Medical Director, Clinical Affairs - Tucatinib

Summary:

The Medical Director will oversee the direction, planning, execution and interpretation of clinical trials/research and data collection activities. The successful candidate will function as a scientific and medical resource for the Clinical Affairs department at Cascadian Therapeutics, and as a medical monitor for ongoing clinical trials in oncology.

Responsibilities:

• Assists with overall clinical development program strategy, planning and execution, including clinical trial monitoring and data collection activities, writing protocols and study reports, clinical development plans designed to enable creative and effective regulatory strategies, and safety monitoring and reporting
• Provides high level operational support and oversight to teams regarding clinical trial planning, protocol development, investigator selection, training of internal and external personnel, medical monitoring for patient safety and trial conduct, individual and aggregate clinical study event review and approval, data analysis and interpretation, quality control, and presentation/publication
• Contributes in an active and consistent manner to the scientific, clinical and commercial development of current and future product candidates (internally and externally developed)
• Establishes and approves scientific methods for design and implementation of clinical protocols, data collection systems and final reports
• May recruit clinical investigators and develop study design
• Responsible for directing human clinical trials, phases I - IV, for company products under development
• Coordinates and develops information for reports submitted to the Food and Drug Administration (FDA)
• Monitors adherence to protocols and determines study completion. May act as consultant/liaison with other corporations when working under licensing agreements
• Effectively communicates data through publications and presentations and participates in team discussions
• Maintains appropriate and accurate records of data
• Attends and participates in local, national, and international medical conferences
• Performs other responsibilities as assigned

Qualifications:

• MD degree with board eligibility or certification in oncology or hematology preferred; or equivalent
• Requires a minimum of 5 years of relevant experience with clinical trials, with pharmaceutical/biotechnology industry experience desirable
• Knowledge of Good Clinical Practices (GCP), FDA and EMEA/CHMP regulations and guidelines, and applicable international regulatory requirements
• Proven experience in medical writing is essential
• Must be effective at working in a highly collaborative environment
• Strong leadership presence who is effective at working in a highly collaborative environment, inspiring team members to contribute fully to meet team objectives
• Strong work ethic, unimpeachable ethics and honesty are critical
• Strong communication and presentation skills (one-on-one and in groups); persuasive, articulate and able to distill complex information into clear, concise concepts; straight-forward, direct and transparent communications and interpersonal approach
• Requires overnight travel (up to 30%) as necessary, consistent with project needs

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.