Seagen

Clinical Trial Transparency Specialist

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:

This position reports to a senior professional within the Clinical Trial Transparency & Disclosure (CTTD) team and executes against the global cross-project disclosure plan. Key responsibilities include maintaining an understanding of regulatory requirements to manage timely, accurate, consistent, and responsible disclosure of global clinical trial information.

Principal Responsibilities:

• Responsible for preparing routine clinical trial disclosure submissions to ensure compliance with defined timelines on public database registries
• Represents CTTD on clinical study teams for the initial registration and maintenance of applicable clinical trials on public database registries, including results reporting when appropriate
• May assist in disclosure of lay summaries and identification of personal private and company confidential information for health authority transparency submissions (e.g., EMA Policy 0070)
• Contributes to cross-functional operational activities supporting data requests from qualified researchers
• May perform research and assessments to inform global cross-project disclosure plan
• Contributes to process improvement by refining work instructions, training materials, and procedures as needed
• Stays informed of evolving policies and best practices in the area of clinical trial disclosure and transparency

Required Qualifications:

• Bachelor’s degree
• 2-3 years of experience in project management or related field
• Excellent written and verbal communication skills
• Strong organizational skills; able to manage conflicting priorities and adhere to tight timelines
• Proven ability to work with a high level of integrity, accuracy, and attention to detail

Preferred Qualifications:

• 1 year in pharmaceutical or trial disclosure industry experience preferred
• General knowledge of the US drug development process and regulatory requirements desirable
• Experience with Adobe Acrobat, Smartsheet, Clinical Trial Management Systems, and SharePoint 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.

The hiring pay range for this position is $88,000 - $114,000 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: 01/20/2023