Jeff Simpson Email & Phone Number

Morrisville, NC

Raleigh-Durham, North Carolina Area

I joined UCB Biosciences in December 2010 as a Sr. Clinical Project Manager.My primary responsibility in this role was management of clinical studies of a biologic for rheumatoid arthritis.

* I am responsible for developing complex study specific concept sheets and protocols supporting multiple clinical development programs. Duties include leading major protocol review and discussions concerning scientific and procedural aspects of study design. I have authored multiple protocols and amendments, ranging from phase 1b to phase 3 clinical.

(Note: Schwarz Biosciences was acquired by UCB Pharma)Key Tasks: * Responsible for developing, leading, and implementing the lacosamide epilepsy monotherapy clinical development program in support of registration of a line extension. * Responsible for developing, leading, and implementing the lacosamide (Vimpat®) epilepsy phase 3b clinical program 3 year.

Key Tasks:* Responsible for preparation, conduct, and reporting of clinical trials in a high quality and timely manner to support regulatory filing of lacosamide for treatment of neuropathic pain. * Trial Manager for a phase 2 proof-of-concept trial, phase 2b dose-finding trial, and phase 3 trial in subjects with painful diabetic neuropathy as well as the.

* Serve as Clinical Scientist for a world-wide phase 3 clinical trial. Related duties include: coordinate clinical trial agreements with pharmaceutical companies (i.e., investigational product supply, adverse event reporting, publication approvals); write amendments to the protocol as necessary; present scientific overview and results at Investigator.

Key tasks:* Assist in coordinating phase IIIB/IV collaborative clinical trials within the HIV Market Support group by setting the agenda of study proposals for review by the International Medical Affairs (IMA) Collaborative Studies Review Committee (CSRC), participating in CSRC meetings, and presenting incoming proposals and protocols to the CSRC.*.

Key tasks:* Serve as an assistant to the Lead CRA on an assigned project: provide assistance to the Lead CRA with project-related duties and/or conduct necessary tasks for project operation.* Develop monitoring guidelines, project specific materials, and other monitoring tools to assist team members and site staff in the performance of a clinical trial.*.

Fellowship through Univ. of North CarolinaKey tasks:Design, supervise, and participate in various research projects investigating neurodegenerative diseases (temporal lobe epilepsy, Parkinson's disease, Alzheimer's disease, AIDS-related dementia, stroke).Employ a broad spectrum of surgical, neuroanatomical, and molecular techniques including use of.