Bilal Bham

Lead and scale a senior bench across Regulatory Affairs, Medical Affairs, Market Access, IR, and Marketing Communications; own strategy, governance, and P&L Direct cross-functional workstreams (Clinical, Safety, Biostats, MAx) to unified narratives and timelines Institute SOPs/QC/templates; drive inspection-/audit-ready outputs and editorial standards

CEO & Principal Consultant at Amodaia Ltd (2011-06 – Present)

• Lead and scale a senior bench across Regulatory Affairs, Medical Affairs, Market Access, IR, and Marketing Communications; own strategy, governance, and P&L
• Direct cross-functional workstreams (Clinical, Safety, Biostats, MAx) to unified narratives and timelines
• Institute SOPs/QC/templates; drive inspection-/audit-ready outputs and editorial standards
• Partner with C-suite/VPs to align regulatory, scientific, access, and investor storylines
• Deliver high-stakes documents: Protocols, IBs, CSRs (Ph I–III), IND/IMPD, CTD sections, RMPs, HA responses
• Produce publication plans/deliverables, HCP education, payer/value decks, craft investor decks and executive summaries
• Deploy AI-enabled operating system for faster, compliant drafting, fact-checking, and version control

CEO & Principal Consultant at mychedelica Ltd (2023-06 – Present)

• Brand/community platform for the psychedelic's ecosystem (education, partnerships, content)
• Commercial consulting routed via Amodaia to maintain compliance and focus

Medical Writer at Renovo Ltd (2010-08 – 2011-06)

• Phase II–III CSRs; IB updates, Manuscripts, abstracts, posters, and presentations

Medical Writer at Sanofi GmbH (2007-10 – 2010-07)

• Phase I CSRs; IBs; IND/IMPD - Coordinated delivery across EU/US/JP teams

Associate Medical Writer at Caidya (2006-10 – 2007-09)

• Training in regulatory writing, QC, and full-lifecycle CSR production; developed robust time- and quality-management

MSc in Immunology & Immunogenetics – University of Manchester (2004-09 – 2005-08)

BSc (Hons) in Genetics, with industrial placement – University of Manchester (2000-09 – 2004-06)