Seagen

Senior Manager Lab Data Management

Development - Bothell, United States

Description

Seagen is a global, multi-product biotechnology company dedicated to developing and commercializing transformative cancer medicines. As the industry leader in antibody-drug conjugate (ADC) technology, we pioneered a new generation in the science of harnessing antibodies to deliver cell-killing agents directly to cancer cells. Seagen’s dedication to improving the lives of cancer patients goes beyond science, and we believe that every employee has a role in contributing to this mission. By working together with a shared dedication and diverse perspectives, we are able to reach our full potential and make a real difference in the world. Seagen is a fast-growing company and has an abundance of opportunities available for you to grow your career. Put your passion to work at Seagen and join us!

Summary

The Sr. Manager, Lab Data Management will lead or co-lead the Lab Data Management (LDM) Team as well as oversee complex external lab data activities for clinical studies. They will give high-level oversight to projects and processes related to clinical samples, laboratory vendors and external lab data. Functioning as a global project lead in cross-functional settings, they will ensure that their team(s) deliver product and study deliverables, with a high degree of quality, and in accordance with corporate and regulatory standards. The Sr. Manager, LDM has expert knowledge of FDA regulations and industry standards and drives departmental infrastructure development. This position will also be responsible for managing salaried and contract Lab Data Specialists.

Principal Responsibilities:

• Supervise Lab Data Specialists and Lab Data Managers expertly across various studies and projects by managing performance, coaching, setting goals and providing oversight, guidance, mentoring, feedback, and performance reviews. Attract and retain top talent.
• Support effective resourcing of the overall Clinical Data Management department by forecasting, tracking, and allocating resources; prioritize work across the LDM team.
• Independently lead/co-lead LDM team to ensure peak performance, continuous improvement, cross-functional collaboration, knowledge-sharing, and accountability.
• Activities include: designing training curricula, leading meetings, spearheading cross-departmental initiatives, creating/updating procedures, facilitating alignment and implementing governance.
• Interact with senior functional leadership to demonstrate accountability for clinical specimen and lab data management quality; present metrics, advocate for initiatives.
• Manage and coordinate complex vendor relationships to set expectations and ensure quality and consistency in work performed by vendors/CROs. Assess risks and act as a point of escalation; serve on vendor partnership and governance bodies.
• Delegate laboratory data management procedures and authorship of specification documents to ensure standardization is maintained; develop new standards and practices where needed.
• Expertly oversee training plans for junior team members to ensure their competency in lab specimen and data management processes for clinical trials from study start-up to database lock in an efficient and timely manner.
• Topics of training include: specimen management plans, vendor scopes of work, data transfer plans, data review plans, data flow and blinding, data reconciliation and cleaning, study timeline and deliverable management, stakeholder management, vendor management.
• Lead negotiation and management of competing priorities across multiple functional areas.
• Proactively escalate and creatively resolve issues; facilitate alignment and apply knowledge of industry, best practices, and risk assessment to implement fit-for-purpose solutions.
• Represent Data Management in high-visibility 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, contribute to corporate objectives.

Qualifications:

• Years of experience: 10+ years professional experience in clinical research and/or relevant laboratory work
• Previous supervisory experience
• Experience working on clinical research projects in oncology drug development
• Laboratory background and strong knowledge of: LIMS, specimen management, range of biomarkers tested in the oncology setting, latest and advanced analytical tools, and assays
• Skilled in project management, leadership, prioritization, and time management
• Able to drive multiple workstreams simultaneously under limited direction and on own initiative
• Prior experience writing specification documents and/or work instructions
• Demonstrated ability to manage vendors and communicate with experts to ensure 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: drives engagement, change management, builds constructive and effective relationships, manages conflict, communicates effectively
• Flexible, demonstrates a growth mindset, 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 Qualifications:

• Software programming or systems development experience
• Previous experience working on oncology trials
• Prior experience managing vendors/CROs
• Project Management training and/or certification

Eduction:

• BA/BS in relevant field; years of experience may substitute for education

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.

To prevent the spread of COVID-19, and as an integral part of its public health and safety measures, Seagen requires that all newly-hired employees be fully vaccinated against COVID-19 before commencing employment, subject to reasonable accommodation and other requirements of applicable federal, state, and local law.

Apply:

Seagen

Seagen is an Equal Opportunity Employer

Submitted: 09/02/2022