Seattle Genetics
Manager, Medical Affairs EU
Medical Affairs - Zug, Switzerland
Description
Seattle Genetics Seattle Genetics is an emerging multi-product, global biotechnology company that develops and commercializes transformative therapies targeting cancer to make a meaningful difference in people’s lives. ADCETRIS® (brentuximab vedotin) uses 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 use 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. More information about Seattle Genetics can be found at www.seattlegenetics.com.
Summary
The Manager, Medical Affairs (MA) EU role supports the Medical Affairs Europe HQ core- capabilities buildup such as insight generation, medical communication, medical education and reports into the Associate Director, Medical Affairs EU. This role contributes to the establishment and maintenance of the SOP framework for Medical Affairs operations in Europe. In addition, it fulfills the position as Medical Information professional for the Medial Affairs EU HQ and will support the further build up and maintenance of the MI EU network. In accordance with the appropriate framework in place this role supports the internal medical material review process and conducts the internal trainings set up for Medical Affairs EU HQ and the EU Affiliates. If required, in the scope of the Medical Manager EU role is as well data- generation oversight and additional responsibilities such as EAP and IST management support.
Responsibilities:
- Act as Coordinator for internal medical material reviews and act as Coordinator for the approval of other materials, as needs may be.
- Internal Medical Training coordinator responsible to MA EU and EU Affiliates.
- Support MA EU congress overview and activities.
- Support MA EU Medical Information.
- Provide verbal and written clinical and technical responses to external experts.
- Create, revise, update and review regional standard response documents.
- Utilize appropriate resources to respond to unsolicited medical information inquiries and requests in a fair, balanced and scientific manner, verbally and in written form.
- Staff the medical affairs booth at major scientific meetings, if needed.
- Act as Medical Information Subject Matter Expert for EU vendor for Medical Information Contact Center, for request escalations, technical/operational support, general questions, customer service issues.
- Act as Medical Information point of contact for a Seattle Genetics product, serving on product-specific committees, working groups, and sub teams when remote participation is feasible and appropriate.
- Link with the global MI leads to align on processes and procedures.
- Support the development and the provision of SOPs and guidelines to the EU MA teams in close collaboration with the global organization and regional Compliance.
- Oversee SOP writing and further development in accordance with organizational needs.
- Provide proactive recommendations when process or policy updates are needed.
- Data Generation and support to clinical initiatives.
- Responsible for coordinating annual strategy review and review of external applications for ISTs and TRAs for relevant product(s).
- Coordinates and manages relevant EAP in collaboration with respective medical director.
- Serves as cross-functional Subject Matter Expert for collaborations relevant for assigned product(s).
- Works with colleagues internally to maintain ongoing data integrity for program reporting.
- Works independently to execute projects in alignment with strategy and budget.
Qualifications:
- The successful candidate will demonstrate the following skills and experiences:
- A clinical or advanced doctoral degree (MD, PhD or PharmD) is required.
- A minimum of 5+ years’ in pharmaceutical experience is preferred, particularly in the field of hematology/oncology.
- A demonstrated ability to work cross-functionally.
- Excellent verbal and written communication skills.
- Up to 20% international traveling may be required.
- Fluent in English and additional EU languages are a plus.
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.
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Seattle Genetics
Seattle Genetics is an Equal Opportunity Employer
Submitted: 11/23/2019
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