George A. Omburo, PHD

*** ******* **

Jersey City, NJ 07305

201-***-****

ad41tr@r.postjobfree.com

Professional Summary:

Results-driven Clinical program manager with over 24 years of experience in managing and executing clinical programs across various therapeutic areas including oncology, rare diseases, Infectious diseases, neurology, hematology, dermatology, Metabolic (diabetes) and cardiovascular diseases.

Skilled in leading cross-functional product development programs and Clinical trial team management, specifically developing and implementing strategic product development plans, and ensuring compliance with FDA regulations and ICH guidelines.

Proven track record of delivering successful clinical programs on time and within budget while maintaining high-quality standards.

Strong communicator with excellent leadership and problem-solving skills, able to build and maintain relationships with internal and external stakeholders.

Former college assistant professor with bench research and teaching experience, useful in mentoring/training junior colleagues.

Professional Skills:

Clinical research program management and Operations

Team management

Strategic program planning

Health Authorities (HA) Interaction

Regulatory compliance, RIM, and Reg CMC

Program Budgeting and financial management

Drug Safety/Pharmacovigilance/ Risk management.

Communication and collaboration

Data analysis and interpretation

Quality assurance

Core Competencies:

Led and directed strategic program planning and execution of clinical development programs for multiple compounds across various therapeutic areas, including rare diseases, cardiovascular, hematology, metabolic (diabetes), neurology, oncology etc. Developed and implemented life-cycle strategies, clinical development plans, and product development plans.

Managed clinical trial execution from initiation to close-out according to project timelines and budgets.

Coordinated and led cross-functional teams, including clinical sub-teams and vendors, to ensure successful planning, execution, and completion of all phases of development activities.

Led and managed clinical study teams, ensuring adherence to GCP/ICH and regulatory requirements.

Supervised and trained clinical research associates (CRAs) and other team members.

Developed and maintained productive working relationships with internal and external stakeholders.

Ensured study execution compliance with GCP/ICH and other regulatory requirements. Worked cooperatively with Quality Assurance with respect to site audits.

Authored regulatory submissions, IND, EOP2, and Scientific Advice (EMA) briefing packages.

Planned and participated in Mock Audits as part of Inspection Readiness Plan (IRP)

Managed the Regulatory submissions (RIM), CMC activities for aclerastide manufacturing (cGMP) including Project Planning, Project Execution and Control

Established effective operational procedure (SOPs) and changed documentation process, and communication with team members.

Developed program and individual study budgets, oversaw overall program budget, and supervised budget approvals, review of latest estimates, and resource planning for the program.

Managed vendor and CRO activities and tracked internal and external (CRO/vendor) project deliverable to ensure they remain within the timeline and budget.

Participated in the vendor selection process, including input and review of the draft RFP, review of returned RFPs, bid defense meetings, audits, and final vendor selection.

Education:

BSc Hons, University of Nairobi.

MS, University of Maine

Ph.D. Biological Chemistry, Texas A&M University, College Station, TX 1992

Professional Experience:

Eccogene Inc. Aug 2023 – Mar 2024

Consultant, Clinical Development Operations

Clinical Development operations consultant for Eccogene early clinical program responsible and accountable for:

Clinical Development Operation and Management for two early Metabolic Diseases Clinical programs at Eccogene.

Non-peptide GLP-1R Agonist (ECC5004) and b) Liver-Targeting THRβ Agonist (ECC4703)

Author of standard operation procedures (SOPS) for clinical operations department, Pharmacovigilance, and regulatory operations

Responsible for leading vendor evaluation and selection process including generation of Request for Information (RFI) if new vendors need to be identified.

Provides strategic leadership to clinical development and operations team in the review, approval, and implementation process for clinical development documents (CDP) and operations procedures (SOPs), Manuals, and operations guidance or working practices.

Responsible for Vendor Bid process, for any CRO services requested by Clinical Team. Selects vendors in connection with the outsourcing of clinical-related services.

Ensure active and on-going communication of operational issues between vendors.

Contributes to protocol development; Reviews Protocol Drafts DDI, BA, FE etc.

Assist the VP with Reviews and analysis of study data output as assigned.

Otsuka Pharmaceutical, Princeton, NJ Jul 2021 – Jun 2023

Sr. Consultant, Clinical Management

Oversight of post apprConsultant, ent study of brexpiprazole major depressive disorder (MDD) and alzheimer's post approval clinical studies and the Phase I/II studies of TB program.

Provides strategic leadership to the clinical operations team, managers, associates and CTLs on post-approval commitment study for Otsuka Global Medical Affairs

Leading the timeline, budget and key milestone setup meeting and tracking of deliverable by the team

Working with MW team to author and review, protocols, SOPs, IBs, Manuals and IND annual updates (DSUR) including clinical study entries (clinical trial information and results) to Clinicaltrials.gov

Lead vendor evaluation and selection, request for proposal (RFP), including presenting top choices to management and justification for and providing selection recommendation.

Manage clinical outsourcing activities; vendor oversight, contracts, performance, and budgets including change orders and all components associated with clinical study programs.

Leading management of the operational aspects of study start up, site contracting/activation, medical monitoring, drug safety (pharmacovigilance), data management, DBL, Study/site closures, for Global Medical affairs.

Performed Data review, DBL, study close.

Provides direction and strategy related to site Identification, site selection and patient recruitment efforts and activities to deliver on enrollment milestone for MDD and Alzheimer's Brexpiprazole post approval commitment study and the TB program.

Provides regular updates to management team and provides solutions as needed to program risks and barriers.

Ovid Therapeutics, New York City Jul 2020 – Jun 2021

Director, Clinical Development Operations (consultant)

Leading Ov101 clinical matrix team and ensuring that study objectives fulfill Regulatory and reporting requirements and support medical governance.

Responsible for design and execution in collaboration Medical Monitor/physician for multiple-phase I/II and III studies on Angelman’s disease (CNS).

Engaging and influencing diverse scientific community of Ovid internal and external neurology experts.

Ensuring delivery of quality study strategy and design, understand the analysis and interpretation of clinical and safety data for OV101 Studies.

Project accountability, training and mentoring other team members within clinical operations development.

Appropriately interact with Key External Experts (KEEs), Key Opinion Leaders (KOLs), collaborators, advisory boards, etc. in the development of CDP, protocol, and scientific opinions on Angelman’s disease

Leading or contributing to protocol concept sheet (PCS), protocol and to final study report (CSR) delivery of clinical activities consistent with the clinical development strategy for regulatory approvals, reimbursable medicine, and successful life-cycle management.

Ensuring high quality study documents are developed (in alignment to the CDP) to effectively determine Ovi101’s potential efficacy, safety profile, key areas of product differentiation and value to Angelman’s patient.

Driving/contributing to clinical components of the IB or its amendment, and documents for regulatory submissions and advisory requirement, including scientific advice, IND, EoP2, pre- NDA meetings, NDA, and other submission document.

Endo Pharmaceuticals, Inc., Malvern, PA Dec 2017 – Jun 2020

Associate Director, Clinical Development Operations

Clinical development lead (CDL) for Early and Late phases (Phase I/II and Phase III) of two projects, and assist in the planning, implementation, managing, and reporting of clinical trials.

Responsible and accountable for execution of clinical studies in assigned project(s).

Ensuring clinical studies assigned are conducted according to GCPs and Endo SOPs and guidance.

Responsible and accountable for the scientific validity and integrity of the Clinical Development Plan (CDP) and all clinical content, including clinical trial synopses and protocols, Investigator Brochures/IDFUs, clinical and safety data reviews (SAPS and TLFs), CSRs, regulatory submissions updates and publications associated with the assigned studies.

Develop expertise in therapeutic area assigned by assisting in conducting literature searches and reviews, meta-analyses, evaluate emerging clinical trial data; assist with data interpretation and data mining and publishing data.

Responsible for selecting and convening, where required; the Independent Data Monitoring Committee (DMC) for review interim data of an ongoing study at a protocol-pre-specified time point.

Convene medical/scientific panels or KOL meetings to seek current expert opinion for inclusion in clinical development plan or study design in the assigned therapeutic area.

Contribute to the preparation of IND/NDA/BLA medical/scientific sections.

Support business development activities by evaluating new product potential.

Authoring and reviewing of clinical study entries (clinical trial information and results) for posting towww.clinicaltrials.gov (clinical trial registry and results database) and/or a TPR (Third Party Registry).

Participate in clinical development activities including Endo’s internal process improvement activities such as SOP authorship, training material development and review.

Mentoring and providing guidance to junior team members.

Strategic development of collagenase clostridium histolyticum (CCH) including project planning and execution of CCH portfolio studies.

Protocol development: Clinical Study design and Trial execution in phases 1-4: Design trials with other functions (biometrics, pharmacovigilance, regulatory etc.); authoring and reviewing clinical documents (e.g., protocols, eCRFs, ICFs, CSRs)

Contribute to the scientific and clinical development plans (CDP) of new compounds or new indication of existing drugs.

Design and execute Animal Histopathology study, MRI imaging study in attempt to understand pre- and post CCH treatment tissue structure by imaging.

Contribute to relevant IND/NDA/BLA medical/scientific sections as requested by Clin-Dev VP.

Key leader and process owner of clinical data review for CSR and eventually for BLA/NDA (Clinical and CMC sections) writing

Identify and seek expert input from key opinion leaders in study design and strategy development.

Interact closely with Clinical Operations Leads and Biometrics Leads to establish operational aspects and statistical endpoints of the clinical studies to assure successful conduct of studies.

Responsible for the clinical oversight, pharmacovigilance, and medical review of clinical trial data in collaboration with the Medial Monitor.

Vendor (CRO) Selection Strategy: Lead role in identification of, selection of and supervision of the “Right CRO for the Endo study”

Conduct the Investigator Meetings, develop scientific and protocol training materials (presentations) to support Investigators Meeting or internal meetings. This presenting of results at Endo completed studies.

Review clinical data with some assistance from DM representative and contribute to the development of clinical study report, e.g., integration of analyses into clinical documents, senior management briefing of preliminary data/report and regulatory submissions.

Manage the processes required to support external study review committees, e.g., independent data monitoring committees, steering committees.

Budget and Resource management: Assess and allocate resources for each program appropriately based on scope of work for each program. Track overall study and program budget for Clinical Development department.

Prepare clinical Development budget and forecast for both short term and long-term clinical activities.

Collaborate with other internal and external stakeholders (imaging vendors, safety, commercial, and regulatory affairs) to ensure efficient translation of the clinical protocol into operational deliverable.

Contribute to the scientific content of program level deliverable, e.g., Investigator Brochure, internal/external presentations, regulatory submissions.

Mallinckrodt Pharma Inc, Hampton, NJ Mar 2016 – Dec 2017

Sr. Consultant; Clinical Development Operations

Therapeutic Area: Rare diseases; Autoimmune Rare Disease (ARD); Systemic Lupus Erythematosus (SLE)

Strategic development lead responsible for protocol/clinical trials design and operational activities for phase I-III program.

Manager of clinical trial execution to completion according to project timelines and budget

Chair clinical sub-team meeting: Coordinates and leads cross-functional teams, such as the clinical sub-teams that include representatives from multiple internal departments (e.g., Medical Science, pharmacovigilance, Regulatory Affairs, and Data Management). Provides regular and timely updates to senior management.

Track and report Metrics: Site activations, enrollments, budget, deviations, amendments etc. SAEs, DCFs, CRF completed, IRB/EC approvals, etc.

Reviews and contributes to protocols, amendments, case report forms (CRFs), and clinical study reports (CSRs)

Develops informed consent documents.

Coordinates the qualification and selection of investigative sites, plans for, and presents at Investigator Meetings, develops other site training materials.

Develops clinical trial timelines, enrollment projections, documents, and instructional materials in support of trial execution, including project, communication, monitoring, recruitment, risk mitigation, and contingency plans.

Partners with the Clinical Services Partnership (CSP) in identifying appropriate vendors for possible selection. Participates in the vendor selection process, including input and review of the draft RFP, review of returned RFPs, bid defense meetings, audits, and final vendor selection.

Manages vendor and CRO activities and tracks internal and external (CRO/vendor) project deliverable to ensure they remain within the timeline and budget.

Responsible for ensuring the development and updating of cost estimates at the study and project level.

Partners with the Clinical Services Partnership (CSP) team in developing complete clinical trial external cost estimates (sites and vendors) and maintains responsibility for the management of the clinical trial budget.

Ensures CRAs assigned to a project are trained on the protocol and relevant SOPs, reviews monitoring visit reports, accompanies CRAs on site visits, and initiates/follows up/tracks significant or relevant project issues at investigative sites.

Ensures study execution in compliance with GCP/ ICH and any other regulatory requirements and works cooperatively with Quality Assurance with respect to site audits.

Develops trial monitoring plans and tracks and reports compliance and risk management.

Partners with the Clinical Trial Associates to ensure the eTMF is developed, maintained and QC’ed and archived.

Stays current with regulations and industry trends and provides input into processes to ensure adherence to regulations and meet best practice standards.

Communicates project issues and identifies emerging risks, then works with internal governance team of director-level (and above) multidisciplinary drug development professionals to help resolve project challenges.

Derma Sciences, Inc. Princeton, NJ Feb 2012 – Jan 2016

Team Leader, Early and Late Phase Clinical Development

Team leader responsible for all Clinical development plans and CMC development strategies and activities of DSC127 (ACLERASTIDE), an angiotensin II peptide analog currently in phase III for re-epithelialization in diabetic patients suffering from neuropathic/neurological ischemic ulcers and in Phase I for radiation dermatitis of oncology patients.

Responsible and accountable for execution of Clinical studies and CMC deliverable to senior management

Developed Strategic development plan (life-cycle strategy) that was approved by upper management for ACLERASTIDE in oncology-radiation dermatitis.

Formed and lead the integrated project teams for Diabetic Foot Ulcer (DFU) and Radiation dermatitis to ensure successful planning, execution, and completion of all phases of development activities leading to successful registration and launch of the angiotensin analog in diabetic ulcer and RD indications.

Working with team of experts; designed and authored Clinical Development Plan (CDP), and product development plan (PDP) including clinical, toxicology, and clin-pharm study protocols.

Lead the program team in authoring regulatory submissions, IND, EOP2 and Scientific Advice (EMA) briefing packages, annual updates.

Selected Clinical CRO, DM CRO, CMO (CMC activities), and Drug packaging and supplies management, Central and Imaging labs for the programs.

Selected subject recruitment agency to augment enrollment efforts of the main CRO and to ensure timely completion of the study.

Supervised several clinical study teams to conduct and monitor data according to GCP for Phase III DFU programs and early development protocols (phase 0-I) for oncology radiation dermatitis.

Lead clinical, medical and safety monitoring of DSC127 program including pharmacovigilance and safety risk assessment.

Lead the clinical outsourcing activities; vendor selection and vendor management/over-site and vendor budget control.

Lead the Regulatory communications materials, RIMs, preparation of NDA CTD modules in readiness for NDA submission.

Planned and participated in MOCK AUDIT as part of Inspection Readiness Plan (IRP)

Lead team in developing generic name and brand name of new compounds.

Additional Indication Evaluation: As part of Life Cycle Management Strategy, I lead Clinical and Formulation consultants in developing company briefing paper ACLERASTIDE re- epithelialization potential in surgical wound healing which was approved for implementation contingent on successful DFU data.

Establish R&D SOPs, SOPs for Clinical, Data Management and CMC development activities.

The phase III program was terminated in December by Derma Sciences management following interim analysis at half-way (50%) completion data, showing that ACLERASTIDE on a large population, is only marginally efficacious.

Eisai Pharmaceuticals, Oncology Product Creation Unit, Woodcliff Lake, NJ Oct 2008 – Dec 2011

Senior Director, Clinical Development, Program Management

The Operations Manager of International Project Team (IPT) Core team drug development for the clinical oncology global team with specific role of leading 2 early compounds out of Eisai Japan Laboratory facility into first-in-human studies. Leading compound teams, each consisting of over six study sub-teams composed of different functions, study director, study manager/scientist, biostat, pharmacovigilance, US/EU/JP regulatory rep, data manager, supplies, demand innovation and other study support staff.

Phase I-III studies of tyrosine kinase inhibitors (TKI) and anti-microtubuline growth compound on targeted solid tumors (oncology) of lung NSCLC, kidney, thyroid, melanoma

Guide the team in writing protocol concept sheet (PCS) and present the PCS to company review/advisory board (CRAB) and defending the protocol at Protocol review committee (PRC) meetings and negotiating key sticky issues for revisions on behalf of the team.

Convenes KOL meetings and DMC and seek their input on study design or development proposals.

Set key performance indicators (KPI) with the team and ensure the team achieves the milestones.

In collaboration with commercial team, perform marketing assessment or potential including NPV estimation.

Managing clinical operations team with an annual program budget of $200M.

Manage vendor contract negotiations, patient recruitment agencies their performance review or deliverable.

Train and supervise team members, highly experienced team comprised of 7 direct report study directors and managers/scientists.

Responsible for providing update and communication with senior management via Monthly Oncology Meeting for entire OCN Unit chaired by the ONC unit President on enrollment update for the goal.

Devise methods for enrollment improvement e.g., site training, adverts, and community awareness.

Drug development plan DDP lead author and presenter to the company key milestone review committee CMRC in Japan.

Responsible for been a Partnership Portfolio Manager for Eisai-NovaQuest oncology project max collaboration (a $50M collaboration for clinical milestones of Eisai oncology compounds for solid tumors).

MannKind Corporation, Paramus, NJ Jan 2008 – Aug 2008

Senior Consultant, Clinical Research Operation

Senior consultant for the NDA Submission Task Force for Mannkind inhaled insulin program.

Working with senior company managers (Functional Heads); plan and oversee preparation for the NDA submission.

Chair the steering committee (senior management) meeting on NDA submission issues and the Submission Review Team

Set target delivery dates for the Submissions team’s major activities to meet the submission goal.

Coordinated all NDA submission team activities including Pre-NDA meeting with FDA, CSR, Clinical sections ISS, ISE, and CMC regulatory section for submission.

Coordinated and Reviewed Hypoglycemia and pulmonary function white papers and associated summaries for the submission.

Working with Mannkind senior management in developing a process for Project Management within clinical operation (creating a 3-Member Core Team Leadership).

Daiichi Sankyo Inc and Daiichi Medical Research Inc, Edison NJ Sep 2004 – Dec 2007

Senior Director, Clinical Development, Program Management

Global Project director and leader of the Global Integrated Project Team (IPT) comprised of colleagues from Japan, EU, and USA.

Provides Global leadership for all strategic planning and execution of pharmaceutical target from preclinical stage to regulatory submission with the following responsibilities.

Working in collaboration with IPT members and line research organization, develop and implement strategies for development of DZ-697b, a novel antiplatelet agent and CS-8663 an antihypertension drug combination.

Responsible for the evaluation for go/no go and transitioning new compounds from Preclinical Stage to Clinical Development

Responsible for Early development of new chemical compounds including the development of global target product profile (GTPP), proof of concept (POC), Forward Development planning (FDP), contingency planning (alternate approach to point of decision) and clinical development plan (CDP) and emerging product profile evaluation.

Responsible for leading the global Integrated Project Team (IPT) members both direct and non- direct reports in cross-functional disciplines (Clinical, Commercial, Nonclinical, Regulatory, Manufacturing/CMC etc.) drawn globally from Japan, EU, and US

Directed the planning and execution of the successful IND and NDA (e-CTD) submission (antihypertension combination drug, filed November 2006) by Daiichi-Sankyo Inc.)

Working with the team, performed Emerging Product Profile (EPP) mapping with Target PP for team go/no go recommendation and for company executive committee for portfolio prioritization.

Identified key potential program go/no go elements and strategies and addressed them with senior management.

Additionally, managed the TZT dolastatin and dodetaxel oncology program.

Performed due diligence assessment of DMR dolastatin TZT program (anti solid tumor compound) oncology project and provided go/no-go recommendation for the compound.

Developed CDP for dodetaxel compound.

Organizing quarterly Global team meeting in Japan and USA program review to map emerging data with company objective, goals, and priority.

Coordinates and/or prepares key IPT deliverable including senior management presentations and reports, Target Product Profile (TPP), Forward Development Profile (FDP), Clinical Development Plan (CDP), Monthly Project update summaries (MPS), tracking reports, project timelines, budget, resource allocation.

In collaboration with line functions, develop and oversee integrated cross-functional budgets ($145M) and resource requirements for IPT programs.

Organizes key opinion leaders KOLs meetings/consultation formally and informally for the development of proof of concept (POC), clinical development plan (CDP) and alternative scenarios for stroke and cardiovascular target.

Provides training and mentoring to other team members and staff to maximize their potential in the Global team.

Purdue Pharmaceutical L.P. Medical Research Department, Stamford, CT Aug 2000 – Sep 2004

Senior Clinical Development Research Scientist

Scientific and study leader of Phase II-III clinical studies in osteoarthritis, neuropathic, diabetic, and surgical and cancer pain models.

Clinical operations; designing studies, developing/implementing clinical research protocols, overall responsible for successful execution of clinical studies including routine monitoring, SAE reporting etc.

Continuous review of clinical data collection either in CRFs or in databases.

Working with medical writers and biostatistician to write CSR and other manuscripts for IND/NDA submissions.

Develop drug specific strategic development plan (CDP), training programs for internal and external staff in clinical and marketing departments.

Responsible for the management of the program budgets ($50M), contracts and study timelines/milestones.

Ensured that clinical studies (Hydromorphone HCl, Hydrocodone, Buprenorphine Transdermal Delivery System and Oxycodone), are conducted according to ICH, GCP and Medical Research department SOPs.

Conduct study specific training of team members.

Attending internal and external scientific meetings and management training seminars.

Schering-Plough Research Institute Anti-Infective Department, Kenilworth, NJ Jul 1998 – Aug 2000

Project Manager

Serving as lead clinical operations manager for the antifungal global project; conducting studies on allogeneic bone marrow transplant (oncology) patients for both USA and International sites

Key responsibility includes Design and write anti-fungal phase III protocols, organize, and give protocol presentations at investigators meetings.

Prepare regulatory document for IND/NDA submission.

Setting-up new studies including Project goals and timeline setting, budget, study investigator selection, coordinate

Supervise field CRA activities, protocol compliance, and attends to both international site questions.

Responsible for training new team members.

Chairs study team meeting in the absence of the clinical team leader.

National Hemophilia Foundation, Department of Clinical Research, New York, NY Jan 1997 – Jun 1998

Director of Clinical Research

Directing all aspects hematology studies related to AIDS (HIV) clinical trials including protocol development, study conduct, data reporting in hemophilia population.

Lead team in evaluating Gene therapy for treatment of hemophilia (Gene Therapy for Hemophilia Initiative (GTHI)) including QoL impact, risk/benefit assessment and potential impact.

Lead contact for Hemophilia Foundation with NIH, FDA, and pharmaceutical companies on Gene therapy Initiative.

Director of the Medical and Scientific Advisory Council (MASAC).

Establishing AIDS clinical studies with new therapeutic agents on hemophiliacs.

Clinical data management, Supervising MRAs, CRAs and data managers.

Organizing Medical and Scientific conferences and workshops e.g., Hepatitis conference in Philadelphia: Inhibitors of Hemophilia Conference in Orlando Fl: Gene Therapy for Hemophilia Workshop in San Diego.

Business Development, working with the CEO and Director for Government relation to maintain; research funding (NIH) and blood safety by the blood safety advisory board of the FDA.

Directing activities of professional working groups; Nursing, Social Work and Physical Therapy working groups.

Thrombosis Research Center, Temple University School of Medicine, Philadelphia, PA Dec 1992 – Jun 1998

Assistant Professor and Postdoctoral Fellowship

Assistant Research Professor

Conduct independent Preclinical/laboratory research on PDE3 and PDE4 found in the heart, blood (Platelet and Monocyte) and cancer cells including their possible role in APOPTOSIS.

(Programmed Cell Death-oncology).

Teaching Graduate and Medical Students.

Chair of Departmental Seminars.

Faculty Representative to Environmental Health and Radiation Safety Committee.

Postdoctoral Fellow: Thrombosis.

Completed postdoctoral research under the leadership of Dr. Robert Coleman, Chief and Head of Thrombosis Research Center. Research on hematologic role of PDEs.

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