Program and Project Management
Protocol Implementation and Study Startup
Vendor and Partner Management
Authoring SOPs
Regulatory Affairs
Hi, I’m
Melanie Dyjak
Everett,Washington
Summary
Overview
15
years of professional experience
8
years of post-secondary education
1
Language
Work History
Partner TherapeuticsLexington, MA
Associate Director, Clinical Project Manager
05.2021 - Current
Job overview
- Own and achieve deliverables throughout project lifecycle, in accordance with timelines, budget, and scope
- Proactively identify, mitigate, and manage risks and/or issues
- Develop and adhere to SOPs, policies, regulations, and guidelines
- Lead departmental initiatives: SOP development, training, and process improvement activities
- Oversee vendor teams and lead cross-functional internal teams
- Implement quality processes: vendor selection and qualification; clinical audit outcomes; clinical quality event reporting; and risk assessment following RACT
- Develop and manage study documents: protocol, IB, ICFs, IFUs, etc...
- Develop quality forms and templates: CTA, budget, FMV process, feasibility, site activation, study plans, site-facing documents; patient-facing documents
- Manage vendor/site contracts, vendor budgets
- Support clinical monitoring visits, inspection readiness, site financial reconciliation, and data management activities
- Contribute to clinical development strategy and fiscal planning
- Manage IND submission timelines and study startup activities
- Train and mentor team on GCP, project management, and operational best practices.
Fred Hutchinson Cancer Research Center, FHCRCSeattle, WA
Project Manager, Clinical Research Analyst
02.2016 - 04.2020
Job overview
- Lead study startup programs for three investigator-initiated & over 15 multi-center industry adoptive T-cell protocols
- Built and managed IND authoring for FDA submission readiness and overall program and project timelines
- Lead project meetings with a cross-functional team: Regulatory, Finance, Manufacturing, Clinical Operations, Legal, Lab Research, and Business Development
- Communicated to leadership, internal team, and external funding partners about project progress and strategic planning; ensured alliance and managed expectations
- Drove completion of project deliverables and adherence to agreements and timeline
- Developed and ran process improvement efforts: protocol development and after-action reviews.
- Managed risk and issues successfully overcoming through communication and teamwork
- Liaised with PIs (principal investigators), research, clinical, and administrative staff across SCCA, UW Medical Center, and Seattle Children's; maintained positive relationships to foster efficient processes and project completion
- Audited quality of site clinical billing grids, research pricing, ICFs, and clinical orders
- Assisted in hiring, training, and overseeing junior team members
Pharmaceutical Product Development, PPDMorrisville, NC
Medical Communications Specialist
01.2014 - 01.2015
Job overview
- Managed post-approval medical device product safety/quality data for a top ten global pharmaceutical company
- Coordinated pharmacovigilance, quality control, and regulatory teams per client/FDA guidelines
- Served as patient-facing expert on medical/technical information for nearly 20 medical devices/specialty drugs in endocrine therapeutic area
- Monitored quality and verified team performance data – closely adhered to SOPs
- Co-led drug labeling/device classes for new team members
- Mentored on Electronic Data Capture Systems, GXP and drug/device characteristics
Maple Bear Canadian SchoolsSeoul
Academy English Teacher
01.2010 - 01.2012
Job overview
- Mentored new teachers on overcoming challenges presented in the classroom
- Taught immersion English lessons and worked with students on writing, listening, and speaking
- Wrote classroom curriculum plans and collaborated professionally and positively with colleagues
University of California, San Francisco, UCSFSan Francisco, CA
Clinical Research Coordinator
01.2008 - 01.2010
Job overview
- Recruited, consented, and collected data from subjects in compliance with cGCP and regulations
- Consulted regularly with PIs/research team; ran weekly meetings and managed research clinic supplies
- Collaborated with PI to translate a new NIH-sponsored protocol into a site IRB submission/approval
- Responsible for all IRB regulatory documents for group and concentrated on site data management and query resolution
Education
University of Washington
Master of Science from Biomedical Regulatory Affairs
01.2017 - 01.2021
University Overview
University of California
Bachelor of Arts from Anthropology
01.2003 - 01.2007
University Overview
Skills
Strategic leadership
undefinedVolunteer Work and Travel
Volunteer Work and Travel
Independent Study and Travel – Europe, Asia, Northern Africa, and U.S. 2012–2013
● Field-studied health/sanitation of medical treatment facilities of various regions; informally studied Traditional Chinese Medicine alongside martial arts
San Francisco General Hospital and AIDS Foundation – CA 2007–2008
● Aided in research and co-infected support group; provided HIV information, risk assessment, and counseling
Timeline
Associate Director, Clinical Project Manager
Partner Therapeutics
05.2021 - Current
University of Washington
Master of Science from Biomedical Regulatory Affairs
01.2017 - 01.2021
Project Manager, Clinical Research Analyst
Fred Hutchinson Cancer Research Center, FHCRC
02.2016 - 04.2020
Medical Communications Specialist
Pharmaceutical Product Development, PPD
01.2014 - 01.2015
Academy English Teacher
Maple Bear Canadian Schools
01.2010 - 01.2012
Clinical Research Coordinator
University of California, San Francisco, UCSF
01.2008 - 01.2010
University of California
Bachelor of Arts from Anthropology
01.2003 - 01.2007
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