Senior Director Global Technical Development

Small Molecule Development and PMO Bothell, Washington


Description

Summary:

The Head of GTD Portfolio Team is a global position within Seagen’s Technical Operations (TOPS) function, reporting to the Head of TOPS Strategy & Portfolio Management Office. This individual provides strategic leadership to the entire Global Technical Development (GTD) department consisting of GTD Leads and Project Managers. In addition, the incumbent leads multiple GTD Programs, and engages cross-functionally across Technical Operations (TOPS) as well as Seagen R&D to deliver 3 goals:

 

  1. CMC - orchestrate development activities including small molecules, drug linkers and biologics (i.e., mAB),
  2. Clinical Supply of Investigational Medicinal Product (IMP) and
  3. Technology Transfer of well-characterized, robust, analytical methods and scale appropriate manufacturing processes to the Commercial Product Supply organization.

 

The newly created position requires this individual to design and implement GTD infrastructure (methodology, best practices, tools, and other elements) in order to achieve a consistent, harmonized and scalable approach to GTD Program execution. This individual provides thought leadership to Executives and collaborates with R&D to design & implement the next generation of the Pipeline operating model. 

 

The leader is accountable for the GTD portfolio management i.e., elevate/resolve/guide cross-program topics by establishing the GTD Portfolio governance practices.  The leader will provide umbrella view across all GTD programs via aggregation of data/reports/risks/etc. and enable visibility throughout the organization.

 

The leader demonstrates commitment to Seagen’s mission and role models corporate values & behaviors.

 

Responsibilities:

  • Provide strategic thought leadership to TOPS executives, combining both scientific/technical knowledge as well as business drivers.
  • Lead ~8-10 direct reports of GTD Leads/PMs and influence functional SMEs via matrixed set up.
  • Lead cross-functional GTD/CMC Team(s) to develop, adapt and drive an integrated GTD development strategy for approved programs, considering, corporate priorities and objectives.
  • Represent TOPS and GTD Team on Global Product Team (GPT), and jointly establish strategy and tactics for development and commercialization of innovative drugs.
  • Serve as the primary GTD point of contact and product representative on executive management and governance committees.
  • Establish GTD Methodology and Portfolio-level governance and life-cycle risk management.
  • Work closely across all key TOPS functions to influence, advise, and coordinate strategic and operational efforts, including Process Sciences, Analytical Development, Manufacturing, Quality and CMC-Regulatory to ensure strategic alignment and seamless execution.
  • Work closely with alliance partners, on co-development programs, to develop and execute a joint global GTD strategy which delivers on the shared vision for the product while successfully delivering company-specific expectations.
  • Drive team objective setting, prioritization and ensure adherence to plan and strategy.
  • Drive risk management, issue identification, resolution, and contingency planning.
  • Identify opportunities for improvement, product lifecycle support, and lead development of action plans.
  • Create a positive team environment which instils trust, encourages disconfirming information, and enables clear transparent communications, to facilitate alignment around the overall goal/vision for the product.
  • Accountable to Global Product Team
  • Accountable to Technical Operations management and governance bodies
  • On partnered programs, accountable to joint governance committees with GTD oversight responsibility
  • Stay abreast of changes in the regulatory standards and expectations, evolving business needs, and scientific advancements to determine impacts on the product’s CMC package and the need for adjustments.
  • Advance functional and organizational excellence as a member of the Strategy & Management leadership team

 

Qualifications:

  • 15+ years of biopharmaceutical drug development experience, with at least 5 years of development program/portfolio management experience that includes CMC, IMP supply, and Tech Transfer.
  • Experience with establish project methodologies, governance, and risk management.
  • 10+ years direct or matrixed team management/leadership
  • Understanding of and experience with cGMP and GCP fundamentals
  • Experience with scenario planning, financial modeling, and risk management
  • Experience with use of technology/digital tools/enablers
  • Demonstrated proficiency in managing portfolio of development projects and in leading change.
  • Track record of success in the rigorous planning, execution and timely delivery of enterprise level development projects and programs
  • Proven innovation & opportunity identification translated to tangible initiatives and successful value capture.
  • Builds relationships, able to negotiate & influence, and manage change in a global matrix environment.
  • Exceptional skills in leadership, coaching, analytical problem solving and strong business acumen.
  • Superior written and verbal executive communication, presentation, and interpersonal skills such as influence, persuasion
  • Up to ~30% travel (domestic and International)

 

Education:

  • Advanced Degree in a Scientific / Engineering discipline
  • MBA is preferred.
  • PMI PMP Certification is a plus

  

As the leading employer in our industry in the Pacific Northwest, Seagen 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 Seagen, please visit www.seagen.com. 

Seagen 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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