Seagen

Nonclinical Outsourced Study Supervisor

Description

Summary

We are seeking an individual to join a team of experienced toxicologists and pathologists to supervise contracted nonclinical studies. In partnership with the lead scientist, the individual will be the point of contact and sponsor representative for externally contracted non-GLP and GLP nonclinical toxicology studies. The successful candidate will perform duties of a nonclinical outsourced study manager, including but not limited to: logistical elements of study conduct including study scheduling, protocol development in collaboration with functional representatives, comprehensive CRO oversight (including managing contracts/change order requests, protocol amendments), reviewing reports and study related communications for content and accuracy; coordination of test article shipment; and document archiving. This role will contribute to the completion and reporting of on-time high quality data and will assist with data analysis/graphical representations on studies with rapid turnaround time. The individual will need to communicate effectively across multiple functional areas and programs, be proactive and timely, must have a strong understanding of science, GLP regulations, and preclinical CRO landscape.

Principal Responsibilities:

• Serve as a Study Monitor and coordinator for nonclinical outsourced studies, and facilitate planning, protocol development, and timeline generation for outsourced studies
• Compile data (figures and tables) and slide preparation for internal discussions and/or presentations as well as compiling and QC of nonclinical data tables
• Demonstrate clear and concise verbal and written communication and facilitate open communication between internal and Contract Research Organization (CRO) scientists.
• Manage contracts, invoices, and purchase requisitions for each nonclinical project.
• Coordinate test article supply and tracking stability testing to support each toxicology study.
• Edit, review, and QC reports and nonclinical sections of regulatory submissions.
• Provide support during regulatory inspections and internal functional group audits.
• Contribute to SOP development and process improvement initiatives

Qualifications:

• Bachelor’s degree or Master’s degree in scientific or quality-related field and at least 5 years of experience in toxicology, pharmacology, pharmacokinetics, immunology, biological sciences, or related discipline
• Previous GLP experience in pharmaceutical or biotechnology industry or equivalent GXP transferable experience
• Solid understanding of drug development, study design, data management systems, procedures, and documentation practices
• Demonstrated ability to successfully manage multiple studies ongoing at the same time.
• Effective communicator both verbally and in writing
• Must be detail oriented, with ability to multi-task and work in both an individual and team-based environment
• Excellent interpersonal, organizational, and problem-solving skills required.
• Ability to influence and negotiate effective solutions
• Proficient with MS Office and Adobe Acrobat in PC. Good understanding of other computer systems a plus

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: 03/12/2021