Seagen

Director Global Technical Development Lead

Technical Operations & Process Sciences - Bothell, United States

Description

Seagen is a global, multi-product biotechnology company dedicated to developing and commercializing transformative cancer medicines. As the industry leader in antibody-drug conjugate (ADC) technology, we pioneered a new generation in the science of harnessing antibodies to deliver cell-killing agents directly to cancer cells. Seagen’s dedication to improving the lives of cancer patients goes beyond science, and we believe that every employee has a role in contributing to this mission. By working together with a shared dedication and diverse perspectives, we are able to reach our full potential and make a real difference in the world. Seagen is a fast-growing company and has an abundance of opportunities available for you to grow your career. Put your passion to work at Seagen and join us!

Summary:

In this capacity the incumbent will provide strategic leadership to one or more CMC programs teams and is accountable for all phases of (Phase I-IV) development activities. As the leader of the cross functional team, they are accountable for managing the technical development of a drug in pipeline through all phases of development, from candidate nomination to health authority submissions. This includes, design of the product, development of the processes, transfer to manufacturing sites, supporting clinical supply chain, developing commercially viable product, supporting regulatory requirements/submissions, and ultimately transferring it to commercial teams post approval. As a member of the Strategic Product Management team and in the spirit of learning and continuous improvement they need to advance functional and organizational excellence.

Responsibilities:

• Lead cross-functional Global Technical Team (GTD) to develop, adapt and drive an integrated CMC development and clinical supply strategy for all stages of programs, considering corporate priorities and objectives
• Represent Technical development on Global Product Team, and jointly establish strategy and tactics for development and commercialization of innovative drugs. Technical Development includes drug substance, drug product, technical transfer, clinical supplies and supporting functions
• Serve as the primary GTD point of contact and product representative on executive management and governance committees
• Work closely to influence, advise and coordinate strategic and operational efforts across all key Technical operations functions, including Process Sciences, Analytical Development, Manufacturing, Supply operations, Quality and CMC-Regulatory to ensure strategic alignment and seamless execution
• Work closely with 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 for developing Technical Operations strategy based on overall program and executing it per the agreed upon budget, timeline using Program Management principles
• 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 Product Management team

Qualifications:

• Director: A PhD with 15+ years of biopharmaceutical drug development experience and 5+ years direct or indirect team management/leadership (i.e., direct reports or matrixed team leadership) or A Masters with 20+ years of biopharmaceutical drug development experience and 5+ years direct or indirect team management/leadership (i.e., direct reports or matrixed team leadership) or Able to think strategically and translate strategies into actionable plans
• Proven ability to build trustful and effective relationships
• Ability to effectively handle ambiguity and uncertainty
• Strong verbal and written communication skills and the ability to influence at all levels

Education:

• Master’s or Doctorate degree in a scientific, or engineering discipline. 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.

The hiring pay range for this position is $194,000 - $250,800 per year based on skills, education and experience relevant to the role. Other components of total compensation include a competitive equity grant at the time of hire (with additional annual grants, and grants upon promotion when applicable), and an annual bonus.

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.

Apply:

Seagen

Seagen is an Equal Opportunity Employer

Submitted: 09/08/2023