Associate Director/Director Global Technical Development Leader
In this capacity the incumbent will provide strategic leadership to one or more CMC programs teams and is accountable for all late stage development activities, for small molecules, drug linkers and biologics. They are accountable 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 well characterized, robust, analytical methods and manufacturing processes to the Commercial Product Supply organization. As a member of the Strategy & PMO leadership team and in the spirit of learning and continuous improvement they need to advance functional and organizational excellence.
- Lead cross-functional CMC Team(s) to develop, adapt and drive an integrated CMC development strategy for late stage programs, taking into account, corporate priorities and objectives.
- Represent TOPS and CMC Team on Global Product Team, and jointly establish strategy and tactics for development and commercialization of innovative drugs
- Serve as the primary CMC 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 CMC functions, including Process Sciences, Analytical Development, Manufacturing, 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 CMC 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 CMC 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 CMC Strategy & Management leadership team
- Director Level – 10+ years of biopharmaceutical drug development experience and 5+ years direct or indirect team management/leadership (i.e., direct reports or matrixed team leadership)
- Associate Director Level – 5-10+ years of biopharmaceutical drug development experience and 2-5+ years direct or indirect team management/leadership (i.e., direct reports or matrixed team leadership)
- Ability to effectively handle ambiguity and uncertainty
- Proven ability to build trustful and effective relationships
- Able to think strategically and translate strategies into actionable plans
- Strong verbal and written communication skills and the ability to influence at all levels
- Master’s or Doctorate degree in a scientific, or engineering discipline
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 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.