| Description |
The position reports to the Senior Medical Director, Clinical Affairs, and will play a critical role in setting the clinical development strategy for one or more of the products in our growing pipeline. The successful candidate will function as a scientific and medical resource for the clinical affairs department at Seattle Genetics, and as medical monitor for ongoing clinical trials in oncology.
This is a great opportunity to join a growing team and make a difference in the lives of cancer patients using our proprietary ADC technology.
Duties will include:
For one or more development molecules:
- Represent Clinical Affairs on appropriate core and subteams
- Define and refine the clinical development strategy to support the target product profile and product development plan for both US and ex-US registrational filings
- Contribute to the development of clinical protocols and amendments, investigator brochures, and clinical study reports for current and future studies
- Assure appropriate medical monitoring for clinical studies
- Evaluate safety, pharmacology, and efficacy data from ongoing and completed studies
- Prepare manuscripts, abstracts and presentations for scientific meetings
- Literature and competitive intelligence review of therapeutic area space
Serve on or attend oversight bodies, including Development Review Committee, Clinical Protocol Committee, and Medical Management meeting
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| Required Skills |
REQUIREMENTS: This position requires an MD, PharmD, or PA degree with significant clinical experience in oncology. Board certification in a relevant discipline a plus. A minimum of 3-5 years industry experience focused on the clinical evaluation of bio/pharmaceuticals for the treatment of malignancy is required. Demonstrated expertise in the conduct of pre-licensure clinical trials, GCP compliance, and drug development is mandatory. Experience in FDA and European regulatory interactions a plus. Outstanding communication skills, independent thinking, and the ability to lead in a team environment are essential.
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