Karen Gunther
Wilmington
Summary
Accomplished leader in the pharmaceutical industry who is recognized for expertise in global and US-focused clinical study management and medical writing, encompassing strategic portfolio planning, study start-up, trial execution, regulatory reporting and development of external communication strategies. Demonstrated success in fostering innovation and organizational transformation, thriving as both an inspiring team leader and a dedicated individual contributor committed to delivering transformative therapies to patients.
Overview
42
42
years of professional experience
Work History
Director, Global Medical Writing
Boehringer Ingelheim Pharmaceuticals, Inc.
Ridgefield
07.2022 - 12.2025
- Led international team of regulatory medical writers in executing end-to-end clinical document strategy for 20+ projects.
- Provided strategic oversight and direction for Mental Health & Eye Health Global Medical Writing Team
- Led the Global Clinical Authoring Initiative, incorporating AI-assisted authoring opportunities.
- Facilitated cross-functional communication to ensure stakeholder alignment on planning and execution of deliverables.
- Ensured timely and quality-focused business planning and resource allocation across projects.
- Refined operational procedures and implemented new tools to enhance medical writing practices.
- Co-led Planning & End-to-End Frontloading Initiative, focusing on excellence in study start-up processes.
Sr Associate Director, Study Management & Conduct
Boehringer Ingelheim Pharmaceuticals, Inc.
Ridgefield
09.2013 - 07.2022
- Directed global operational planning and execution of clinical trials amidst pandemic challenges and competitive landscape.
- Employed innovative strategies to support study start-up and delivery of priority cardiometabolic, respiratory, and inflammation trials in the US.
- Collaborated with cross-functional teams to accelerate COVID-19 trial timelines.
- Oversaw global clinical operations for CTMS COVID-19 workstream, enhancing operational efficiency and supporting inspection readiness.
- Facilitated Subject Injury Review Committee discussions, guiding safety reviews and recommendations.
- Led US Patient-Focused Drug Development workstream, ensuring alignment with regulatory standards.
Associate Clinical Director
PeakVue Productions
Englewood
08.2009 - 12.2012
- Oversaw educational initiatives, including promotional and continuing medical education programs, enhancing stakeholder engagement.
- Planned and moderated advisory board meetings, producing executive summaries to guide strategic decision-making.
- Collaborated with key external experts to enhance content development and relevance.
- Conducted needs assessments to identify critical educational gaps, informing targeted educational initiatives.
Scientific Supervisor - Respiratory
International Meetings and Science
Stamford
02.2007 - 03.2009
- Executed and oversaw promotional education initiatives for respiratory product portfolio, increasing awareness and engagement.
- Guided strategy for disease state and product support, enhancing alignment with client objectives.
- Developed specialized curriculum for targeted audiences, fostering collaboration and knowledge transfer.
Respiratory Medical-Marketing Consultant
Karen L. Gunther, Inc.
Parker
08.2002 - 11.2006
- Provided medical project support for phase IIIb/IV multinational lung function trial.
- Contributed to US publications and professional communications for leading COPD therapeutic modality.
Associate Director, Clinical & Scientific Affairs
Boehringer Ingelheim Pharmaceuticals, Inc.
Ridgefield
10.1994 - 08.2002
- Led the global Publications/Professional Communications Team to support the launch of a leading COPD therapeutic modality.
- Managed clinical trials focused on respiratory disorders, including COPD and ARDS
- Evaluated US promotional materials and grants as respiratory medical lead, ensuring compliance and scientific accuracy.
- Conducted medical safety reviews for marketed respiratory products and product complaints.
- Developed clinical sections of IND/NDA annual reports and conducted label reviews for marketed respiratory products.
- Collaborated on market development strategies within the US respiratory franchise team.
Clinical Research Associate - Consultant
Synergen, Inc
Boulder
02.1994 - 10.1994
- Evaluated clinical trial sites for adherence to Good Clinical Practices, enhancing trial integrity.
- Conducted site visits to validate compliance and ensure participant safety in clinical trials.
- Monitored clinical trial data accuracy and participant safety, ensuring compliance during phase III sepsis trial site visits.
Clinical Research Nurse - Pulmonary/Critical Care
University of Cincinnati
Cincinnati
01.1989 - 02.1994
- Coordinated and executed clinical research and case management activities for ARDS, Sepsis, and COPD, ensuring adherence to protocols and timelines.
Registered Nurse
Humana Hospital
Augusta
06.1984 - 11.1988
- Managed ICU step-down, ventilator support, diabetes care, and medical-surgical units to ensure comprehensive patient care.
Education
Bachelor of Science - Nursing
Medical College of Georgia
05.1988
Associate of Applied Science - Nursing
Northern Kentucky University
05.1984
Skills
- Strategic leadership
- Anticipatory thinking
- Data-driven decision-making
- Stakeholder communication
- Operational excellence
- Process improvement
- Project management
- Training and mentoring
- Business planning
- Risk Management
Timeline
Director, Global Medical Writing
Boehringer Ingelheim Pharmaceuticals, Inc.
07.2022 - 12.2025
Sr Associate Director, Study Management & Conduct
Boehringer Ingelheim Pharmaceuticals, Inc.
09.2013 - 07.2022
Associate Clinical Director
PeakVue Productions
08.2009 - 12.2012
Scientific Supervisor - Respiratory
International Meetings and Science
02.2007 - 03.2009
Respiratory Medical-Marketing Consultant
Karen L. Gunther, Inc.
08.2002 - 11.2006
Associate Director, Clinical & Scientific Affairs
Boehringer Ingelheim Pharmaceuticals, Inc.
10.1994 - 08.2002
Clinical Research Associate - Consultant
Synergen, Inc
02.1994 - 10.1994
Clinical Research Nurse - Pulmonary/Critical Care
University of Cincinnati
01.1989 - 02.1994
Registered Nurse
Humana Hospital
06.1984 - 11.1988
Bachelor of Science - Nursing
Medical College of Georgia
Associate of Applied Science - Nursing
Northern Kentucky University