Director Compliance Business Partner R&D
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!
We are currently seeking a Corporate Compliance professional with pharmaceutical/biotech industry experience. The position will report to the North American Compliance Officer (CO). This position manages compliance risks related to the Research and Development and Medical Departments, with significant interaction with the R&D team, Clinical Trials Organization, Medical Affairs Team, HEOR and other company departments. The Director of Compliance works to continuously enhance Seagen's Compliance program based on the legal enforcement environment through application of best practices in the life sciences Compliance space
- Provide strategic direction for the US Compliance function across all OIG seven elements of an effective compliance program leveraging knowledge of industry best practices
- Partner with and advise business stakeholders to prepare an annual compliance work plan based upon a comprehensive, annual compliance risk assessment
- Proactively plan for emerging trends in compliance, anticipate the impact on processes, and work with business stakeholders to determine how to address them using the most up to date information around emerging state and federal laws, U.S. government enforcement actions, evaluation of Corporate Integrity Agreements, etc.
- Advise and provide support to business functions to maintain an internal infrastructure that supports a culture of compliance and recognizes that compliance is a collective responsibility of all employees
- Establish strong relationships with key internal stakeholders to understand current and future compliance needs
- Maintain a current working knowledge of various laws, regulations, and industry guidance that affect the corporate-wide compliance program, including federal and state government price reporting laws, state and federal privacy laws including GDPR, OIG and DOJ guidelines, PhRMA code and state marketing compliance laws
- Provide guidance to the Business and integrate compliance controls into the scope of existing business practices where applicable
- Partner with corporate compliance investigations regarding potential violations of compliance policies, laws or regulations and oversee corrective actions with business functions
- Work with internal Compliance Audit to develop annual audit plans for the business and work with the business to timely complete corrective action plans
- Work with internal Compliance Risk Assessment to complete implementation of Seagen’s Risk Assessment process and assist business with ongoing updates of the Risk
- 7-10 years of recent, relevant in-house experience in a pharmaceutical or biotechnology company’s compliance department is required
- Knowledge of and experience with US laws, regulations, and industry guidance that affect the pharmaceutical industry
- Effective public speaking skills and an ability to communicate in both verbal and written form with multiple stakeholders within and outside the company
- Ability to lead and work effectively with cross-functional teams and projects
- Strategic leadership capability, strong organizational awareness, sound judgment, strong business acumen and ability to make decisions with input from multiple stakeholders
- Strong problem solving and risk analysis skills
- Sound judgment and commitment to ethical conduct
- Ability to effectively prioritize and work in a fast-paced environment and to handle multiple complex and confidential tasks
- Travel as necessary
- Bachelor's degree required
- JD or other advanced degree preferred
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.