SUKIE SHOPEJU, MD
Houston,Texas
Summary
Experienced Clinician with extensive and proven track record in Clinical research/trial management across multiple studies and in various therapeutic areas from Phase I, II, III and IV. Strong professional background in Medicine. Proficient in Drug Development/Medical Monitoring, Study Start-up, Budget Management, Data Management and Regulatory Compliance. In-depth knowledge of analysis and interpretation of Clinical Data, Safety/Pharmacovigilance standards, FDA, ICH /GCP regulations and submissions. Excellent communication/interpersonal Skill, Audit preparation and response, organizational/problem-solving skills and mentoring.
Overview
14
14
years of professional experience
Work History
Medical Director, Clinical Development
Prothena Biosciences Inc
San Francisco, CA
02.2022 - Current
- Serve as scientific subject matter expert and primary medical contact to internal and external stakeholders including KOLs, Investigators and clinical sites
- R n D strategy lead in clinical trial design and endpoint development
- Lead the medical monitoring team in performing medical monitoring activities, including review of subject eligibility, safety profiles, data listings, Coding, SAE reports, ECGs/Central lab reports/critical values
- Collaborate with translational and pharmacology team on selection of biomarkers
- Identify data risks, trends/outliers to clinical activities and assist in developing plans to mitigate risks
- Collaborate with data management team on EDC build, CRF design/review, query management and review of other study-related documents
- Liaise with medical writing team and clinical operations team to develop key study documents including study synopses, protocols, investigator brochures, protocol deviation plans medical monitoring plan (MMP), safety management plans (SMP), informed consent forms, IND Annual Reports,
- Collaborate with Biometrics to identify key issues, prepare scientific content and facilitate discussions at safety review committee, DSMB meetings or data monitoring committee (DMC)
- Liaise with Pharmacovigilance team to review/revise clinical study report, safety reports including, SAE narratives and analysis of similar events, DSURs and SUSARs reports, risk management plans, integrated summaries of safety and efficacy.
- Reviews and reconciles all protocol deviation classifications in collaboration with clinical operations team and prepare protocol deviation list for CSR.
- Provides clinical specifications to external vendors for alignment with study requirements
- Present study updates and topline results to leadership
- Assist in writing documents to support regulatory submissions; generation of notification letters to investigators, regulators, and IRBs/ECs
- Liaise with Business Development, participate in bid defense meetings and manage evaluation/ selection of investigators and study sites
- Facilitate project-specific and therapeutic training at sites, internal and external Investigator meetings
- Attend/contribute to relevant scientific conferences, seminars, or presentations
- Evaluate spontaneous reports and literature cases
- Participates in Database lock activities such as final listing review, review of blinded tables, listings, and figures (TLFs)
MD/ Lead Clinical Scientist
Syneos Health
Morrisville, NC
09.2020 - 02.2022
- Led the medical monitoring team in performing medical monitoring activities, including review of data listing, coding, SAE reports, ECGs/central lab reports and critical values
- Served as point of contact for scientific issues/questions for internal and external stakeholders including KOLs, Investigators and clinical sites
- Acted as scientific subject matter expert and primary medical contact to study sites for assigned clinical study
- Liaised with medical writing team and clinical operations team to develop clinical research documents, including study synopses, protocols, investigator brochures, clinical study reports, feasibility assessments, protocol deviation plans, pediatric investigation plans, site selection strategies
- Performed periodic review of clinical data, statistical analysis, and interpretation
- Reviewed subject eligibility, safety profiles and scientific integrity of clinical trials
- Prepared/Approved study-related documents; medical monitoring plan (MMP), medical data review plan (MDRP), safety management plans (SMP), informed consent forms
- Participated in clinical trial design and endpoint development
- Collaborated with data management team on EDC build, CRF design/review, and query management and reviewing other study-related documents
- Identified data risks, trends/outliers to clinical activities and assisted in developing plans to mitigate risks
- Prepared/Presented scientific slides at study kick off meetings, Quick Start camps, investigator meetings, safety review committee and DSMB meetings
- Reviewed and reconciled all protocol deviation classifications and prepared protocol deviation list for CSR
- Participated in Database lock activities
- Developed scientific rationale for methods, design and implementation of clinical protocol changes, data collection systems and final reports
- Assisted in writing documents to support regulatory submissions; generation of notification letters to investigators, regulators, and IRBs/ECs
- Collaborated with drug safety department by providing medical input in Periodic Safety Update Reports and interpretation of study data for regulatory submissions
- Liaised with Business Development, participate in bid defense meetings, feasibility studies and conduct presentations to potential clients
- Facilitated project-specific and therapeutic training at investigator meetings/sites, governance committees and external meetings
- Evaluated spontaneous reports and literature cases; communicates detailed outcomes and results of research findings to relevant partners
- Participated in interactions with health authorities.
Clinical Scientist
Syneos Health
Morrisville, NC
09.2019 - 08.2020
- Performed periodic review of clinical data listings, coding, ECGs/Central lab reports and other external data for safety and critical values
- Handling action items and medical communications and document safety assessments within IT systems
- Led study team meetings in partnership with the medical director and other cross functional study team members
- Reviewed/Updated trial budget to align with medically related scope of work
- Performed activities related to data generation and validation including CRF design, query generation /resolution and escalated questions to medical director
- Contributed to safety review committee, Data Monitoring Committee (DMC) or DSMB meetings
- Developed study related documents including medical monitoring plans, medical data review plans and safety plans
- Contributed to development of trial-related documents including clinical trial protocols, investigator brochures, site training materials, charters, standard operating procedures,
- Ensured that team members and site staff are well trained on study protocol and therapeutic indication
- Participated in investigator meetings and bid defense meetings.
Senior Clinical Research Associate
Pharm-Olam International
Houston, TX
05.2016 - 09.2019
- Evaluated clinical trial resourcing requirements for qualification, training, monitoring, and support of sites during conduct of trials
- Performed site evaluation visits, site initiation visits, interim monitoring visits and close out visits at several investigator sites
- Reviewed Case report forms (CRFs) following the ALCOAC principles and GDP; ensuring all source data/documents & other trial records are accurate, complete & maintained throughout the clinical trial
- Supports subject/patient recruitment, retention and awareness strategies
- Documented activities via confirmation letters, follow-up letters, trip reports, Communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan
- Performed investigational product (IP) inventory, reconciliation, review of storage and security
- Reviewed Investigator site files for completeness and accuracy; ensure all study date Reconcile contents of ISF with Trial Master File (TMF)
- Provided guidance at site/project level towards audit readiness standards and supported audit preparation and required follow-up actions
- Participated in Bid defense meetings and study startups Presentation at investigators meeting
- Performed PI/Investigative site selection and site training at investigator sites
- Developed study documents such as monitoring plan, source data verification plan, laboratory manual, annotated reports
- Oversaw setup of trial sites; ensuring each site has appropriate trial materials to conduct study
- Periodically reviewed data to identify potential issues or inconsistencies that could signal problems with data collection or monitoring
- Developed and executed plans to close trial sites on completion of trials and perform associated close-out activities
- Assist with development of study related documents such as protocol, CRF development, informed consent template, pharmacy manual, Subject diaries etc.
Clinical Research Associate
GlaxoSmithKline
Research Triangle Park, NC
02.2015 - 04.2016
- Involved in start-up process including reviewing protocols, reviewing CRFs, preparing informed consent forms, developing study documents, organizing, and presenting at investigator meetings
- Prepared site evaluation and site initiation checklists, protocol synopsis and training slides conduct site evaluation visits, site initiation visits, monitoring visits and close out visits at assigned Investigators sites
- Ensured all study staff are qualified, trained and delegated for duties performed on delegation of duty log
- Trained investigators, study coordinators and other study staff on study protocol, Investigator’s brochure, Lab, and Investigational medical product requirements
- Built study templates for Subject enrollment, questionnaires, Investigational medicine logs and Inform consent forms
- Ensured timely submission of contract and study documents to IRB/IEC for approvals
- Ensured all AEs/SAEs are well-documented and reported to sponsor and appropriate authority per IRB/IEC guidelines
- Work with CTL in managing study contract/budget, invoicing and payment process for all clinical trial vendors including investigative sites
- Communicates deviations/violations from the protocol, SOPs, GCP & the applicable regulatory requirements to the Investigator for follow-up actions
- Ensured sites conduct clinical trials in accordance with protocol, GCP, and FDA regulations.
Medical Doctor
National Hospital
Abuja, NGR
04.2010 - 12.2014
- Worked with team providing acute medical care in the medical assessment unit
- Managed treatment of patients from admission to discharge
- Participated in quality management improvement and patient care programs as part of staff development program of the hospital
- Responsible for supervising and teaching House officers on call
- Served as technical/scientific subject matter expert in retrospective cohort trial on effects of sterilization on patients in northern Africa
- Assisted in developing and utilizing data gathering tools, such as surveys/questionnaires, work sampling, financial modeling, and/or interview questions, to ensure that appropriate quantitative and qualitative data is gathered for analyses
- Presented clinical, scientific and economic data to population-based decision-makers
- Suggested medical theories and implemented tests to confirm desired outcome of various diagnosis
- Led Medical Advisory board on strategy development and implementation
- Established health care partnership with KOLs including hematologists, neurologists, pediatricians, endocrinologists, gynecologists, and several mid level practitioners within the region
- Dealt with a wide spectrum of patients from different demographic and socio-economic backgrounds
- Communicated medical observations in simple language to help families better understand their situation
- Facilitated review and extraction of data for analysis/interpretation
- Participated in clinical trial for prospective birth control method in northern Africa
- Maintenance of systems for monitoring study progress, data quality and adherence to SOP's and procedures
- Extracted data for analysis and interpretation
- Participated in retrospective cohort trial on effects of sterilization on patients in Northern Africa.
Education
Master of Science - International Health
Liverpool John Moores University
UK01.2024
M.D. - Medicine And Surgery
Lautech College of Medicine And Surgery
NGR12.2009
Pre-Med - Basic Sciences
Ladoke Akintola College of Medicine
NGR 01.2004
Therapeutic Experience
- Oncology: Non-Small Cell Lung Cancer, CLDN 18.2 solid tumors, Advanced Solid tumors, Prostate cancer, Colorectal Cancer, Multiple Myeloma, Glioblastoma, Myelodysplastic syndrome
- Pain: Fibromyalgia, Diabetic Peripheral Neuropathy (Neuropathic pain), Migraine Postoperative Herniorrhaphy pain (surgery), Opioid study
- Rare Disease: Congenital Adrenal Hyperplasia, Lennox Gaustaut Syndrome (CNS), Thrombotic thrombocytopenic purpura (Hematology)
- Women’s health: Vasomotor Symptoms (Hot Flashes) Post-menopause, Levonorgestrel Implant
- CNS: Alzheimer’s disease, Cervical Dystonia, Traumatic Brain Injury (Vaccine), Myasthenia Gravis
- Dermatology: Atopic Dermatitis
- Psychiatry; Major Depressive disorder
- Endocrinology: Diabetes type II
- Ophthalmology: Macular Degeneration, Glaucoma
- Respiratory/Infectious: Covid -19 vaccine, Influenza A infection (vaccine), Clostridium Difficle, HIV (Pediatric)
- Musculoskeletal: Plantar Fibromatosis, Plantar Fasciitis
Additional Information
- Experienced with CRF design, clinical coding, First in Human/Early phase studies, study start up, Immunotherapy etc
- Proficient in Argus Safety, Medra, WHODrug
- Professional Affiliation: American Society of Clinical Oncology (ASCO), Nigerian Medical Association (NMA), ACRP
- Thought Leadership: Accomplished public speaker at local, regional, and national levels.
Timeline
Medical Director, Clinical Development
Prothena Biosciences Inc
02.2022 - Current
MD/ Lead Clinical Scientist
Syneos Health
09.2020 - 02.2022
Clinical Scientist
Syneos Health
09.2019 - 08.2020
Senior Clinical Research Associate
Pharm-Olam International
05.2016 - 09.2019
Clinical Research Associate
GlaxoSmithKline
02.2015 - 04.2016
Medical Doctor
National Hospital
04.2010 - 12.2014
Master of Science - International Health
Liverpool John Moores University
M.D. - Medicine And Surgery
Lautech College of Medicine And Surgery
Pre-Med - Basic Sciences
Ladoke Akintola College of Medicine