Seattle Genetics

Senior Manager EDC Systems

Description

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.

Summary

The Sr. Manager, EDC Systems will oversee EDC Programmers (EDCP) within Clinical Data Management and will ensure that product and study level deliverables are completed on time, with a high degree of quality, and in accordance with corporate and regulatory requirements. This position will also be responsible for managing salaried and contract EDCPs./p>

Responsibilities:

• Manage EDCPs efficiently across studies by setting goals and providing oversight, guidance, mentoring, feedback and performance reviews. Perform hiring and training activities as needed.
• Manage/coordinate work performed by EDC vendors and CROs as appropriate to ensure quality of product. Assist in the selection of vendors/CROs (e.g. review RFPs, attend site audits).
• Develop and guide team members through the development of DM documents including program specifications.
• Research, evaluate, and direct departmental initiatives and new technologies/innovations to improve CDM processes; represent EDC Systems through working groups (internal and external) and initiatives where thorough knowledge of EDC Systems practices/processes are required.
• Align with and support management and corporate objectives.
• Support of implementation of data standards.
• Perform study resourcing and budget support as appropriate.
• Drive and guide complex process and initiatives.
• Communicate and message information to multiple levels of leadership appropriately; applying appropriate level of detail to audience to ensure efficient utilization of resource.
• Encourage collaboration through relationship building with other leaders; ability to influence without authority.

Qualifications:

• Minimum of 10 years of relevant experience.
• Requires effective organizational and communication skills.
• Technologically savvy; quickly picks-up on new information, standards, regulations, tools, methods or software as it relates to position and profession.
• Detail oriented; performs quality and accurate work.
• Thorough knowledge of FDA regulations, ICH GCP guidelines, SDTM, CDISC, database development, UAT, medical coding, the drug development process.
• Previous programming languages experience.
• Strong experience and knowledge in the application of data standards.
• Excellent supervisory, problem solving, negotiation and organizational skills.
• Knowledge and understanding of DM Lifecycle associated with P1-P3 studies, including pivotal, blinded, and randomized trials.
• Exhibits composure and strong conflict management skills.
• Prior experience managing vendors/CROs.
• Preferred:
• Previous experience with RTSM/IWRS and ePRO systems.
• Previous experience working on oncology trials.
• Previous management experience.

Education:

• BA/BS in relevant field strongly 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.

Apply:

Seattle Genetics

Seattle Genetics is an Equal Opportunity Employer

Submitted: 11/23/2019