- Bothell, Washington State
- The hiring pay range for this position is $218,000 - $281,600 per year
- Closing date
- Jun 11, 2023
- Medical Director, Biomedical Sciences, Administrator/Manager, Director
- Breast, Clinical Research Oncology, Clinical Trials Research, Dermatologic Oncology, Gastrointestinal, Genitourinary, Gynecologic Oncology, Head and Neck, Hematologic Oncology, Immuno-Oncology, Laboratory-Based Research, Leukemia, Liver, Lymphoma, Medical Oncology, Melanoma, Multispecialty, Neurologic Oncology, Nurse Practitioner, Nursing, Palliative Care, Pancreatic, Pediatric Oncology, Pharmaceutical, Physician Assistant, Preventive Care, Radiation/Radiotherapy, Radiology, Sarcoma, Surgical Oncology, Therapeutic Oncology, Thoracic, Translational Research, Urologic Oncology, Other, Biochemistry, Biotechnology, Genomics, Informatics, Medical Clerical/Office, Oncology Administration, Radiation Oncology, Pathology, Rheumatology, Lung, BMT, Cell Therapy, Myeloma
- Full Time
- PHD, MD / PHD, PhD in Computational Biology, Biostatistics, Bioinformatics, BSN
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 (Medical) Director, Safety Evaluation & Risk Management (SERM) will be responsible for strategic and innovative medical leadership for global pharmacovigilance and risk management activities for assigned Seagen, Inc. investigational and marketed products.
This individual will function in a company matrix team environment interacting and leading with decisional ability with several key internal stakeholder groups including Clinical Development Medical Affairs, Regulatory Affairs, Product Quality Compliance, Quality Assurance, Commercial, Translational & Experimental Medicine and Legal.
Provide oversight and empowers decision-making from members of the Safety Evaluation and Risk Management (SERM) group in Global Safety Risk Management
Represent Global Safety Risk Management in Clinical Sub Team for assigned investigational products providing expert medical guidance in planning and gaining alignment for all safety matters and issues
Lead Safety Management Team navigating complex safety issues, despite ambiguity, for assigned pre-marketing and/or post-marketing product(s) and all associated risk management activities
Provides insightful guidance regarding the Signal Management System with regular review of safety data for assigned products for identification and evaluation of new safety signals
Perform/provide oversight for medical review for causality assessment of individual safety reports from clinical trials or post-marketing sources
Contribute to preparation and review of periodic reports (PADER; PSUR; Annual IND report; 6-monthly line-listings; EU Annual Safety Report; DSUR; Product Quality Report)
Contribute to protocol development ensuring alignment with risk management plans
Review and contribute medical content, as needed, for key study-related documents, e.g., Risk Profile, IB, ICF, SMC/IDMC Charters
Contribute to analysis of safety data from on-going and completed clinical trials and presentation in Clinical Study Reports
Contribute, assure quality, support production, and assure maintenance of risk management plans and safety communication in partnership with Regulatory Affairs (marketing applications, company core safety information, regulatory safety queries, etc.) to regulatory agencies or third parties
Participate in continuous improvement activities including systems design, operational and business processes, performance measurement and quality management
Provide guidance, and mentor staff, supporting their career goals, as well as, building on pharmacovigilance and risk management best practices and safety science
Provide input to Pharmacovigilance agreements and interactions
Contributes, is innovative and persuasive in navigating safety concerns/issues to closure in alliance safety teams with external partner(s)
Champions and is agile & strategic in driving results cross-functionally, meeting, or exceeding project timelines
Contributes/leads special projects with organizational impact
Contributes and leads activities required for a product registrational filing
8 years of relevant experience in Global Safety Risk Management, Clinical Safety, Pharmacovigilance or Risk Management preferred
Clinical research experience with exposure to clinical data collection, assessment, and analysis desired
Oncology safety science experience preferred
Prior experience with business partners a plus
Knowledge of ICH, US & EU regulations, and requirements for pharmacovigilance (experience with world-wide safety reporting regulations and guidelines required)
Excellent interpersonal skills, including ability to work effectively cross culturally and cross functionally
Proficiency in use of Excel and Microsoft Office
Excellent written and spoken English
Medical/Clinical degree (board certified/board eligible or ex-US equivalent), PhD in relevant area, PharmD, MPH/MSN, or BSN degree
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 $218,000 - $281,600 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.
Seagen is a global biotechnology company that develops and commercializes transformative cancer therapies. We’re driven by a singular mission—to make a difference for people impacted by cancer.
As an industry leader in antibody–drug conjugate (ADC) technology, we pioneered the science of harnessing antibodies designed to deliver cell-killing agents to cancer cells. Three of our four approved medicines are built on this technology.
We also focus our research efforts on novel targeted small molecule therapies. In addition, we are leveraging our expertise in empowered antibodies to build a portfolio of proprietary immuno-oncology agents.
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