Heather Mueller

* Therapeutic Area/Indication/Stage: Primarily Small Biotech companies, Pre-Clinical (IND Submissions), Phase I-III, Adults and Children, Oncology-Hematology, Immuno-Oncology, Dermatology, Neurology, and Rare Disease

*Provides Director Level Oversight in the Project Management, Business Development, and Clinical Operations areas as requested/needed for applicable duties and projects.

*Oversight of planning, execution, and project delivery, ensuring timeline adherence to budget and quality
* Oversaw several projects to meet objectives, manage risks, and comply with regulations/SOPs

*Hands-on with all aspects of the study and willing to jump in and get involved with the team to make decisions and execute the trial in environments requiring agility
* Developed and executed business development strategies to expand the company's footprint
* Identified and pursued new business opportunities, building on existing relationships and creating new ones

* Collaborated with cross-functional teams to drive revenue growth and improve customer satisfaction

* Lead high-performing teams to achieve business objectives and exceed client expectations

* Oversight/implement project plans, i.e., clinical monitoring, project, risk, quality management, etc.

* Ensured accurate and complete project data, prepared/updated SOPs, and provided related training

* Collaborated with cross-functional teams to ensure data quality, integrity, and compliance

* Managed project financials, including budgeting, forecasting, and revenue recognition

* Communicated project progress/issues/risks to stakeholders, including sponsors, team, and management

* Led and motivated project teams, providing performance feedback and coaching to team members by overseeing everyday operations

*Working with the teams and communicating with management and QA/QC to identify and qualify vendors if not already on the approved Vendor List

* Therapeutic Area/Indication/Stage: Quantum Leap Healthcare Collaborative - Non-Profit Organization - Platform Study, Adults, Oncology

*Executed plans/timelines, meeting deliverables, tracked/analyzed accruals, and reported KPI updates

* Supported and prepared meeting documents for internal and external stakeholder meetings

* Monitored compliance for policies/processes, standards/guidelines, university policies/regulations

* Served as liaison between academic leaders

* Proposed solutions to difficulties arising from multidisciplinary research and/or from issues being escalated
* Implemented structural changes to maximize time efficiency within the constraints of limited resources

* Development of Work Instructions and subsidiary documents to Standard Operating Procedures

* Operated as development lead of new processes and protocols with the project team for complex clinical trials

* Oversaw and managed protocol amendments.

* Conducted extensive project feasibility assessments. Analyzes risks, strategies, and solutions

* Developed project timelines and key milestones for assigned projects
* Responsible for maintaining/updating protocol and Operations Manual, including assessing for updates

* Therapeutic Area/Indication/Stage: Functional Service Provider (FSP Model) - .60FTE (Bristol, Myers, Squibb) Phase I-III, Oncology, Dermatology, Cardiology and Immunology, (Full Service Model) - .25FTE (Novocure) Phase II-III, Oncology, Medical Device and (Small Biotech) .15FTE - IND Submission, Phase I, Oncology-Hematology, Immuno-Oncology, Cell and Gene Therapy (CGT)

* Role included tasks typically assigned to Senior Project Director (Business Development/Portfolio Financial Oversight, etc.) and Associate Project Director (day-to-day operations, project team lead oversight, cross-functional leads, clinical team managers, CRAs, etc. However, I was designated to the role of Project Director - Oncology due to the level of experience

*Developed/executed trial strategies, solutions, and business development, driving differentiation and growth
* Built/maintained relationships with clients, KOLs, vendors, and stakeholders for growth and satisfaction
* Lead cross-functional teams to deliver high-quality, price-competitive solutions and proposals
* Collaborated with leadership to drive initiatives, improve/expand business performance

* Fostered a culture of ownership, accountability, and continuous learning and development of talent

* Ensured consistency and excellence in quality, standards, policies, processes, and practices

* Managed recruitment strategies, campaigns, and communications across portfolios and with stakeholders

* Monitored risks and quality activities by identifying/implementing CAPAs for improved project delivery

* Analyzed market trends, competitor activity, and industry developments to inform business decisions

* Produced/distributed KPI reports, resourcing, and tracking reports to staff and senior management
* Oversight of PMs on scope, financial, and change management reviews/processes to align contracts/budgets

* Performed ongoing review of project financial status and alerted leadership to potential issues

*Worked with the team to manage and address the clinical supply chain for study-related materials manufacturing, IMP, logistics, surrounding collection and management of sample shipments, etc., with the various study vendors, ensuring quality, on-time services.

*Worked with the cross-functional teams within Clinical Operations, Data, and Project Management through the planning, execution, and close out of various database locks, including Interim Analysis for annual reports, DSMB, SRC, and CSR through on-site, remote, and risk-based monitoring strategies

* Therapeutic Area/Indication/Stage: Primarily Small Biotech Companies - IND Submissions, Phase I-III, Oncology-Hematology, Infectious Disease, and Dermatology, Decentralized Clinical Trials (DCT) and rescue studies.

* Overall oversight of projects from initiation to closeout, ensuring alignment with project WOs and KPIs
* Provided strategic leadership to cross-functional teams globally, driving project performance and results
* Oversight of training and meetings, for documentation completion, distribution, and filing
* Managed vendor qualification, selection, performance, and delivery of services throughout the project
* Oversaw creation, maintenance, and quality check of TMFs from initiation to final delivery or archival
* Monitored, analyzed, and reported project health, identifying required changes, and initiating change orders
* Developed, collected, and tracked site documentation, regulatory approvals, and IP release processes
* Coordinated with the clinical team to plan monitoring visits and perform trip report reviews
* Conducted periodic reviews of documentation generation and studies for compliance with plans and SOPs

* Therapeutic Area/Indication/Stage: Functional Service Provider (FSP Model) - (Bristol, Myers, Squibb) Phase III, Oncology

* Associate Directors typically hold the Project Lead role due to the complexity and responsibilities of global oversight of significant Phase III studies in all global regions. I functioned in this role due to my senior Project Manager—oncology designation.

* Developed/managed project plans, scope, and budgets, utilizing project management methodologies
* Directed project scope and financial reviews, implementing change management processes to align budgets
* Acted as liaison with Sponsors, Vendors, and Sites to ensure successful study launch, conduct, and closeout
* Managed contracts, financial aspects, and site payments for partnership projects
* Oversaw project documentation, including Trial Master Files, for completeness and audit-readiness
* Reviewed project documents, such as protocols, IBs, and CRFs, for consistency and accuracy
* Developed/maintained project plans, following SOPs, Work Instructions, and partnership SOPs/WIs

* Communicated independently with clients, presenting study material at BD meetings, and overall outcomes
* Attended and contributed to clinical meetings, project team meetings, committees, and training sessions

*Worked with the global team to communicate and contributed to maintaining not only the region updates regarding the daily tasks, processes, updates, reviews, etc., but also to ensure that these tasks and feedback were completed and provided efficiently, with quality, and resourcefully as possible.

* Therapeutic Area/Indication/Stage: (Full Service Model) - (Kite Pharma) Phase I-III, and Expanded Access, Oncology-Hematology, Cell and Gene Therapy (CGT)

* Oversaw Clinical Operations conduct, including SSU, Data Management, Regulatory, Quality, etc.

* Developed executive reports of KPIs to facilitate project evaluation and process improvement
* Developed and initiated projects, including managing costs, schedule, and performance
* Identified plans and resources required to meet project goals and objectives by setting KPIs
* Oversaw quality/compliance issues, CAPAs, Root Cause Analysis, and escalated to QC/QA, as applicable
* Managed contractual deliverables via metrics and adherence timelines, quality/scope, and cost deliverables
* Coordinated and managed the site selection process in collaboration with the necessary line units
* Drove the conduct of SSU activities and amendments, including preparing the IRB/EC submission package
* Oversight of Teams of CRAs and other internal Team Members, such as IHCRAs, CTA, etc., ensuring compliance with protocol, timelines, and other trial tasks, and managing metrics and timelines.

* Accountable for coordinating data management activities through the local trial team

* Communicated with monitors and Investigator sites to ensure timely resolution of data issues

* Therapeutic Area/Indication/Stage: Primarily Small Biotech Companies - IND Submissions, Phase I-II, Oncology-Hematology, Immuno-Oncology, Adults

* External Audit Facilitator, FDA (no 483s) and Local On-Site with institutions and vendors

* Developed, implemented, and monitored processes to ensure long-term project success and efficiency

* Led cross-functional teams, including third-party vendors, and managed project contractual deliverables
* Acted as primary liaison with clients, ensuring seamless communication and relationship building
* Oversaw the development and implementation of SOPs, regularly analyzing and improving processes
* Managed project budgets, forecast expenses, and mitigated risks proactively
* Conducted on-site visits to ensure protocol compliance and foster positive relationships with site staff

* Oversight of Clinical Operations, including the management of CRAs assigned to projects

* Coordinated and participated in audits, creating action plans to address findings
* Oversaw study lifecycle, from feasibility to close-out, and developed implementation processes and tools

* Therapeutic Area/Indication/Stage: Primarily Small Biotech Companies - Pre-Clinical and IND Submissions, Phase I-III, Oncology-Hematology, Immuno-Oncology, Cell and Gene Therapy (CGT), Adults and Pediatrics

*Provided oversight for SSU/Monitoring, ensuring compliance with SOPs, Regulatory/GCP requirements
* Acted as primary liaison between Sponsors, PIs, and sites to facilitate trial activities and resolve issues
* Managed direct reports, administrative oversight, and staff education/training to ensure high-performance
* Developed/executed monitoring plans, feasibility, site activation plans, and trial budgets
* Conducted inspections, produced/reviewed Informed Consent Forms, and managed the drug supply
* Collaborated to develop study implementation processes/tools and facilitate the development of SOPs

*Oversaw vendors' selection and management, including the Investigational Product, ancillary supplies, and other required supplies as indicated per protocol.

*Manage clinical trials in the United States and Canada, ensuring deliverables on time and within budget.

* Therapeutic Area/Indication/Stage: Non-Profit Organization - Phase I-IV, Oncology-Hematology, Immuno-Oncology, Cell and Gene Therapy (CGT), Adults and Pediatrics

* Served as primary point of contact for sponsors/CROs, providing protocol-specific information and support
* Led cross-functional teams of site managers and coordinators, ensuring project execution and alignment
* Oversaw direct reports, providing administrative guidance, staff education, and training
* Collaborated in early development meetings and submissions to IRB, FDA, and IBC
* Developed and implemented trials across network sites, ensuring education of clinical research staff
* Analyzed reports to identify areas of improvement and implemented process changes
* Managed trial budgets, facilitated SIVs, IMVs/RMVs, and reviewed monitoring reports
* Coordinated with sponsors/CROs to develop study implementation processes and tools
* Led and participated in MQA audits, creating action plans as needed

*Maintained productive relationships with CROs, providing oversight and risk assessments across the affiliated SMO sites within the network to ensure timely deliverables per the executed contract budget.

Managed clinical trials across the SMO from start to closeout, assessing risks, timelines, enrollment, data, etc., to ensure they met applicable internal goals or sponsor-appointed KPIs.

* Therapeutic Area/Indication/Stage: Non-Profit Organization - Phase I-IV, Oncology-Hematology, Immuno-Oncology, Cell and Gene Therapy (CGT), Adults and Pediatrics

* Managed clinical trials simultaneously, ensuring compliance with protocols, regulations, and guidelines
* Supervised and mentored a team of Clinical Research Assistants, guiding trial operations
* Compiled and reported protocol activity, accrual data, and research data to administrators and sponsors
* Conducted timely and accurate data collection, documentation, entry, and reporting
* Coordinated subject visits, prepared orders, and reviewed patient conditions with physicians
* Participated in monitoring and auditing activities, ensuring trial integrity and regulatory compliance
* Presented trial concepts to subjects, obtained informed consent, and educated clinical research staff
* Collaborated with staff to develop action plans for quality and performance improvement

* Therapeutic Area/Indication/Stage: Non-Profit Organization - Phase I-IV, Oncology-Hematology, Immuno-Oncology, Cell and Gene Therapy (CGT), Adults and Pediatrics

* Managed data by research protocols, operations manuals, and CRF requirements
* Educated patients on all aspects of clinical study participation and ensured their safety and well-being
* Assisted the study team in collecting and tracking subject data, maintaining accurate and organized records
* Communicated with data coordinators, study sponsors, and accrediting agencies to ensure data reporting
* Collaborated with research staff to prepare subject records for regulatory audits
* Coordinated appointments and lab testing with clinical research subjects
* Assisted physicians and surgeons with performing biopsies, tissue procurements, and specimen processing
* Prepared and shipped blood and tissue specimens to study sponsors

* Therapeutic Area/Indication/Stage: Phase I-IV, Oncology-Hematology, Immuno-Oncology, Cell and Gene Therapy (CGT), Adults and Pediatrics

* Assisted physicians with patient care duties, including exams, procedures, and patient education
* Maintained efficient patient flow and ensured seamless coordination of care
* Recorded and verified patient data, including vital signs, medical history, and informed consent forms
* Assisted with routine checks, diagnostic testing, and specimen collection for research and routine purposes

* Prepared and administered medications as directed by physicians or nurse practitioners
* Documented patient information accurately and efficiently in EMR systems for transcription to CRFs