Kelly M. Brady
Summary
A driven, goal-oriented clinical development and operations executive with documented track record of building and managing global cross functional teams (Clinical Operations, Clinical Research, Pharmacovigilance, Data Management, Biostatistics, Program and Alliance Management) resulting in high performance and successful outcomes in hematology, oncology, inflammatory, and infectious disease. Using a collaborative approach, risk mitigation, strategic decision making, and problem solving for the execution of sound clinical trials and clinical development success Over 18 years of increasing responsibility from early to late-stage research to marketing application approval and post-marketing requirements, leading with transparency, empowerment of internal and external partners, authenticity and patient centricity Strengths include developing cohesive teams, setting and tracking enrollment goals and metrics for performance, resource management including strategic outsourcing, data monitoring and analysis, submission and inspection preparedness and excellent communication and interpersonal skills for productive interactions with key stakeholders: sponsor team, CROs, vendors, clinical sites, senior leadership, Board of Directors, or potential business partners
Overview
17
17
years of professional experience
Work History
Senior Vice President, Clinical Development
Seres Therapeutics, Inc
02.2023 - Current
- Member of Seres Executive Committee representing office of Chief Medical Officer for Clinical Development, Regulatory and Operational strategy, as well as participation in Board of Directors meetings
- Leads the Clinical Operations, Data Management, Pharmacovigilance Operations, Biostatistics and programming departments to successfully design and execute multiple clinical trials to achieve corporate goals, including resource planning and lifecycle management
- Strategic planning of clinical trial operations, data management, and statistics including but not limited to staffing, timelines, trial oversight, operational plans, data analysis, trial metric reporting, vendor alliances management with the goal of delivering high quality programs
- Directs all aspects of timeline, budget, analyses, compliance, conduct, and reporting for clinical trials to ensure delivery of corporate objectives on time, within budget and in compliance with SOPs, FDA and ICH/GCP guidelines
- Lead author and contributor for regulatory filing documents including INDs, annual reports, and BLAs
- Oversees trial database builds, execution of statistical analysis plans and clinical readouts for Phase 1 through post-marketing studies, ensuring completeness, accuracy and consistency of all clinical data and data structures across all clinical projects, adhering to data standards
- Partners collaboratively with key internal functions such as Medical, Regulatory, Quality, R&D, CMC, and Program Management to implement the Company’s clinical strategies and drive organizational success
- Develop and review clinical outsourcing strategies and plans
- Management of CRO partner and partnership at Joint Steering Committee level; may also have direct contact with sites, including KOLs and site coordinators
- Represents Seres at conferences, investigator meetings, and regulatory engagements
- Maintains collaborative relationships with vendors, key opinion leaders, investigators, and other key individuals as necessary to ensure appropriate program progress and overall business and clinical objectives
- Represent clinical operations plans and status to partners and Seres leadership and BoD
- Responsible for departmental budgets inclusive of Clinical Development, Regulatory and Medical Affairs
- Optimize and implement SOPs, processes, communication, & infrastructure within Clinical Operations, Data Management, Biostatistics and programming to support company goals including regulatory filings
Vice President, Clinical Operations and Data Management
Seres Therapeutics, Inc
06.2018 - 02.2023
- Core team leader for Seres’ lead asset, SER-109, approved as VOWST in April 2023
- Member of Joint Governance Committees with co-commercialization and development partner, Nestle Health Sciences
- Member of Seres Biologics License Application (BLA) Leadership team
- Created and executed a clear, integrated clinical operational strategy for Seres’ products, including pivotal studies for approved product VOWST
- Provided leadership, strategic oversight, and guidance of Clinical Operations and Data Management to ensure quality, timeline, resources, and budget goals were met for clinical trials
- Directly led and managed operations involved in clinical operations, medical writing, statistics and other functional groups
- Acted as point of contact and project representative to governance and other decision-making bodies, including information dissemination and the resolution of critical project issues
- Oversaw, planned, and implemented quality checks for clinical projects and direction to ensure the highest standards of compliance with company’s SOPs, ICH GCP guidelines, regulatory authority regulations and patient safety standards
- Provided operation and clinical expertise to develop a life-cycle strategy and evaluation of new programs to be prioritized or advanced into clinical development
- Implemented best practices and standards for trial management in collaboration with other members for the clinical operations team, including establishment of SOPs
- Led initiatives to build clinical department infrastructure
- Planned clinical headcount and hiring needs to meet program workload demands; mentors and performance plans for junior staff
- Responsible for Clinical development budget
- Developed and maintained strong relationships with CROs, external experts and investigators to ensure effective execution of internal and external projects
- Collaborated with CMO and cross functional teams to generate high quality clinical study reports, investigator brochures, clinical, protocols, publications and presentations of clinical study results, and regulatory dossiers
Senior Director, Clinical Operations
Akebia Therapeutics
01.2017 - 05.2018
- Responsible for 4 Phase 3 global trials (>7000 pts) and supporting studies for registration enabling program, with emphasis on oversight of operational activities globally, reporting out to senior management and alliance partners
- Represented the Clinical Operations Function at the Akebia Global Product Team
- Leveraged resources, expertise and knowledge across projects, including specific operational strategies for executing clinical studies globally, with a focus on recruitment timelines and delivery of quality data
- Oversaw and coordinated budgetary activities for assigned programs including internal and vendor study budget creation, negotiation forecasting, accruals reporting and invoice approval; proactively provides senior management with necessary updates on progress and changes in scope, schedule, and resources in a timely manner
- Translated corporate and product development goals into relevant, tangible and measurable objectives for the operational team and third-party vendors and drives optimal delivery
- Led clinical operations strategic planning activities for clinical programs and translates strategic decisions into actionable operational plans
- Accountable for management of all clinical research activities including proactive identification of work streams and dependencies, key risk indicators, resources and milestones
- Managed clinical trial implementation with clinical sites, external consultants and CRO personnel to ensure timely implementation of clinical studies in accordance with GCP regulatory requirements
- Led the operational selection of various vendors and the review of proposal requests
- Collaborated with various in-house functional group leads and external advisors with regards to clinical study operational issues including safety reporting and processing and study drug supply plans, cross-functional communication/interaction plan and monitoring
- Collaborated with the SVP-Clinical Development and Chief Medical Officer, and head of regulatory to generate high quality clinical study reports, investigator brochures, clinical protocols and amendments, publications and presentations of clinical study results and regulatory documentation
- Prepared and delivered effective presentations to the Project Team, Senior Management, company partners, external parties, and at conferences
- Provided oversight of CROs using relevant metrics and tools and monitors progress toward Clinical Operations objectives
- Built and maintained relationships with clinical investigators/advisors/ESC and IDMC
- Oversaw creation of study documents, regulatory documents
Senior Director, Clinical Program Management
Acetylon Pharmaceuticals
03.2016 - 12.2016
- Led due diligence efforts with VP, Clinical Operations through acquisition process of Acetylon by Celgene
- Product Team Lead and oversight of two clinical programs (8 clinical trials, and 4 trial managers)
- Developed and implemented operational systems for the clinical function, including SOPs and consistent meeting structure and reporting methods
- Oversight of clinical trial vendor and CRO selection and performance
- Supervision and development of Clinical Operations staff; sits on Medical Leadership team
- Oversight of Clinical program/trial management including resource planning, budget/invoice, operational strategy from feasibility and site startup through final analysis
- Supported clinical trial leaders and department heads in establishing goals and timelines and in defining critical path issues and solutions
- Determined project action items across programs and monitors follow-up and resolution of action items
- Collaborated with VP, Clinical to integrate and communicate clinical department timelines and risks across the Company’s disease and technology area Project Teams
- Collaborated with the head of Quality Assurance regarding quality systems as they apply to Clinical Department function
- Supported the head of Regulatory Affairs with the coordination of clinical reports for inclusion in FDA and other regulatory filings; acted as a key reviewer for regulatory submissions or responses
- Acted as liaison with and supported CMC department with development of IP supply plans for all trials, including drug forecasting for the year ahead, and planned for substantial IMPD amendments in the EU
- Reviewed Program and Study Plans/Documents for Compliance with SOPs and for alignment with program and specific study goals
- Supported the VP of Clinical Operations in leading and motivating a cross functional team including internal clinical operations staff, CRO, vendors, and monitors
- Supported the Senior VP Clinical Development in periodic reviews of departmental goals and strategic plans, including needs for future hiring and training of clinical staff
- Acted as Acetylon liaison with the Leukemia and Lymphoma Society including providing content for quarterly meetings, working on contracts and budgets
Director, Clinical Program Management
Acetylon Pharmaceuticals
06.2015 - 03.2016
- Standardized operational processes and procedures across clinical programs
- Led the clinical operation meeting, including general training of the team, agenda topics, and process standardization
- Ensured trials were run in accordance with global regulations and ICH/GCP guidance
- Oversaw Clinical program/trial management including resource planning, budget/invoice management, operational strategy from feasibility and site startup through final analysis
- Managed junior staff as team expanded, in addition to management of multiple complex (global) clinical trials across therapeutic areas
- Oversaw preparation, review, and approval of study tools and documents
- Drove an effort to standardize Clinical Trial Working Groups across all trials for improvement of meeting discussion and attendee accountability
- Worked on interim, final reports, and analysis of clinical data including development of clinical posters/presentations for major conferences or advisory boards
- Selected and provided guidance for qualification of study related vendors and management of vendors to ensure successful study execution
- Improved the planning and organization related to scheduled data cuts, including a publication plan, medical reviews, urgent query issuing and closure. Participated successfully in medical review meetings, assisted the team as QC reviewer and timeline oversight for these activities
- Led efforts to improve CRO relationship and CRO quality of execution including implementation of Data Success Plans to improve query and DM performance and improved reporting trackers
- Developed the Vendor Oversight Plan template with Quality Department, and led implementation of a VOP across all ongoing trials
- Actively contributed to CRO monthly business calls with goal of improved CRO performance
- Provided program oversight and guidance to team on data delivery, protocol and clinical document writing, execution of operational tasks, and preparation for data deliverables
- Acted as Acetylon liaison with the Leukemia and Lymphoma Society including providing content for quarterly meetings, working on contracts and budgets
Lead Clinical Research Manager
Takeda Pharmaceuticals International Co.
06.2014 - 02.2015
- Global Clinical Lead for Phase III Study (Classical Hodgkins Lymphoma) run with alliance partner Seattle Genetics (29 countries, >240 centers, n=1240 pts)
- Led and Motivated a cross functional team including global internal staff, CRO, vendors, monitors
- Clinical program/trial management including resource planning, budget/invoice management, operational strategy from feasibility and site startup through final analysis
- Managed Independent Data Monitoring Committee and steering committee meetings and interactions, as well as outreach to KOLs
- Program management activities including coordination of safety submissions, preparation for FDA meetings, and Medical Science Liaison initiatives
- Participated in task forces and working groups to improve vendor performance, CRO/sponsor collaboration, and preferred provider activities
- Member/Lead of Rapid Response team and cross functional efforts for regulatory submissions and responses
- Takeda task force member for EHA and ICML Congresses
- Oversaw 2 regional clinical research managers, providing strategic guidance and performance reviews
- Reviewed Study Documents and Program Plans for Compliance with SOPs and for alignment with program and specific study goals
- Developed metrics KPIs and Oversight Plan to track performances of CRO/Vendor for quality management
Senior Clinical Research Manager
Takeda Pharmaceuticals International Co.
09.2013 - 05.2014
- Global Clinical Lead for Phase III Study (Classical Hodgkins Lymphoma) run with alliance partner Seattle Genetics (29 countries, >240 centers, n=1240 pts)
- Global Clinical Lead for Phase III Study (Peripheral T Cell Lymphoma), including 19 countries (>125 centers)
- Managed study start up of international phase III study(ies) with direct oversight of all clinical activities
- Responsible for effective management of study budgets, timelines, resources, and implementation of appropriate standards and processes to ensure clinical study quality
- Worked closely with Clinical Supplies for accurate forecasting, IP drug & supplies logistics and contingency planning.
- Management of vendors including central imaging, central laboratory, central pathology, external statistical team
- Presented study development and identified program risks for Clinical Senior and Marketing Leadership
- Planned and led multiple investigator meetings
- Implemented data cleaning plan with CRO in preparation for interim and futility analyses
- Participated in CRO preferred Provider selection and vetting process
- Actively reviewed CRFs, CCGs, Data Edit Check specifications, dynamic listings, Patient Profiles, and PK and SAE reconciliations
- Drove cross functional team to develop process flows (for lab transfers, imaging transfers, central pathology processes and study status tracking system), as well as Vendor Oversight Plan, Monitoring Plan, Quality Management Plan, Safety, Risk Management, and all study specific documents.
- Contributed to protocol writing, ICF preparation and regulatory submission.
- Worked with Takeda Local Operating Companies in emerging markets to overcome regulatory challenges and maximize local expertise and relationships
- Worked with QA to identify root causes, prepare CAPA process and audit plan for Inspection Readiness.
Clinical Research Manager
Millennium, the Takeda Oncology Company
02.2012 - 08.2013
- Global Clinical Lead for Phase III Study (Peripheral T Cell Lymphoma), including 19 countries (>125 centers).
- North America and South America Regional Lead for Phase III study in PTCL
- Collaborated with cross functional team to develop Process flows and Plans (Study / Monitoring / Safety (PV) / Risk Mitigation/Lab Charters and CLWs, and other study specific plans)
- Managed CRO & Vendor Oversight for compliance with ICH / GCP and follow SOPs
- Managed study through site startup, active enrollment, Protocol Amendments, ICF development
- CTA application planning, IRB/EC response development, ongoing data issues management and escalation, and audit planning
- Contributed to IVRS User Requirements, drug supply management and participated in IVRS UAT, and protocol amendment reviews
- Contributed to CRF design; Data edit check spec and CRF guideline.
- Responsible for data review, oversight of monitoring performance, monitoring plan
- Maintained tracking of study status and metrics, including monthly updates to senior management
- Performed co-monitoring visits; identification, elevation, management of investigator poor performance or non-compliance
- Coordinated all functional groups including Biostatistics, Medical, Finance, Legal, Data Management, Clinical Drug Supply and Regulatory
- Reviewed Site Contracts, Investigator Payments
Project Manager, Clinical Operations
Osiris Therapeutics, Inc.
09.2008 - 01.2012
- Project Manager for a multi-center expanded access clinical trial using human mesenchymal stem cells to treat pediatric patients with steroid refractory acute GvHD under FDA approved IND (1st stem cell biologic approved by Health Canada in 2013, Prochymal); 50 clinical centers in US, Canada, New Zealand, Australia, and Europe; n>100 patients)
- Managed the completion of clinical study enrollment, finalization of SAP, locking of database, production of TFLs, and closure of clinical sites for two Phase III GVHD studies; Transitioned to management of pediatric expanded access study
- Responsible for eligibility, enrollment, and tracking patient progress for participating clinical sites
- Monitored CRF data and cellular laboratory data (both onsite and remotely)
- Managed and negotiated trial budget, change orders and tracking of all clinical invoices
- Worked closely with data management and BIOS team at the CRO for data entry and production of efficacy and safety outputs (primary reviewer of database after data entry)
- Oversight of safety reporting in coordination with CRO pharmacovigilance team, as well as finalization of safety narratives with medical writers
- Creation of documents to support regulatory filings (US, Canada, and Europe), including to author Clinical Study Report, Summary of Safety, and Summary of Efficacy for NDS submission to Health Canada
- Working knowledge of GCP/ICH guidelines
- Worked with legal counsel at Osiris to finalize site contracts
- Authored and amended protocols and supportive study documentation
- Oversaw shipment of product to clinical sites
- Creation and implementation of new CRF pages as necessary and management of study files and clinical documents
- Primary contact for infusion or safety questions, as well as sponsor communication with site IRBs
- Analyzed data for company efficacy and safety updates, IRB annual reviews, and for updates to regulatory authorities; updating Clinical Study Report
- Worked closely with Biostatistical team for production of TFLs within aggressive timeline
- Analyzed data for efficacy and safety presentations for internal company use, physician education, and conference presentations
- Created Mesenchymal Stem Cell Technology and Mechanism of Action presentations for Osiris clinical trials including Crohn’s Disease, Acute MI, and Diabetes
- Participated in enrollment activities and investigator meetings for trials in Crohn’s disease and acute MI
- Continued to provide clinical and scientific representation at conferences in US, Canada, and Europe
- Management activities for expanded access pediatric study (activating sites, enrollment, monitoring, maintaining clinical files, and data entry)
Education
Master of Science - Biotechnology
Johns Hopkins University
Baltimore, Maryland01.2008
Bachelor of Science - Neuroscience
Lafayette College
Easton, Pennsylvania01.2005
Skills
- Strategic leadership
- Policies and procedures
- Clinical Operational excellence
- KPI tracking
- Areas of expertise:
Specific Projects: VOWST (clinical trial execution through BLA approval); Vasfeo (clinical trial execution); ,ADCETRIS® (clinical trial execution); Remestemcel (clinical trial execution while at Osiris)
Publications
Available upon request
Timeline
Senior Vice President, Clinical Development
Seres Therapeutics, Inc
02.2023 - Current
Vice President, Clinical Operations and Data Management
Seres Therapeutics, Inc
06.2018 - 02.2023
Senior Director, Clinical Operations
Akebia Therapeutics
01.2017 - 05.2018
Senior Director, Clinical Program Management
Acetylon Pharmaceuticals
03.2016 - 12.2016
Director, Clinical Program Management
Acetylon Pharmaceuticals
06.2015 - 03.2016
Lead Clinical Research Manager
Takeda Pharmaceuticals International Co.
06.2014 - 02.2015
Senior Clinical Research Manager
Takeda Pharmaceuticals International Co.
09.2013 - 05.2014
Clinical Research Manager
Millennium, the Takeda Oncology Company
02.2012 - 08.2013
Project Manager, Clinical Operations
Osiris Therapeutics, Inc.
09.2008 - 01.2012
Bachelor of Science - Neuroscience
Lafayette College
Master of Science - Biotechnology
Johns Hopkins University
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