Derek Solum, Phd Email & Phone Number

Lead the Precision Medicine Initiative and support clinical development strategy and implementation at all stages, from contracting/outsourcing to study start up and study conduct, execution, and close out. Lead and manage large, global, multicenter clinical studies, prepares late stage clinical study protocols and study reports, regulatory submissions and and provides due diligence support for new expansion activities.

Raleigh-Durham, North Carolina Area

Experienced Product Development Manager with a demonstrated history of working in the pharmaceuticals and contract research organization (CRO) industries. Strong product management professional skilled in editing, Good Clinical Practice (GCP), molecular biology, and scientific writing. Support clinical development strategy, formation, and implementation at all stages of clinical development from contracting/outsourcing to study start up and study conduct, execution, and close out. Lead and manage large multicenter clinical studies, draft late stage clinical protocols and study reports, and drive clinical development strategies and provide due diligence support. Identify vendors (CROs, labs, medical writers, etc) with best strategic fit for clinical development. Support regulatory submission activities including authoring clinical sections of INDs and NDAs as well as annual documents including Investigator's Brochures, PBRERs, and DSURs.

Raleigh-Durham, North Carolina Area

Prepare most types of clinical and regulatory documents, including clinical study protocols and reports, Investigator Brochures, informed consent forms, IND and NDA submissions and annual reports, and site manuals for investigational drugs, biologicals, or medical devices. Lead and/or participate in internal and external project team meetings and liaise directly with customers on medical and technical writing issues.

Ph.D., Neurobiology And Anatomy

B.S., Biology, Chemistry, Psychology