Meghan Swardstrom
Seattle,WA
Summary
Accomplished Clinical Development and Operations Leader with progressive industry background experience and decisive leadership style. Offers collaborative strategic planning and forward-thinking mindset. Ready for challenges and focused on team building excellence and achieving initiatives.
Culture focused and willing to relocate for a great culture match.
Overview
27
27
years of professional experience
Work History
Principal Consultant
Emerald Clinical Consulting, LLC
01.2015 - Current
- Provide strategic clinical development and operations guidance to Biotech clients
- Serve as trusted advisor for clients navigating complex industry landscapes
- Serve as SME during B2B discussions
- Develop RFPs and Negotiate CRO contracts with vendors for optimal terms and conditions while facilitating reduced costs
- Ensure alignment of critical clinical development documents with regulatory strategy and corporate goals
- Develop infrastructure strategy and process; mentor clinical team member
- Interim Clinical Development Operations leadership for Biotech executives on leave
- Conduct clinical vendor and clinical site quality assurance audits.
Vice President, Clinical Development
Reunion Neuroscience
08.2021 - 08.2022
- Responsible for contributing to corporate functional development
- Responsible for establishing clinical phase research capabilities, including build of process, procedures, and teams to responsibly design, implement, and oversee clinical trials
- Responsible for development of Regulatory Strategy Plan, Indication Selection, Clinical Development Plan
- Responsible for IND Regulatory Management
- Responsible for developing and managing Clinical Development/Medical Affairs budget and work plans
- Responsible for oversight of all Clinical Development deliverables
- Responsible for clinical trial design and protocol
- Responsible for development of conference and publication plan
- Responsible for identifying, establishing, and managing Scientific and Clinical Advisory Board
- Responsible for relationship-building activities with Clinical Sites, KOLs, Vendors
- Actively mentor and ensure career development opportunities for Clinical Development Team.
- Cultivated strong relationships with key stakeholders, including customers, vendors, regulators, and community leaders to promote collaboration and long-term success.
- Collaborated with senior management to develop strategic initiatives and long term goals.
Vice President, Clinical Development and Operations (CDO)
Impel NeuroPharma
12.2017 - 05.2021
- Responsible for CDO leadership and team oversight, including budget development and staffing plans to support Impel’s multiple Clinical Development programs
- Responsible for CDO cross functional relationships and stakeholder representation
- Responsible for development of and management to CDO Key Performance Indicators (KPIs) to support Impel’s corporate goals
- Responsible for clinical trial design and protocol
- Responsible for oversight of staff and functional teams, including contract SMEs, Clinical Operations, Clinical Data Management, TMF Operations, Clinical Supply Chain Management, and CDO Process and Compliance
- Provided guidance as needed, directly or indirectly using consultant SME
- Responsible for assigning or directly providing back up to CDO team members
- Ensured CDO team was provided with mentorship and career development opportunities
- Responsible for relationship building activities with Clinical Sites, KOLs, Vendors.
Senior Director, Clinical Development and Operations
Northwest Biotherapeutics
07.2011 - 07.2016
- Developed, Managed and oversaw clinical development of multiple global immunotherapy/cell therapy solid tumor programs and continued clinical product development
- Responsible for CDO leadership and team oversight, including budget development and staffing plans to support NWBO’s multiple Clinical Development programs
- Responsible for CDO cross functional relationships and stakeholder representation
- Responsible for development of and management to CDO Key Performance Indicators (KPIs) to support NWBO’s corporate goals
- Responsible for clinical trial design and protocol
- Responsible for oversight of staff and functional teams, including contract SMEs, Clinical Operations, Clinical Data Management, TMF Operations, Clinical Supply Management, and CDO Quality, Process, and Compliance
- Provided guidance as needed, directly or indirectly using consultant SME
- Responsible for assigning or directly providing back up to trial team members
- Responsible for relationship building activities with Clinical Sites, KOLs, Vendors.
- Developed strong relationships with key industry partners, fostering collaboration and mutual growth opportunities.
- Managed risk effectively by identifying potential threats, developing contingency plans, and implementing mitigation strategies in line with overall business objectives.
Research Manager-Interim
Seattle Children's Research Institute
12.2010 - 07.2011
- Oversaw management of grant-funded Pediatric Psychiatry research studies, including departmental staff comprised of clinical research coordinators, clinical data coordinators, clinical trial assistants, scheduling coordinators, and social workers.
Lead Senior Clinical Research Associate – Pulmonology
Gilead Sciences, Inc.
09.2006 - 11.2009
- Oversaw new development program and provided back up and support for other programs in development.
Lead Clinical Research Associate - Ophthalmology
Light Sciences Corporation
09.2004 - 05.2006
- Implemented clinical operations function for new ophthalmology division.
- Monitored progress against project timelines, ensuring timely completion of deliverables while maintaining high-quality standards.
- Validated incoming data to check information accuracy and integrity while independently locating and correcting concerns.
- Implemented standardized documentation practices across the team to enable easier collaboration between researchers.
- Enhanced research efficiency by streamlining data collection and analysis processes.
Lead Clinical Research Coordinator
University of Washington Medical Center
07.1997 - 02.2004
- Implemented and oversaw investigator and industry sponsored clinical trials from contract and budget negotiation to clinical trial close out
- Ensured timely data entry into CRFs/eCRFs and resolved all queries
- Kept all regulatory documents filed and submitted as appropriate.
Education
Bachelor of Arts - Zoology
University of Washington
SeattleDoctor of Medical Science (DMSc) -
Northeastern University
Boston05.2025
Skills
- Process development and Implementation
- Strategic development
- Vendor Selection and Management
- Technology Implementation
- Organizational Development
- Program coordination
- Team Leadership, Mentoring & Development
- Resourcing
- Integrity and Honesty
- Cross Functional Collaboration
- Quality Assurance
- Timeline Development
Publications Abstracts Acknowledgements
Available on Request
Memberships Certifications
- Member CHIEF Executive Leadership – Current
- Member Women in Bio (WIB) - Current
- Member ACRP – Current
- Member SoCRA – Current
- Member RAPS – Current
- Pharmacovigilance Certification – 2023
- CRA Certification 2006 – 2012
Timeline
Vice President, Clinical Development
Reunion Neuroscience
08.2021 - 08.2022
Vice President, Clinical Development and Operations (CDO)
Impel NeuroPharma
12.2017 - 05.2021
Principal Consultant
Emerald Clinical Consulting, LLC
01.2015 - Current
Senior Director, Clinical Development and Operations
Northwest Biotherapeutics
07.2011 - 07.2016
Research Manager-Interim
Seattle Children's Research Institute
12.2010 - 07.2011
Lead Senior Clinical Research Associate – Pulmonology
Gilead Sciences, Inc.
09.2006 - 11.2009
Lead Clinical Research Associate - Ophthalmology
Light Sciences Corporation
09.2004 - 05.2006
Lead Clinical Research Coordinator
University of Washington Medical Center
07.1997 - 02.2004
Bachelor of Arts - Zoology
University of Washington
Doctor of Medical Science (DMSc) -
Northeastern University
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