an inclusive diverse high performing leadership team, develop the next generation of scientific leaders through empowerment, creating a feedback rich culture, ensuring effective personal development of leaders, and building a strong succession pipeline.
- Education – PhD in a relevant scientific field such as Immunology, Bio Medical Engineering, Biochemistry, Molecular Biology, etc., MBA preferred.
- Experience - at least 20 years of pre-clinical, clinical and commercial stage experience in biologics, cell and/or gene therapy process development; preferably with 10+ years of senior leadership experience; experience managing high-performing technical managers and scientists, and leading cross-functional process development teams with 5+ years leading cell culture teams; direct experience in GMP clinical and commercial biologics manufacturing operations preferred.
- Entrepreneurial - high energy level with a positive “can do” attitude, ability to adapt and think “out of the box” and rapidly turn ideas into action in a nascent, evolving, innovative industry. Manage ambiguity with aplomb and calmness. Other traits include creativity, innovation and risk-taking and ambiguity.
- Enterprise Leadership - ability to build inclusion, empowerment and accountability across teams and functions by being bold in aspiration and agile in execution, making time for people, listening, speaking openly and explaining the “why”, believing in others and oneself to make sound decisions, and owning the impact of one’s words and actions.
- Drug Development - understands product life cycle management from pre-clinical through commercialization, and how to translate innovative pre-clinical processes and assays into CMC regulatory strategy to gain Health Authority approval and advance the pipeline.
- International Mindset – previous regional and global responsibility, international assignment preferred. Experience leading global functions, domestic and/or international teams.
- Interpersonal Skills – vulnerable, humble, confident, courageous. Ability to give and earn trust. High level of emotional intelligence, exceptional listening, verbal and written communication skills.
- Decision Making - proven ability to think critically and make objective, inclusive, robust and unbiased decisions with imperfect information. Proven scientific and analytical problem solving of complex problems. Ability to adopt other people’s point of view - especially if different than one’s own, delegate and empower effectively.
- Collaboration – multi-functional, corporate and site experience with a focus on bringing varied perspectives together, sharing standard methodologies, and effectively using resources in an inclusive manner to further Kite’s enterprise strategy and achieve Technical Operation’s objectives. Thoughtfully and effectively represent Process Development at TOLT and various Kite governance bodies.
- Change Management - effective Sponsorship, Change Agent and influencing skills. Adaptive, agile, flexible, open minded. Proven ability to build cross-functional commitment, lead, simplify and scale complex dynamic organizations through transformational change.
- Business Acumen - broad understanding of the business model, science, facilities, engineering, process development, supply chain, quality, compliance, regulatory, and information technology expectations for cell therapy and ability to utilize that understanding to further enhance Kite’s leadership in cell therapy.