Shawn Hakim

About Shawn Hakim

A clinical science leader and entrepreneurial researcher with 20+ years of experience in pre-clinical/clinical research in oncology/hematology, immunology and neuroscience/neurology therapeutic areas working with key opinion leaders, clinical investigators and healthcare professionals in both industry and academia. Uniquely trained and experienced in clinical research strategies, medicine development, medical/regulatory affairs, research regulation/review, grant writing, clinical trials management/operations, and business development. Proven track record of leading clinical programs that supported the successful development and market approvals of transformative therapies

Experience

1. Director, Global Clinical Lead, Oncology R & d

   GSK

   Apr 2020 — Present · Upper Providence, PA, US

   Lead a clinical matrix team and ensure patient safety is of paramount importance during the study lifecycle, that study objectives fulfill regulatory and reporting requirements, and support medical governanceEnsure delivery of quality study strategy and design, understand the analysis and interpretation of data throughout the studyLead and contribute to the end to end (protocol concept to final study report) delivery of clinical development activities which ensure consistency with the clinical development strategy for regulatory approvals, reimbursable medicines, and successful lifecycle management; demonstrate ability to incorporate global considerations into strategic and operational decisionsPresent the scientific rationale and study design at Investigator Meetings and respond to scientific questions arising from sites during study conductContribute to understanding of asset’s biological mechanism, clinical strategy, scientific interpretation of disease and target-based literatureIntegrate data from internal, and external academic, conference, and competitor sourcesInteract with Key External Experts (KEEs), Key Opinion Leaders (KOLs), collaborators, advisory boards, etcEnsure the high quality of protocol documents are developed aligned to the CDP to effectively determine a medicine’s potential efficacy, safety profile, key areas of product differentiation and value to patient in the shortest possible timeframeDrive/Contribute to clinical components of the IB, and documents for regulatory submissions and advisory requirement, including scientific advice, IND, EoP2, pre-NDA/BLA meetings, NDA/BLA and MAA documentsAccountable for Phase 1-4 study design, including clinical pharmacology study designs supporting the CDP Contribute to all regulatory reporting requirements (e.g, DSUR, INDSRs, etc.) and ensure prompt, quality responses to Institutional Review Boards (IRB)/Ethics Review Committees (ERC), Independent Data Monitoring Committees (IDMC)

Education

• Albany Medical College

  Graduate Student, Cell Biology and Cancer Research

• Harvard University

  Master of Science (MS), Cell Biology/Biotechnology Project Management

• University of Connecticut

  Bachelor of Science (BS), Molecular & Cell Biology, Physiology & Neurobiology and Psychology

• Virginia Commonwealth University

  Doctor of Philosophy - PhD, Cancer and Molecular Medicine