Seagen

Principal Lab Data Specialist (Remote)

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 Principal Lab Data Specialist (Pr. LDS) is a management-level LDS responsible for independent oversight of all clinical specimens and associated laboratory data collected on clinical trials, including safety labs, PK, biomarkers, tumor samples, etc. The Pr. LDS functions independently in program lead capacity, providing input and insight on high-level operational plans related to clinical specimens and ensuring that product and study deliverables are completed on time, with a high degree of quality. On a clinical study team, they oversee complex lab-related aspects of trials by collaborating with cross-functional teams to plan, develop and execute operational objectives without oversight. Additionally, they play an integral role in laboratory vendor evaluations and startup, development and review of study protocols and scientific oversight of analytical laboratories. The Pr. LDS has an in-depth understanding of clinical laboratory and biomarker testing typical in an oncology setting and is adept at handling specimens and lab data. They have applied knowledge of FDA regulations, clinical data management best practices, and general industry standards and will lead departmental infrastructure development.

Principal Responsibilities:

• Independently manage and operationalize clinical specimen and data management procedures, including authoring data transfer plans, data review plans and overseeing the transfer, processing, and storage of data. Ensure standardization is maintained and develop new standards and practices where needed
• Independently drive multiple project streams, each with their own timelines, objectives and deliverables, including pivotal, blinded and randomized trials Function as sole independent unblinded LDS for randomized studies and outline processes for data flow to ensure study team blind is maintained
• Lead data cleaning activities for vendor data reconciliation. Gather cross-functional input to drive creation of custom data review plans. Evaluate options and exercise critical thinking to choose efficient and effective issues resolution paths
• Work with internal and external stakeholders and LDS team to ensure specimen testing is conducted efficiently to in accordance with study plans and timelines
• Ensure integrated tracking and inventory log of all specimens collected during a clinical trial, interpret data, and create KPIs and metrics to share with stakeholders
• Represent Data Management in governance bodies, product teams and cross-functional groups. Foster collaboration and relationship-building across departments and teams
• Manage vendor relationships and oversee vendor collaborations to efficiently drive projects forward, overcome challenges, establish best practices, and ensure quality data
• 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
• Research, evaluate, and direct departmental initiatives and new technologies/innovations to improve processes and infrastructure
• Align with and support management and corporate objectives
• Create detailed specifications for tabular and unstructured data by working with various stakeholders to ensure appropriate metadata variables and fit-for-purpose data structure that meet end user needs
• Provide expert feedback on contracts and study documents to ensure alignment with stakeholders’ needs, internal processes, and vendor capabilities. Facilitate discussions and gain alignment as needed
• Adeptly run SAS programs, review SAS logs, and generate output. Program SAS Non-System Edit Checks (NSECs) and/or SAS Data Listings as appropriate for SAS skill level. Mentor less proficient SAS users and initiate process improvements
• Lead training and mentoring of Biomarker Data Specialists I/II and/or contract staff; utilize experience and leadership skills to provide guidance to other team members

Qualifications:

• Minimum of 5 years of relevant experience
• Demonstrated leadership, project management, risk assessment, decision-making and timeline management skills
• Experience working on clinical research projects in the biotechnology or clinical drug development field
• Clinical testing lab and/or vendor oversight experience
• Laboratory background and strong knowledge of commonly tested biomarkers in the oncology setting, latest and advanced analytical tools, and assays
• Prior experience authoring specifications and implementing new processes
• Proficiency with data sets and Excel, strong understanding of data relationships and metadata
• 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 without oversight
• Excellent written/verbal communication skills
• Interpersonal skills; facilitates collaboration, is a team player and is cooperative, builds constructive and effective relationships, is approachable, communicates effectively
• Flexible, easily adapts to change, and is energized by challenges and problem solving • Demonstrated ability to learn new skills and knowledge quickly, able to offer new ideas but also willing to adapt style to existing process as appropriate
• Understanding of FDA regulations, ICH GCP guidelines, SDTM, CDISC, database development, and UAT Preferred:
• Software programming or systems development experience
• Previous LIMS (Laboratory Information Management System) experience
• Previous Electronic Data Capture (EDC) experience
• Prior experience managing vendors/CROs
• Oncology experience

Education:

• 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.

The hiring pay range for this position is $119,000 to $154,000 per year based on skills, education and experience relevant to the role. Other components of total compensation include a competitive equity grant at the time of hire (with additional annual grants, and grants upon promotion when applicable), and an annual bonus.

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: 03/10/2023