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Executive Director, CMC Team Leader (CTL)

United States - California - Santa Monica, United States - Maryland - FrederickProcess/Product Development & OperationsRegular

Job Description

Kite is seeking a highly motivated Executive Director, CMC Team Leader (CTL) with excellent leadership and communication skills, and extensive experience in cell therapy CMC strategy and product development for our late-stage, autologous CART program in collaboration with an external partner.

The Executive Director, CTL will lead a cross-functional CMC Team (CT) and work closely with Kite Tech Ops Leadership Team (TOLT) and our external partner to develop a competitive and comprehensive CMC product development strategy to maximize the value of the product in compliance with the contractual terms. He/she will devise a detailed, well-thought-out CMC plan including manufacturing, supply and regulatory strategy, risk management and timelines etc.

In addition to development of the CMC strategy, the Executive Director, CTL will oversee the planning and execution of the strategy to support the commercialization of the product and life cycle management. Using standardized program management tools, the Executive Director, CTL will be responsible for maintaining alignment with internal and external cross-functional key stakeholders and PT on CMC timelines and deliverables. The CTL reports out regularly to the Technical Operations Leadership Team (TOLT) and other key stakeholders on status of CT goals, deliverables, and timelines and proactively and quickly communicates risks, escalates issues and overcomes hurdles.

The Executive Director, CTL will represent Technical Operations as a key member on the Product Team (PT) and collaborate cross-functionally with other PT members from Clinical, Commercial and other functions to develop the overarching product strategy. He/she provides an in-depth understanding of autologous cell therapy drug development processes and ensures all CMC aspects and risks are carefully considered cross-functionally as part of the program and product commercialization strategy.

Reporting to the Vice President, Head of CMC Product Strategy (CPS) within PD, the Executive Director, CTL is a member of the CPS Senior Leadership Team (CPS SLT). He/she is responsible to advance product development through CMC commercialization and internal and external governance process, continuously improve CMC Team operating model and collaborate seamlessly with other CPS functions (CMC Project Management, CMC Regulatory Writing and CMC Product Business Analytics) and PD functions (Process Design, Analytical and Manufacturing Sciences and Technology).

There is a 50% travel requirement for this position. The position can be based in Kite’s headquarters in Santa Monica, California or Fredrick, Maryland.

Key Responsibilities including but not limiting to:

  • Develop comprehensive, integrated CMC product strategy and plan documents, inclusive of detailed assessment, option analysis, timelines, and risk management in all aspects of CMC development for the program, through leading the cross-functional CMC Team
  • Manage interfaces and deliverables with external partners and CDMOs in compliance with contract terms and CMC strategy
  • Coach and mentor CMC Team Members (CTMs), resolve conflicts and create a high-performance team culture and identify opportunities for team members to grow as leaders
  • Advance CMC product development through stage gate reviews, communicate risks, escalate issues and remove hurdles with key stakeholders quickly and effectively, following the proper governance process internally and externally
  • Oversee the implementation and executive of the CMC strategy and plan in aligned, coordinated, and efficient fashion
  • Develop, implement, and track progress of CMC Team goals, deliverables, timelines, and dashboards
  • Integrate innovative and improved methods, processes, and technology into the product strategy to maximize product value
  • Organize and lead cross-functional workshops if needed to develop and analyze scenarios, make decisions, or synthesize recommendations
  • Represent Technical Operations at the Product Team and collaborate cross-functionally with other Product Team members; ensure alignment of Product Team on CMC strategy, timelines, and deliverables; act as an advocate for the product and deliver to product goals through CMC excellence and initiatives
  • Contribute to the development and continuous improvements of core CPS business processes, including CMC Team operating model, governance, regulatory submissions and financial planning to maximize CMC Team effectiveness and efficiency in the matrixed environment

Basic Qualifications:

  • PhD with 12+ years or MS/MBA with 12+ years or bachelor’s degree with 14+ years of experience with of biotechnology or pharmaceutical industry experience

Preferred Qualifications

  • 10+ years of experience leading functional or cross-functional teams/programs within key CMC functions (e.g., Process Development, Manufacturing, Quality, Supply Chain and Regulatory CMC)
  • Prior experience in cell therapy CMC product development, commercialization, and life cycle management
  • Prior experience in external partnership and CDMO management
  • Prior experience in leading high-performing cross-functional CMC teams with demonstrated leadership and collaboration skills
  • Excellent communication, influencing skills and ability to deal with ambiguity and change
  • Excellent presentation skills to different audiences, including to senior management
  • Ability to provide vision, coach performance, resolve conflicts and provide balanced feedback to inspire team members and maximize team productivity
  • Excellent emotional intelligence to navigate and influence effectively in complex, matrixed team and governance structures both internally and externally
  • Open-minded, agile and flexible to be able to pivot rapidly as needed
  • Ability to quickly learn, digest, synthesis and communicate information through relevant business and option analyses to influence and drive decision-making
  • Ability to recognize strategic implications of complex product development activities, effectively prioritize and manage multiple major deliverables in parallel cross-functionally
  • Prior experience in external partnership relationships and governance process
  • Ability to travel ~50% of the time
  • Additional diverse assignments/experiences in alliance management, contract manufacturing, corporate development, strategic planning, business analysis, program management, and regulatory affairs etc.