Seagen

Manager Biomarker Data Management

Description

The Manager, Biomarker Data Management will co-lead the Biomarker Data Management (BDM) Team and external lab data activities for clinical studies. They will oversee projects and processes related to clinical samples, laboratory vendors and external lab data. Functioning as a global project lead for BDM, they will ensure that product and study deliverables are completed on time, with a high degree of quality, and in accordance with corporate and regulatory standards. The Manager, BDM has expert knowledge of FDA regulations and general industry standards and supports departmental infrastructure development. This position will also be responsible for managing salaried and contract Biomarker Data Specialists.

Principal Responsibilities:

• Supervise Biomarker Data Specialists efficiently across studies and projects by setting goals and providing oversight, guidance, mentoring, feedback and performance reviews. Perform hiring and training activities as needed
• Lead/co-lead BDM team to ensure peak performance, continuous improvement, cross-functional collaboration, knowledge-sharing and accountability. Activities include: leading meetings, supporting cross-departmental initiatives, creating/updating procedures, facilitating alignment, implementing governance, creating metrics and presenting to leadership bodies.
• Manage and coordinate work performed by vendors/CROs to ensure quality product and timelines, objectives and deliverables are met
• Oversee laboratory data management procedures and specification documents to ensure standardization is maintained; develop new standards and practices where needed
• Independently perform and guide team members through lab specimen and data management processes for clinical trials from study start-up to database lock in an efficient and timely manner. Activities include, but are not limited to, specimen management plans, vendor scopes of work, data transfer plans, data review plans, data reconciliation and cleaning, study timeline and deliverable management, stakeholder management, vendor management
• Oversee specimen management across all studies, driven by appropriate metrics for performance and quality and ensure adherence to timelines
• Ensure consistency across programs and protocols for comprehensive strategy
• Engage in negotiation and management of competing priorities across multiple functional areas
• Proactively escalate and creatively resolve issues; apply knowledge of industry, best practices and risk assessment to assist in mitigation
• Lead and guide team on non-CRF data expectations, data reconciliation and cleaning activities on clinical studies, including on pivotal, blinded, and randomized trials
• Represent Data Management in governance bodies, product teams and cross-functional groups; lead internal working groups
• Research, evaluate, and direct departmental initiatives and new technologies/innovations to improve processes and infrastructure
• Align with and support management and corporate objectives

Qualifications:

• Years of experience: 8+ years professional experience in clinical research and/or relevant laboratory work
• Experience working on clinical research projects in the biotechnology or clinical drug development field
• Laboratory background and strong knowledge of: specimen management, commonly tested biomarkers in the oncology setting, latest and advanced analytical tools and assays
• Skilled in project management, leadership and time management; able to prioritize successfully
• Able to perform multiple tasks simultaneously under limited direction and on own initiative
• Prior experience writing specification documents and/or work instructions
• Confident in overseeing 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 work with minimal oversight
• Excellent written/verbal communication skills
• Can identify opportunities for efficiency improvements and simplification, recognizes appropriate resources for deliverables, has effective organizational skills
• Interpersonal skills; encourages collaboration, is a team player and is cooperative, builds constructive and effective relationships, manages conflict, is approachable, communicates effectively
• Flexible, easily adapts to change, and is energized by challenges and problem-solving
• Previous Electronic Data Capture (EDC) experience
• Strong knowledge of FDA regulations, ICH GCP guidelines, SDTM, CDISC, database development, and UAT

Preferred:

• Previous supervisory experience
• Software programming or systems development experience
• Previous experience working on oncology trials
• Prior experience managing vendors/CROs

Education

• BA/BS 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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Seagen

Seagen is an Equal Opportunity Employer

Submitted: 01/08/2021