Kara Langer
Clinical Operations Leader
Camas,WA
Summary
Strategic leader with a passion for building collaborative, results-oriented teams that thrive in rapidly shifting environments. Promoter of operational excellence and patient-focused solutions. Over a decade of experience in end-to-end project management of complex early-phase, proof-of-concept, natural history, and registrational clinical trials. Proven success in building strong partnerships with internal stakeholders, CROs, vendors, and sites to drive efficiency, regulatory compliance, and data integrity in high-stakes clinical programs.
Overview
17
17
years of professional experience
Work History
ASSOCIATE DIRECTOR, CLINICAL OPERATIONS
BridgeBio Gene Therapy
01.2023 - Current
- Supports Sr. Director, Clinical Operations in oversight of Phase I/II/registrational gene therapy and natural history trials
- Identifies and plans for resourcing needs, oversees a team of 15+ individual vendors and consultants
- Manages 2 CROs with 10+ individual contributors across clinical monitoring, data management, biostatistics, site management, project management, and pharmacovigilance
- Supports all logistical aspects of global recruitment and enrollment of pediatric rare disease gene therapy trial (20 participants from 12 countries, 7 unique languages) and comparator natural history study (66 participants from 17 countries, 11 unique languages)
- Contributes to all Protocol Amendments (12 to date) and corresponding Informed Consents across 2 studies including collaborative authoring, review and document management
- Performs budgeting and forecasting activities for Clinical Operations department, representing 13M+/year
- Established central motor function rating program - interviewed and contracted with 5-person team of physical therapists, scoped activities for tech support, built budget forecasting model, oversaw development of charter, statistical analysis plan, and ACAM system
- Actively involved in the identification and establishment of a 5-person team of central motor function raters, key contributor to central rating charter, oversight of ACAM system build
- Champions patient and caregiver experience in clinical trial participation; Engages actively with members of the rare-disease advocacy community, especially Canavan patients/families
SENIOR PROJECT MANAGER
Veristat, LLC
09.2018 - 01.2023
- Led multi-disciplinary teams, ensuring collaborative planning and timely execution of 9+ full-service clinical trials
- Developed comprehensive project plans, identifying risks and mitigation strategies and ensuring regulatory compliance
- Ensured quality and compliance of deliverables from cross-functional team members
- Presented monthly status reports to executive leadership, providing insights into financial health of studies and progress made toward achieving key milestones
- Prepared, planned, and executed site initiation visits for 3 different complex protocols/trials
- Client satisfaction led to 3 non-compete project awards for 2 clients
- Speaker at 2 conferences on the topic of decentralized clinical trials and the benefits for rare disease populations
PROJECT MANAGER
Covance Clinical Development Services (A Division of LabCorp)
04.2014 - 09.2018
- Led multidisciplinary teams, ensuring collaborative planning and execution of 10+ multi-site clinical trials (including several global) from start-up to close-out
- Provided detailed project status updates to stakeholders and executive management
- Developed project plans, site-facing tools, and subject-facing materials in accordance with study Protocol and all applicable SOPs/regulations; Regularly updated suite of project documents to adapt to changes in Protocols and study objectives
- Coordinated cross-functional teams and resolved conflicts, maintaining a positive work environment throughout the project lifecycle
- Planned, prepared, and executed remote and in-person investigator meetings for multi-site studies
- Resourcing planning and oversight for Clinical Monitoring teams with up to 6 individual CRAs for studies with up to 20 sites
- Subject Matter Expert of global PM team for implementation of new Veeva CTMS and eTMF – prepared and delivered monthly trainings for global group of 120+ colleagues, demonstrated real world application of new technology
PROJECT COORDINATOR
Covance Early Clinical Development
09.2011 - 04.2014
- Supported Project Directors/Managers with execution of 10+ global, multi-site clinical trials
- Primarily responsible for site identification and management during start-up, including creation of investigator site files, regulatory document collection and review, and submission to IRBs
- Managed all aspects of site payments, site contracts, budget development, review, and negotiation
- Developed multiple site and participant facing tools and guidance documents
- Mentored and trained for 4 junior Project Coordinators
- Maintained accurate documentation of all projects, facilitating efficient audits and future reference
- Negotiated site budgets securing favorable terms for cost-effective trial execution
- Subject Matter Expert for site budget and contracting process
QUALITY ASSURANCE AUDITOR
Covance Laboratories, Inc.
09.2008 - 09.2011
- Performed data, report, and laboratory inspections for pre-clinical pharmaceutical trials to verify compliance to federal regulations and company SOPs
- Led two interdepartmental liaison groups
- Delivered quarterly GLP training to groups of 20+ cross-functional team members
Education
B.S. - Natural Sciences –Genetics
University of Wisconsin-Madison
Madison, WI01.2006
Skills
Strategic leadership and operations management
Collaborative decision-making
Relationship building
Project management
Budget development and management
Project cost management
Risk identification and mitigation
Change management
GxP compliance
Timeline
ASSOCIATE DIRECTOR, CLINICAL OPERATIONS
BridgeBio Gene Therapy
01.2023 - Current
SENIOR PROJECT MANAGER
Veristat, LLC
09.2018 - 01.2023
PROJECT MANAGER
Covance Clinical Development Services (A Division of LabCorp)
04.2014 - 09.2018
PROJECT COORDINATOR
Covance Early Clinical Development
09.2011 - 04.2014
QUALITY ASSURANCE AUDITOR
Covance Laboratories, Inc.
09.2008 - 09.2011
B.S. - Natural Sciences –Genetics
University of Wisconsin-Madison
Therapeutic Area Experience
Gene Therapy, Rare Disease, Natural History, Vaccine, Immunotherapy, Oncology, Migraine, Schizophrenia, Human Abuse Potential
Technical Proficiencies
MS Office including MS Project, EDC, eTMF, CTMS, RIM, Budgeting Software
Volunteerism
Executive Board Member, PTA
Former Girl Scout Troop Leader