Director, Head of CMC Portfolio and Program Management

Job Description

 We are seeking a highly motivated individual for the role of Director, CMC Program Management in CMC Product Strategy (CPS) organization to work in the exciting space of cancer cell therapy. This individual will be a part of CPS Senior Leadership Team (CPS SLT), responsible for the CMC project management team and will work closely with the CMC Teams (CMCT) and Technical Operations (Tech Ops) functions to support the development of CMC strategy, to provide project management for CMC portfolio, products and projects, and to facilitate effective planning and communication.

The mission of CMC Product Strategy organization is to develop competitive CMC product strategy that maximizes patient-centric product values. The Head of CMC Portfolio and Program Management plays a critical role in driving productivity of the CMC teams. The director will lead the CMC project managers to provide consistent and best practice project management for CMC portfolio management and communication, and support for the CMC teams, including developing strategy and goals documents, program timelines, gate reviews and other governance presentations, risk registry, cost forecast, and program status reporting/communication, facilitating scenario/option analysis, following up with action items and supporting issue resolution.

In addition, the head of CMC PPM will support CPS Senior Leadership Team in continuous improvements and change management of CMC Team operating model, governance and roadmap. The head of CMC PPM will also work closely with Kite Global Portfolio and Program Strategy (GPPS) team to align on Cell Therapy Operating Model (CTOM) and business processes.

 

Responsibilities (include but limited to):

Managerial Responsibilities:

• Lead the team of CMC project managers to support CMC product development for Kite pipeline, commercial products, and cross-product projects.

• Develop and coach individuals and team performance and provide guidance and priorities from both product development and project management perspectives.

• Drive and optimize CMC portfolio management processes, including portfolio reviews, progress/dashboard reports for product-specific and cross-product initiatives, goals setting, site visits planning, and gate review planning.

• Develop and standardize project management process and tools to be utilized consistently for all CMC Teams. Develop and implement best-in-class PM processes and tools/templates and harmonize PM practices across projects/programs/sites.

• Support CPS Senior Leadership Team (CPS SLT) in cross-functional alignment and communication, continuous improvements and change management of CMC Team operating model, governance and roadmap.

• Support and monitor the implementation and execution of CMC governance process and operating model processes.

• Partner closely with Kite Global Portfolio and Program Strategy (GPPS) team to align on Cell Therapy Operating Model (CTOM) and business processes.

• Exemplify enterprise mindset and focus on innovation and operational excellence

 

CMC Team Project Management Responsibilities:

• Provide project management expertise for the cross-functional CMC Teams, including developing goals, aligning on priorities, generating options and recommendations, facilitating meeting/workshops/collaboration, creating project plans and timelines, and defining/reporting metrics.

• In collaboration with the CMC Team Lead (CTL), drive and lead CMC strategy development for product-facing CMC Teams in alignment with Product Team (PT) goals.

• Lead the development and management of integrated cross-functional CMC Team product development strategies/plans, risk registers, dashboards, and other ongoing and ad hoc project management reports.

• Lead CMC program risk management, proactively identifying risks, developing strategies and plans to address them appropriately, track progress and drive the teams to successfully overcome issues and challenges.

• Lead development of product presentations for CMC stage-gate reviews for senior leadership; drive and support teams through these reviews, holding teams accountable for endorsements and agreed upon goals.

• Partner with and advise senior management and governance bodies within Process Development and Technical Operations to ensure transparent and informed decision making, adhering to the governance process.

• Other duties as assigned.

• Occasional travel may be required.

 

Requirements:

• Bachelor's degree in sciences or related field with 12+ years of pharmaceutical or biotech industry experience in program management, OR

• MS/MBA in sciences or related field with 10+ years of pharmaceutical or biotech industry experience in program management OR

• Ph.D. in sciences or related field with 8+ years of pharmaceutical or biotech industry experience in program management

 

Preferred Requirements:

• A PhD or MBA is highly preferred.

• Cell therapy experience is highly preferred.

• Strong understanding of drug development and interdependencies

• 2-4 years of people management experience with strong leadership and organizational skills to coach team members' performance, build a strong team and support career development.

• Knowledgeable in cGMP manufacturing and CMC regulatory requirements for pharmaceuticals and devices; cell therapy CMC experience is strongly preferred.

• Able to express ideas and present information effectively within teams, functions, and with external partners.

• Able to think critically and demonstrate troubleshooting and problem-solving skills.

• Demonstrate active listening and constructive feedback within team, ability to facilitate problem solving, decision making, and issue resolution.

• Demonstrated analytical and technology skills, including proficiency in project planning tools, content management tools, and the Microsoft Office Suite

• Strong program management skills. Project Management certification or equivalent is a plus.

• Excellent interpersonal, verbal, and written communication skills are essential in this matrix environment.

• Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities.

 

#LI-ML1

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 http://www.kitepharma.com. Sign up to follow on Twitter at http://www.twitter.com/kitepharma.

 

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