Mark Bray
Normandy Park,WA
Summary
30 Years of Clinical Research Management ————————————————————————— Global Project Management Global Program Management. Global Portfolio Management Cross Functional Resource Planning Risk Identification and Mitigation International Vendor Management International Cross-Functional Drug Development
Overview
27
27
years of professional experience
1
1
Certificate
Work History
Senior Clinical Project Manager
Athira Pharma
03.2022 - 09.2023
- Ongoing identifying/coordinating interdependencies between various projects (studies) that contribute to the overall clinical pharmacology program of the investigational compound
- Proactively managed program-level operational aspects of theclinical trial team including management of trial timeline, budget, resources, and international vendors
- Provided efficient updates on trial progress to senior staff concerning vendor selection, project plans, trial budget and timeline management, quality standards, and risk mitigation
- Created/Chair Clinical Pharmacology Working Group to address program needs of 7 study cross-functional studies with multiple vendors delivering cross-functional resource planning where none previously existed
- Eliminated extensive bottlenecks in vendor payments by working closely with Accounting team and Legal team
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols
- Participated in initiation visits and investigator meetings, implementing trials in accordance with study timelines and budgets
- Skilled at working independently and collaboratively in a team environment
- Proven ability to learn quickly and adapt to new situations
- Worked well in a team setting, providing support and guidance
- Worked effectively in fast-paced environments
- Demonstrated respect, friendliness and willingness to help wherever needed
Senior Global Clinical Project Manager, Program Manager, Portfolio Manager
Biogen
01.2010 - 06.2015
- International Hemophilia Program
- Adjusted international strategy plans to improve the overall delivery of the program’s intended benefits within agreed-upon timelines, forecasts for all 14 clinical studies under my purview
- Managed details while taking a very holistic, benefits-focused view 14-18 clinical studies
- Interacted seamlessly and collaboratively with international program steering committees and other executive stakeholders, i.e., preclinical, regulatory, manufacturing, commercialization
- Identified program outputs and outcomes to provide study outcomes aligned with portfolio goals and objectives, leading to the filing NDA dossier
- Managed expectations and communications to increase stakeholder support internationally
- Updated professional RAC certification to include the latest ICH Guidelines as well as FDA Guidance
- Paid attention to detail while completing assignments
CTI BioPharma Inc
02.2004 - 11.2009
- BioPharma working on hematological cancers
- Delivered 14 international studies 2-10 months early to surpass the initial goal for FDA filing
- Insight into complexities of change management, impact of said changes, approach for implementing and communicating program changes, and lessons learned follow-up
- Developed program/project charters that fed into project/program roadmaps for various clinical studies on an international scale
- Assisted with FDA dossier’s creation and submission
- Identified issues, analyzed information and provided solutions to problems
Clinical Project Manager, Sr. Clinical Project Manager, Program Manager
NIH/DAIDS
01.2002 - 01.2004
- Delivered 14 international studies 2-10 months early to surpass the initial goal for FDA filing
- Insight into complexities of change management, impact of said changes, approach for implementing and communicating program changes, and lessons learned follow-up
- Developed program/project charters that fed into project/program roadmaps for various clinical studies on an international scale
- Social & Scientific Systems, Hired to work directly with NIH/DAIDS on national and international HIV Studies
Global Project Manager, Program Manager
ICOS Corp
08.1996 - 12.2001
- Designed/implemented/evaluated 46 project plans for ongoing international studies acting as primary liaison with various vendors and teams, and international regulatory agencies
- Worked directly with FDA/OHRP reviewing 13 network sites' performance, planning corrective action plans, and evaluating those plans
- Completed Regulatory Affairs Certification Program via GWU
- Reviewed NDA dossier’s
Medical Team Liaison, Data Manager, Project Manager
Eli Lilly
- Brought Cialis to Market and overseeing migration to Eli Lilly Inc.
- Contributed to the creation of Cialis from early animal models to international studies to assisting in the creation of FDA dossier and eventually overseeing migration to Eli Lilly
- Coordinated various teams, i.e., preclinical, regulatory, manufacturing, commercialization
- Collected, arranged, and input information into database system
- Gathered, organized and input information into digital database
- Developed and updated tracking spreadsheets for process monitoring and reporting
- Cultivated positive relationships with vendors to deliver timely and cost-effective supply of services and materials
- Provided reporting for forecast analysis and ad-hoc reporting in support of decision-making
Education
Master Of Science - Nursing, RNB
University of Colorado
Denver, CO1987
MSN -
ARNP Oncology Certification Primary Care ARNP 10 -
Associate Degree - Nursing
Bellevue College
Bellevue, WA1980
TECHNOLOGIES, KEYWORDS ————————————————————————— PMP certification PgMP certification Began Lean Six Sigma Green Belt certification PfMP Certification Regulatory Affairs Certification ARNP Oncology Certification -
Skills
- Contract Coordination
- Stakeholder Communications8
- Simultaneous Development Team Management
- Project Cost Management
- Risk Management
- Supply Chain Management
- Manage Contracts
- Project Management
- Agile Methodology
- Manage Budgets
- Cost Management
- Scope Management
Accomplishments
- Reduced department operating costs by 15% in 8 months.
Affiliations
- Project Management Institute
- International Council of Nurses
Certification
- PMP - Project Management Professional
- PgMP - Program Management Professional
- PfMP - Portfolio Management
- professional
- RN License - 35+ years
- ARNP License 18 years
- Oncology Training - 1992 - 2015
- Hematology Training 2000 - 2015
Work Availability
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Work Preference
Work Type
Full TimeContract WorkWork Location
HybridImportant To Me
Work-life balanceCompany CultureHealthcare benefitsWork from home optionTimeline
Senior Clinical Project Manager
Athira Pharma
03.2022 - 09.2023
Senior Global Clinical Project Manager, Program Manager, Portfolio Manager
Biogen
01.2010 - 06.2015
CTI BioPharma Inc
02.2004 - 11.2009
Clinical Project Manager, Sr. Clinical Project Manager, Program Manager
NIH/DAIDS
01.2002 - 01.2004
Global Project Manager, Program Manager
ICOS Corp
08.1996 - 12.2001
Medical Team Liaison, Data Manager, Project Manager
Eli Lilly
Master Of Science - Nursing, RNB
University of Colorado
MSN -
ARNP Oncology Certification Primary Care ARNP 10 -
Associate Degree - Nursing
Bellevue College
TECHNOLOGIES, KEYWORDS ————————————————————————— PMP certification PgMP certification Began Lean Six Sigma Green Belt certification PfMP Certification Regulatory Affairs Certification ARNP Oncology Certification -
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