The Seattle Genetics Drug Safety Fellowship is a one-year, experiential program at Seattle Genetics based in Bothell, WA. The purpose of this program is to prepare PharmD fellows for career opportunities in pharmaceutical Drug Safety by providing in-depth biopharmaceutical industry experiences and enhancing clinical knowledge.
The Drug Safety Fellowship at Seattle Genetics offers an opportunity to apply one’s clinical knowledge and analytical skills while gaining a thorough understanding of pharmacovigilance across the product life cycle. Fellows will work closely with the Safety Surveillance and Epidemiology (SS&E) Lead and the Risk Management (RM) Lead in single case evaluation, aggregate data analysis, signal detection and assessments. Additionally, the fellow will the have opportunity to gain experience through strategic interactions with key cross-functional team members, such as Non-Clinical Development, Drug Safety Operations, Drug Safety Epidemiology, Clinical Development, Clinical Information Systems, Regulatory Affairs, and Medical Affairs.
The fellow will support ADCETRIS® (brentuximab vedotin), an antibody-drug conjugate (ADC) directed to the CD30 surface antigen on cells using Seattle Genetics' proprietary ADC technology. ADCETRIS® (brentuximab vedotin) is approved for the treatment of two types of lymphoma in more than 71 countries, including the U.S., Canada, Japan and members of the European Union. The fellow will also support for Seattle Genetics’ pipeline programs for multiple solid tumors.
Contribute to Pharmacovigilance and Risk Management planning for designated products
Track and evaluate potential safety issues
Perform Project Management activities for multiple studies in a program
Generate and complete a longitudinal project(s), with publication and/or presentation opportunities
Develop and deliver presentations as needed to Drug Safety and other internal groups
Support the RM lead in the development and/or execution of RMP or REMS risk mitigation activities
Conduct/support signal detection and evaluation according to standard operating procedures and guidelines
Prepare Safety Reports as necessary for safety signals or other issues (product quality)
Provide safety content review of clinical protocols, study reports, informed consent forms, and Investigator Brochures for designated products
Support the RM Lead in responding to safety requests for assigned product(s) from Regulatory Authorities, Affiliates, and other internal functions
Attend weekly SS&E meeting to relay safety concerns raised in Study Team/Clinical Sub Team Meetings
Travel may include, but is not limited to, the annual ASHP meeting
A Doctor of Pharmacy (PharmD) degree from an ACPE accredited institution
Relevant Internship or Clerkship experiences
Prior clinical or industry experience is preferred
Basic knowledge of the pharmaceutical industry including Drug Safety, Product Development, Manufacturing, Regulatory, Medical Affairs, and Commercial operations
Prior oncology experience is preferred
Completion of a PGY1 or PGY2 pharmacy residency is desirable
Evidence of appropriate analytical, planning and organizational skills
Possess good communication skills, including oral, written and presentation
Self-motivated, energetic, able to work and learn independently
Ability to thrive in a fast-paced, dynamic environment
Good medical and scientific judgement, attention to detail, and excellent interpersonal skills, including ability to work effectively cross culturally and cross functionally
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.
Application deadline is Friday, November 30th, 2018. No references necessary until final onsite interview at Seattle Genetics.
About Seattle Genetics
Seattle Genetics is an emerging multi-product, global biotechnology company and the largest based in the Pacific Northwest. We develop and commercialize transformative therapies targeting cancer to make a meaningful difference in people’s lives. ADCETRIS® (brentuximab vedotin) utilizes the company’s industry-leading antibody-drug conjugate (ADC) technology and is approved for the treatment of multiple CD30-expressing lymphomas.
Beyond ADCETRIS, the company has established a pipeline of novel targeted therapies at various stages of clinical testing, including three in ongoing or planned pivotal trials for solid tumors. Enfortumab vedotin for metastatic urothelial cancer and tisotumab vedotin for metastatic cervical cancer utilize our proprietary ADC technology. Tucatinib, a small molecule tyrosine kinase inhibitor, is in a pivotal trial for HER2-positive metastatic breast cancer. In addition, we are leveraging our expertise in empowered antibodies to build a portfolio of proprietary immuno-oncology agents in clinical trials targeting hematologic malignancies and solid tumors.
With multiple global product opportunities, significant research into advancing ADC technology and an emerging complementary immuno-oncology technology, we are positioned to transform cancer therapy.