Associate Director Biomarker Data Management

Clinical Development Operations US Field Based


Description

Summary: 

The Associate Director, Biomarker Data Management (BDM) will direct BDM team activities and 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 be responsible for managing salaried and contract personnel within the Biomarker Data Management team. 

 Principal Responsibilities: 

  • Manage Biomarker Data Management team efficiently across studies by setting goals and providing oversight, guidance, mentoring, feedback and performance reviews  
  • Lead and oversee hiring and training activities as needed 
  • Manage work performed by vendors/CROs to ensure quality product and timelines, objectives and deliverables are met 
  • Oversee laboratory data management procedures and specification documents and ensure standardization is maintained 
  • Guide team members through lab data management processes and specification documentation for clinical trials from study start-up to database lock in an efficient and timely manner 
  • Guide team on non-CRF data expectation, data reconciliation and cleaning activities on clinical studies, including on pivotal, blinded, and randomized trials 2 
  • Develop and guide team members through the implementation of SOPs, templates and processes and other departmental and/or cross functional projects 
  • Drive and guide complex departmental initiatives and new technologies/innovations to improve processes and infrastructure 
  • Align with and support management and corporate objectives 
  • Communicate and message information to multiple levels of leadership appropriately; applying appropriate level of detail to audience to ensure efficient utilization of resource 
  • Lead collaborations through relationship building with other leaders 

Qualifications: 

  • Years of experience: 10+ years and 5+ years of management experience and/or demonstrated success managing and leading teams 
  • Extensive experience working on clinical research projects; proficient understanding of the clinical drug development field. Knowledge and understanding of DM Lifecycle associated with P1-P3 studies, including pivotal, blinded, and randomized trials 
  • Laboratory background and strong knowledge of commonly tested biomarkers in the oncology setting, latest and advanced analytical tools and assays 
  • Strong project management, leadership and time management skills; able to prioritize successfully 
  • Prior experience managing vendors and communicating with experts to drive quality deliverables 
  • 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 
  • Excellent written/verbal communication skills 
  • Exhibits composure and strong conflict management skills 
  • Excellent supervisory, problem solving, negotiation and organizational skills 
  • Strong team building and resource allocation experience 
  • Ability to identify opportunities for efficiency improvements and simplification and recognizes appropriate resources for deliverables 
  • Knowledge and understanding of CRF database build and data flow 
  • Previous relevant Electronic Data Capture (EDC) experience 
  • Working knowledge of FDA regulations, ICH GCP guidelines, SDTM, CDISC, database development, and UAT 
  • Working knowledge of software programming or systems development experience 

Education: 

  • BA/BS or higher in relevant field

As the leading employer in our industry in the Pacific Northwest, Seagen 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 Seagen, please visit www.seagen.com. 

Seagen 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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