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!
The Associate Director, Safety Operations Delivery is accountable for the high quality and timely delivery of Seagen’s Aggregate Reports as well as PV Agreements & Training teams in Global Safety Operations. This position provides leadership and management of staff in these teams. The role also supports the Safety Compliance team with planning, preparing, conducting, and completing downstream actions related to PV audits and inspections, under the direction of Director Safety Compliance.
- The incumbent provides leadership and planning of Seagen’s Aggregate Reports deliverables in collaboration with internal cross-functional teams, external business partners, and vendors
- Leads or contributes to strategic discussions/negotiations with internal stakeholders and business partners regarding aggregate report planning, quality and collaborations
- Develops and manages execution of project plans for projects or programs, including activities, resources, budget, roles, responsibilities and quality and ensures tracking of the project or report
- Assists in the initiation, coordination and analysis of resource allocation, for report preparation
- Establishes relationships with contributing business stakeholders as well as service providers to ensure timely and quality completion and submission of reports
- Provides vendor oversight including key performance parameters
- Works on overall project planning through reporting on project schedules and deliverables
- Provides support to Global Safety Compliance function to identify risks and risk mitigation strategies
- Collaborates with key stakeholders to ensure inspection and audit readiness of GSRM staff
- Leads audit/inspection activities in close partnership with Global Safety Compliance both as SME and support role
- Serves in an advisory/consultative role in compliance related matters and supports internal team as such
- Participates in periodic quality review of data to identify opportunities for process improvement
- Directly engages with internal functions and vendors to identify root cause of any regulatory compliance risks and establishes corrective plan and execution
- Diligent follow through with any audit/inspection observations to ensure timely action and completion
- Participates in documentation of change control
- Supports Global Safety Compliance in Quality Management System (QMS) compliance activities as required by GVP regulations
- Creates and presents professional updates to senior management
- Performs other duties related to the position as required
- 8+ years of experience in Drug Safety Compliance, Quality Management and/or related area
- Ability to work independently with limited supervision and/or input into work methods
- Demonstrated ability to manage complex processes and use experience and judgment problem solving and solution development
- Excellent project management skills, general knowledge of pharmacovigilance and Aggregate Report requirements, and a successful record of managing/mentoring staff.
- Superb communication (verbal and written) skills
- Demonstrated knowledge of domestic and international regulatory safety reporting requirements
- Comparable experience in the pharmaceutical industry experience preferably in one or more of the following areas: Drug Safety, Clinical Operations, Quality Assurance or Regulatory Affairs
- Excellent organizational skills and attention to detail
- Excellent interpersonal skills, including ability to work effectively cross culturally and cross functionally
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 $184,000 to $237,600 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.