David E Smith

Distinguished medical and scientific communications leader with extensive experience across the biopharmaceutical, diagnostics, and medical technology sectors. Proven track record in the following areas:

• Medical Writing Leadership: Directed teams as Senior Medical Writer and Director, producing manuscripts for peer-reviewed journals, abstracts, and congress presentations. Skilled at aligning messaging with senior management, scientific, and commercial teams.

• Strategic Publication Planning: Developed and executed publication strategies that align with corporate goals, leading activities for journals and scientific congresses and demonstrating deep knowledge of the publication landscape.

• Process Optimization: Improved operational efficiency by reducing manuscript drafting time by 25% at Scipher Medicine and cutting preparation time by one month at Biotheranostics/Hologic through streamlined processes and standardized tools.

• Regulatory and Clinical Documentation: Authored clinical trial protocols, collaborated with statisticians, and produced study reports and regulatory documents at Pathnostics, highlighting expertise in regulatory writing and clinical research.

• Multimedia and Educational Content: Created medical training modules in neurology, oncology, and immunology at Science Media, demonstrating versatility in scientific communication.

• Program and Operations Leadership: Held senior roles such as Director of Neurodegenerative Diseases Program at BioRegenerative Sciences (led ALS therapy development) and Executive Vice President at Aviva Biosciences (oversaw strategy and operations for growth).

• Alliance and Partnership Management: Established and managed clinical genomics alliances at Illumina, and led multiplex assay development and regulatory submissions at Luminex.

• Team Leadership: Managed cross-functional teams, including 11 PhD and MD Technical Directors at The Binding Site, overseeing conference presentations and manuscript development.

• Scientific Education: Authored and delivered Continuing Medical Education and Grand Rounds presentations at Quest Diagnostics, underscoring expertise in scientific education.

Skills:

• Medical Writing & Communication: Manuscripts, abstracts, regulatory documents, protocols

• Strategic Planning: Publication plans, congress management, communication alignment

• Process Improvement: Workflow optimization, documentation standardization, SOP implementation

• Cross-functional Leadership: Team management, vendor coordination, stakeholder engagement

• Regulatory Documentation: Clinical trial protocols, regulatory submissions, compliance

• Educational Content: Multimedia modules, scientific education delivery

• Alliance Management: Strategic partnerships in genomics and diagnostics

• Therapeutic Area Expertise: Neurology, oncology, immunology, diagnostics, neurodegenerative disease leadership