Donald Betah
Medical Director - Clinical Development @Acelyrin, Inc
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WORK HISTORY
Medical Director - Clinical Development @Acelyrin, Inc
Agoura Hills, CA, US
TA: Immunology -[Hidradenitis Suppurativa, Non-Infectious Uveitis]• Make evidence-based recommendations on inclusion and exclusion, outcome measures and other aspects of overall study design.• Provide support to data analysis with key input on data interpretation and presentation, along with colleagues in statistics, PV-safety and regulatory affairs to the development teams. Experience in collaboration with statistics, safety and clinical operations functions is required.• Work closely with the Chief Medical Officer to ensure robust protocols and appropriate study oversight to deliver study objectives.• Standing member of clinical trial team and safety review groups.• Provide input into and review key internal and external reports such as Investigator Brochure, Risk Language, Informed Consent, study Protocols, study operations manuals, etc.• Demonstrated ability to interact with study site investigators regarding subject eligibility, dosing, safety and other clinical trial conduct issues as needed.• Contribute to writing of regulatory documents and responding to regulatory inquires in collaboration with regulatory lead and others as required.• Contribute as needed to key safety documents, in collaboration with PSPV and regulatory colleagues including the PADER, PSUR, DSUR, etc.• Provide clinical-scientific input into key safety documents, as required.• Provide guidance to managers before, throughout, and following clinical trials to ensure compliance for proper study conduct throughout the clinical trial development through execution.• Review data from clinical trials, including ongoing review of clinical trial safety data, laboratory data, ECGs, as required in collaboration with PSPV colleagues; liaise with the clinical development team and if requested with the ACELYRIN Safety Committees.• Review of non-clinical data as required.• Review of clinical pharmacology data as required.• Participate in evaluation of life cycle management opportunities.
EDUCATION
St. Matthews University school of medicine
Doctor of Medicine (M.D.)
The Johns Hopkins University
Masters in Biotechnology/MBA
Howard University
Bachelor of science
Howard University College of Medicine
NONE
ABOUT DONALD BETAH
Dynamic Clinical Development leader with 21+ years of biopharmaceutical industry experience in designing and developing study protocols, planning, providing study conduct oversight, medical monitoring, interpreting study results, reporting results, and co-authoring scientific publications for different types of clinical trials ranging from Phase 2-3, post-hoc retrospective analyses studies, and Phase 4 post-marketing requirement studies across multiple therapeutic areas [Endocrinology – Diabetes (8 years), Immunology (3 years)-[Dermatology - Hidradenitis Suppurativa (2 years), Ophthalmology - Non-Infectious Uveitis (2 years), Vaccines - Plague & Botulinum vaccines (3 years)], Pulmonology - COPD (2 years), Psychiatry – Schizophrenia, Depression, bipolar disorder, Alcohol Dependence (10 years), Hematology – Anemia of Chronic Disease (3 years)]. Vast experience in collaborating with clinical study stakeholders including biostatistics, safety, regulatory, data management, clinical operations, Regulatory agencies, CROs, third party vendors, Key Opinion Leaders, Medical Affairs, HEOR, and Site Investigators.
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