Head of CMC Strategy & PMO

Summary:

This global position is accountable for two business critical activities within Technical Operations and Process Sciences:

• Development Stage CMC Team Leads: In this capacity the incumbent will provide strategy and leadership to development CMC program team leads and their teams with an end-to-end perspective from IND to first product launch for both small molecules, drug linkers and biologics. Responsible for defining best practices and guiding CMC team leadership for timely delivery of investigational product for first in human, on-going clinical trials and transfer of well characterized, robust, validated manufacturing processes and analytics to the Commercial Product Supply organization. Establish, mentor and coach a SGEN product pipeline CMC team leads to ensure consistent, effective and innovative CMC business processes for delivering product in support of clinical trials, process and product characterization strategies for regulatory submissions and validation strategies for product approvals. Develop CMC team leads to be effective, contributing and impactful members of SGEN Global Product Teams representing CMC as a partner to the broader, cross functional organization including Clinical Development, Commercial, Regulatory and Research. Ensure global strategies are applied to CMC processes for SGEN pipeline product portfolio. Serve as the TOPS development stage product portfolio management and operations leader establishing standards, deliverables, metrics and innovative approaches to delivering processes, manufacturing, characterization and regulatory strategies. Must be skilled in operating within a matrix organization with excellent influential and vision skills. Must be skilled with seamless collaboration and communication in a cross-functional, multi-disciplinary manner. Must be able to establish credibility and gain trust from Quality, Process Sciences, Pharmaceutical Sciences, Manufacturing, Analytical, and Supply Planning within Technical Operations organization in addition to Clinical Development, Regulatory, Commercial and Research within Seattle Genetics.

• Project Management Office Leadership: In this capacity the incumbent will provide leadership, define strategy, and build the capabilities required, including establishment of governance forums for project prioritization and approval. Further, they will work cross-functionally and serve as the champion for excellence in project management practices and collaborate with similar organizations in other parts of the business to adopt and harmonize practices across SGEN. They will also drive the adoption of standardized tools, establish metrics and key performance indicators, help define and re-enforce ways of working and continuous improvement. The scope covers all projects within Technical Operations and Process Sciences, including but not limited to, development and post commercialization CMC, continuous improvement / value stream mapping, alliance management, capital projects and product launch. They will also partner with the Office of the Chief of Staff and all the functional heads to develop LRP and the budget for the Technical Operations and Process Sciences organizations.

Principal Responsibilities:

CMC Team Leadership

• Provide leadership to all development stage program CMC leaders who report directly to the incumbent as well as those embedded within the development functions.
• Establish clear and measurable roles and responsibilities for CMC team leads.
• Coach and measure CMC team leads’ contribution and participation as a member of the Global Product Teams
• Support the development strategy and planning for the program and coordinate tactical plans between stakeholders (e.g. Pharmaceutical Sciences; Process Sciences; Global Quality; Global Regulatory Affairs; Manufacturing and Supply Chain, Commercial, Research, etc.)
• Bridges Commercial, Global Product Team and TOPS to ensure alignment on commercial strategy including business case development, launch sequencing and distribution alternatives, LRP and strategic resource plans for assigned projects
• Define customer needs so that TOPS can develop and implement strategies to meet them
• Ensure that Technical Operations and Process Sciences engages in Launch Planning at the appropriate time and has operational alignment with strategy and life cycle management
• Accountable for uniform implementation of the standard launch method for products
• Facilitates seamless transition to commercial CMC leads
• Responsible for best practice sharing and consistent use of commonly defined methods, processes, tools, and templates

PMO Leadership

• Lead the PMO team, including establishing appropriate governance forums and development of tools, including, portfolio management, development of integrated timelines, scenario planning, prioritization, project execution, resource management, charters, business cases, dashboards, change management and project oversight
• Develop and maintain accurate resource models for the different types of projects delivered within TOPS. Allocate work across the team to leverage team strengths, build new capabilities and most importantly, ensure business critical projects and business improvement initiatives are adequately resourced and successfully executed
• Define a vision and execute a plan for ensuring project team best practices and learnings are shared across SEGNs project management community and that all teams benefit from their collective experiences
• Provides a continuously updated and balanced appraisal of the project status, including risk, cost, and value to stakeholders
• Promote a culture of collaboration, cooperation, execution excellence, effective communication and cross-functional problem-solving in an effort to building a high-performance team

Qualifications:

• 15+ years’ experience within the bio-pharmaceutical industry
• In depth knowledge of all phases of drug development and commercialization, of the functions and processes relevant to drug development and commercialization, and project management principles applicable to the biopharmaceutical environment
• Business knowledge: demonstrated knowledge of key business processes and industry awareness of trends in the bio/pharma industry with a specific focus on process sciences, manufacturing, supply chain, quality assurance, quality compliance and product launches.
• Credibility and Presence: the ability to capture the confidence of the organization in presenting new ideas or solutions
• Collaboration / Communication / Teamwork: establish and maintain successful interaction within the organization. Ability to build relationships across all levels of the organization with a high level of confidence and resiliency
• Compliance knowledge: detailed understanding of all requirements for bio/pharma system validation with responsibility to ensure systems are compliant with FDA and global regulations
• Strategic Thinking: ability to consider a problem abstractly and develop an approach that meets company strategic goals
• Leadership: ability to take independent action, working with a high-level problem or concept, developing the right next steps to propose resolution and ensuring successful outcome
• Influence Skills: ability to factually resolve conflicts and differences of opinion in a respectful yet assertive way
• Strategic Planning: Ability to package and syndicate a message, garner business support, drive and document vision / strategy, plan & organize, providing progress on multiple projects
• Outcome oriented: Balance creativity and innovation against practical / cost effective approaches

Education:

• Degree in a Scientific / Engineering/ Organizational Management field. A Higher Degree or MBA is desirable

As the leading employer in our industry in the Pacific Northwest, Seattle Genetics is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seattle Genetics, please visit http://www.seattlegenetics.com.

Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law.

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