ADCETRIS Global Development Lead, Vice President, Clinical Development
The ADCETRIS Global Development Leader (GDL) leads the development of ADCETRIS and other CD30 directed therapies. He/she has overall accountability for the program. The GDL is also responsible for defining and delivering a comprehensive development strategy, and will partner with Commercial, TOPS and Program and Portfolio Management to ensure effective and efficient execution of the program. The GDL leads the Global Development Team (GDT) and represents Development on the GPT. The GDL is also accountable for all Development decisions made at the Global Product Team (GPT). For partnered programs the GDL is responsible for working closely with partners to align and execute on a joint development strategy. The GDL is the primary representative of the product at governance meetings.
The GDL serves as a scientific and medical expert both internally and externally and represents the product strategy, plans, objectives, and interests to health authorities (HAs) and prominent thought leaders worldwide.
- Overall strategic lead and is accountable for delivering on the program strategy. Represent the Development strategy at the Global Product Team to develop and execute an integrated cross-functional global product strategy working in partnership with GPT members (Regulatory, Safety, Medical Affairs, CMC, Value & Access, Commercial and Program Team Leadership & Management) and key contributors (Biostatistics, Translational Sciences)
- Lead the Global Development team accountable for developing and executing the development strategy of a late stage program. The GDL will design and guide strategy from proof of concept through initial approval and subsequent development
- Direct line management of multiple medical directors. Oversight of other staff in the matrix environment
- Accountable for the design, execution and medical/scientific data interpretation of global clinical studies. Provides advice and guidance on other evidence generation programs
- Oversee the diagnostic and biomarker plans for the program
- Oversee the clinical pharmacology plans to support registration
- Provide clinical leadership for global regulatory submissions
- Oversee and is accountable for the evaluation and interpretation of safety, pharmacology, and efficacy data from ongoing and completed studies
- Oversee strategy and execution of preparation of manuscripts, abstracts and presentations for scientific meetings and Development advisory boards
- Collaborate with a variety of internal and external partners and stakeholders, such as HAs, clinical investigators, clinicians, scientists and key opinion leaders (KOLs)
- Provide leadership and management to clinical personnel and medical monitors who support the clinical study teams
- Medical resource for design and interpretation of clinical and preclinical programs to support existing and new development candidates
- Demonstrated experience working on late stage product development, including global regulatory filings. Experience with product launches and life cycle management is preferred
- Demonstrates strategic agility: has in-depth knowledge and broad experience in the pharma/biotech industry and is able to bring this to bear in accomplishing strategic goals and objectives
- Has a strong leadership presence and the ability to work effectively with other clinical/scientific and cross functional leaders
- Demonstrated expertise in study design, protocol generation and data analysis
- Outstanding interpersonal skills; proven track record of building strong and sustainable relationships with internal & external partners/stakeholders
- Strong staff management and mentoring experience and skills
- Strong verbal and written communication & presentation skills; exhibits professional maturity, confidence and competence. Knows how to summarize, represent and communicate the key points for others to effectively and expeditiously make important business decisions
- Is a team player, works well in a team environment both as a leader and a key contributor
- Has a global perspective and mindset, with the ability to work effectively with colleagues from varied cultures, backgrounds and geographies
- Able to work remotely and with remote global teams when necessary
- M.D. or M.D./Ph.D. with board certification in oncology and/or hematology preferred
- Minimum 7 years industry experience in oncology drug development preferred
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.