Kenneth Harvey Email & Phone Number

San Francisco Bay Area

Clin Ops Dept Head, providing strategic leadership for planning and execution of clinical trial activities.

Redwood City, Ca, Us

o Clin Ops Program Lead for Severe Compromised Immune Disorders (SCID) Programo Clin Ops program Lead for Investigator Sponsored Trials (ISTs) Programo Clin Ops Program Lead for External Research (corporate) Collaborations (ERCs)o Program leadership, strategic guidance and operational responsibility for multiple programs and all associated corporate goalso Overall responsibility for study execution, vendor selection / management, budget and financeo Put in place numerous infrastructure / process improvements, study gap analyses and risk mitigation measureso Works with cross-functional teams and coordinates and facilitates as needed to accomplish study objectiveso Site startup and ongoing coordination with investigators and sites, including maintaining PI relationshipso Facilitated drug release and all relevant site-level regulatory documentationso Safety DB creation, coordination, SAE reconciliationo Full vendor management responsibility for programs including vendor selection, oversight and maintaining business relationshipo Review and input into all contract negotiations and finalizationo Provides Clin Ops leadership and support for external corporate collaborationso Facilitated Safety DB creation, modification and coordination, SAE reconciliationo Facilitated key improvements in Safety processes, strategy, documentation and change managemento Generally works directly with functional leads on the Jasper team to collaborate on key tasks like IP planning, manufacturing/demand planning, drug safety, data management, key document development, strategic planning, etc.o General departmental responsibilitieso SOP developmento Clin Ops Dashboardo Resource planningo Selection, hiring, onboarding and mentoring of new staff

South San Francisco, California, Us

o Molecule/Ops Lead for Phase 1 Oncology Program and helped build Oncology Therapeutic area from scratcho Program Ops Lead Lead for Phase 1b/2 Study in Lupus Nephritiso Helped grow key functions like Safety, and Data Management in a small, rapidly growing companyo People management/development and departmental responsibilities. o Vendor Management: Selection, Bid defense, contract negotiations, onboarding, management, budget, issue resolution, invoicing, and maintaining business relationship.o Overall study budget responsibilityo Site startup: CDA, Questionnaire, selection, budget, CTA negotiations, issue resolution, pre-study visits (PSV), Site Initiation Visits (SIV), etc.o Contributed to Key publicationso Abstract and poster authorship, poster presenter at conferenceso Hiring and mentorship of junior team members, yearly performance reviewso Program leadership, strategic guidance and operational responsibility for two molecules and responsibility for all associated corporate goalso Provided Sr. Management updateso Managed protocol and ICF revisionso HR: Hiring and screening of candidateso Left position for career development opportunities

South San Francisco, California, Us

o Senior Consultant working on multiple rare disease/autoimmune, early stage, clinical programs.o Interdisciplinary team leadershipo Vendor Management/Oversight: CRO, EDC, Central Lab, IRT/IWRS, CMC, etc.o Global Study Startup: AsiaPac, North America, Central/South Americao Document creation/QC: Study Plans (Monitoring Plan, Risk Man, IMP Handling, Safety Plan, etc.), Site Level docs (ICF, role and accountability forms, study binders, manuals, etc.)o Financial responsibilities: invoice review/approval, budget reconciliationo Triaging issues around IMP packaging, labeling, importation, supply/resupplyo eCRF, IRT/IVRS/IWRS QC and User Acceptance Testingo Cold supply chain strategy and chain of custodyo Other misc tasks in support of the Senior Director (please inquire for additional specifics)o Participation in safety and data monitoring committees

Dublin, 2, Ie

o AD Level, Senior Consultant working in Clinical Operation group on a rare disease program in Amyloidosiso Responsible for US and Australian regions for a an Open Label Extension Study as well as other initiatives and support throughout the program. o Vendor management, process plan authorship, general CRO oversighto Site startup and closeouto Drug release and QC of site documentso Data review o TMF Reviewo Invoice review, approval, reconciliation and budget oversiteo Finalization of various clinical planso Working with counterparts in EU and Oceaniao Creation and maintenance of key study metrics

Clinic Director, responsible for all of ALCMI's Operational activitieso Budget projections, accrualso CRO Selection/RFP process, contract negotiations and onboarding of selected vendorso Trained in IND submission by Barnetto Logistical and operational coordination with sites and investigatorso Protocol development for ALCMI-sponsored trials, Investigator-Inititiated Trials (IIT/IST), and even Patient Initiated Trialso Enrollment modelling and resource planningo Site selection and PI/KOL relationship managemento Representing ALCMI at conferences, meetings and external communications and some Business Developmento Worked closely with top Legal firm to revise and negotiate vendor, partner and site contractso Communicating key metrics and updates to the ALCMI Board Members and key stakeholderso Attendance and some presenting responsibilities during ALCMI Board Meetings

San Francisco, Ca, Us

o AD Level Senior Consultant providing drug development expertise and support in clinical and pre-clinical operations for several programs studying gene therapy / gene vectoring in several rare genetic disorders with unmet needs. Largely pediatric population.Operational Lead for two Key programs: Myotubular Myopathy; Crigler-Najjar Syndromeo Led Crigler-Najjar program and supported several other programso Manage interdisciplinary team and overall responsibility for decision-making and study conducto Drive protocol development for Crigler-Najjar Syndrome trial as well as other clinical and non-clinical studies o ICF template development and approvalo CRO/vendor RFP Process, oversight and managemento Development of study and site level documents o Sample handling coordination and central/specialty lab oversighto Project timelines and budgeto Facilitating clinical QA validation of vendorso Oversee data transfer specification process with lab vendorso Worked with KOLs on study design, , endpoints and estimandso Led process for creation of new clinical assessments to serve as study endpoint for ultra rare diseaseo Facilitated key relationship building with the Clinical for Special Children and key developers of specialized therapeutic equipment needed for the Crigler-Najjar programo Set up of WHODrug and MedRA Dictionarieso Clin-Ops point of contact with Central IRBso Set up online cloud vault for study team and siteso In last three months, revamped non-clinical processes and fixed major supply chain issues with lab samples and materials

South San Francisco, Ca, Us

Study Execution Team Leader / Study Manager for multiple global oncology trials. *Entire company shut down by Amgen 31DEC2015*-Operational Lead for Post Marketing Request studies required by FDA and subject to review of data outcome with bearing on the approval of lead molecule (Kyprolis)o CRO and vendor oversighto Turned study around in terms of compliance of paper-TMF, and under-performing CROo PK process managemento Ensure data integrity and all data deliverables are achievedo Ensured all data was ready, on-time, for crucial filing for Kyprolis franchiseo Direct report management (first line): of Sr. CRAs and CTAso Participated and helped facilitate clinical data reviewo ICF/IB change control management and oversighto CSR creation and adjudicationo Inspection readiness and audit preparationo Paper Trial Master File (TMF) inspection and corrective actions - assembled and led team.o Monitoring report review and co-monitoringo Protocol amendment development and adjudication

London, Gb

Sr. Clinical Program Manager Consultant (6 mo contract) at Stem Cells, Inc., In charge of an early phase program for HuCNS-SC® cells (purified human neural stem cells), as a Treatment for Cervical Spinal Cord Injury. o Operational lead for phase II clinical trial and maintenance of phase I studyo Hit the ground running to fill critical gap until FTE resources could be brought in-house o ICF template development and ICF negotiations with sites as well as working with in-house legal counsel as needed o CRO and vendor oversighto IRB Submissions for both central IRB and local / institutional IRBso Oversight of all site startup activities o Regulatory strategy o Site management and training o Clinical data review o Development of all study documents and site binder o Vendor management o Sample handling coordination, central lab oversight, and creations of lab manual o Project timelineso Investigational product distribution and coordination with manufacturing o Full budget and finance responsibilities for overall trial as well as developing site budget templates and negotiation individual site budgets

Hanover, Maryland, Us

Clinical Trials Manager Consultant placed at Cytokinetics, working on global early phase trials in ALS, and cardiology. 6 month contract initially, but stayed longer to finish key tasks.o Operational lead for phase I clinical trial and support for global phase II trial in ALSo Protocol development for several first in human (FIH) studieso Worked closely with Stats Programmer and Data Manager to develop in-house system to track down and account for ~10,000 samples with 99.4% accuracyo Key input into regulatory strategyo Led key site management and trainingo Conducted SIVso Clinical data reviewo Safety Opso Develop study documentso Vendor managemento Sample handling coordinationo Project timelineso Budget and finance

South San Francisco, California, Us

Clinical Trial Manager Consultant at Genentech, Inc. Working on global early phase trials in Alzheimer's, Oncology, and Virology.-Operational lead for global phase I and II clinical trials-Protocol development and strategy-Regulatory -Site selection and training-IXRS spec, rand design, setup, testing-Vendor management-Supply chain setup/management -Project timelines-Investigator meeting planning and execution-Budget and finance

Troy, Michigan, Us

Clinical Trial Manager Consultant at Genentech, Inc. Working on global early phase oncology trials. Converted to FTE.-Regions: North America, EU, Asia Pac/Oceania, Latin America. -Regional ICF development-Regulatory support and strategy-IXRS setup/UAT-Vendor management-Supply chain setup/management-Project timelines-Investigator meeting: training and presentations

Deerfield, Illinois, Us

Managed global clinical trials for Baxter BioScience. -Early phase study for BAX 326 recombinant factor IX in severe to moderately sever patients with Hemophilia type B.-US, Japan and Latin America regions.-Responsible for creation and monitoring of study time lines and deliverables.-CRO and vendor selection and management.-Ensures quality of data and study execution in accordance with study protocol, GCP, SOPs, Declaration of Helsinki, ICH and regional regulatory guidance.-Coordinate with EU headquarters in Vienna and regional partners in Japan and Latin America.-Provide metrics and study progress updates to senior management.-Overall budget responsibility and updates to corporate finance.-Participate in corporate initiative in the areas of process improvement and clinical technology development.

Training and consultation for BioPharma, Banking, Insurance, Non-profit, High Tech, and other industries. Clients include: IBM, Thomson Reuters, Generali, AX Pharma, L'Equipe, TF1, La HALDE, Metaboli, etc. Mostly focused on areas of communications training, marketing and sales.

South San Francisco, California, Us

Clinical Trial Management for phase I-IV trials in Pulmonary, Neuro and Oncology indications.-Global Lead Clinical Trial Manager for 3-5 trials simultaneously.-Involved in entire process from Protocol Development through database lock and filing. -Worked on a crucial filing for a liquid formulation of Xolair and on my own initiative designed many crucial solutions in the areas of cold supply chain, drug resupply and depot procedure that made sure that FDA obligations were being met for the eventual filing. -Budget review and payment approval responsibility for sites and vendors.-CRO/Vendor selection, management and training. Drafted Project Management and Monitoring Plans-Extensive IVRS experience including leading numerous project execution teams, drafting/approval of IVRS Spec and User Acceptance Testing (UAT).

Craigavon, County Armagh, Gb

Project Lead for development of Interactive Voice Response Systems (IVRS) for top Pharma and Biotech clients in the US and Europe. Left position to pursue ultimate goal of Clinical Trial Management at the sponsor level at Genentech.-Became an expert on Subject Randomization for Clinical Trials. Created numerous specs for team Biostatisticians to create code based randomization schemes.-Direct Point of contact for major Biopharma clients like Medicines Company, Roche, Amgen, etc.-Designed numerous supply chain strategies from depot, to sub-depot to site. Includes consultation with clients on kit design, labeling and drafting procedural documents. Also managed the day-to-day operations of these systems.-Managed the software development team and held ultimate responsibility for timely completion and overall quality of the project.

Us

Project Management of Cardiovascular Core LabServices and some full service CRO services:-Global project phases I-IV-Extensive shipping experience, including creating policy and procedures/SOP and and building the inventory management database.-Key experience learning the business process of numerous Biopharma clients like Genzyme, BMS, Genentech, Merck, etc.

Coordinating pharmaceutical research trials for the San Francisco Headache Clinic, San Francisco Dementia/Alzheimer’s Clinic under the direction of Jerome Goldstein M.D. Left with Physician’s blessing to pursue career in Research Management at the vendor level.-Became a subject matter expert in Migraine therapies.-Performed EKGs, venipuncture, drug accountability and all lab preparation.-Did all my own site regulatory (i.e. 1572, CLIA certificates, local and central IRB, etc.)-Point of contact for query resolution, source document verification and regular monitoring visits.-Also help generate business for the clinic by contacting BioPharma companies and creating a sales database.

Us

Helped manage Marketing, PR and Communications for a Silicon Valley Software Company. Also worked directly with CEO and Chairmen of the board on Investor Relations and was instrumental in rewriting key sections of the company's business plan that then garnered a successful round of funding.

International Executive Mba, International Business

Ba, English/Creative Writing