• Operational oversight of early development clinical trial protocols, including First-in-Human, oncology patient studies.• Participation in preparation of clinical documents (i.e. protocols, study prototype informed consent documents, medical training materials, monitoring plan, etc.).• Coordinating study components to ensure timely study start-ups.• Coordinating study completion activities to ensure timely clinical study report delivery.• Conducts site initiation visits• Subject/patient level data review• Mentoring of new and junior level staff• Participates as a active member of the internal Risk Based Monitoring program (using TransCelerate model)

Clinical Trial Leader in Oncology early development responsible for:• Global Phase 2 multiple myeloma trial• Oversight of 2 additional studies managed by junior level staff• Management of study time lines to deliver on-time study start up• Preparation of clinical documents (i.e. protocols, study prototype informed consent documents, medical training materials, etc.)• CRO vendor management• Budget oversight to ensure cost effective study design and delivery• Mentoring for junior staff members

Clinical Scientist working in the therapeutic areas of Oncology, Inflammation, Transplantation, Infectious Disease• Participates in preparation of clinical documents (i.e. protocols, study prototype informed consent documents, medical training materials, monitoring plan, etc.).• Provide scientific/medical input, review and edit clinical study reports.• Member of extended data standards committee providing Medical Research input to Data Life-Cycle Packages for use across the Wyeth Global Clinical Team.• Medical Research representative on SOP committees.• Responsible for review of patient level data across a study.• Medical issue resolution.• Answer specific Site Management protocol questions as needed.• Track and reconcile SAEs across a study.• Assist with country and site feasibility.

Clinical Scientist Role:• Participates in preparation of clinical documents (i.e. protocols, clinical study reports, study informed consent documents, reference manuals, etc.).• Coordinates study components to ensure timely study start-ups.• Coordinates study completion activities to ensure timely clinical study report delivery.• Conducts site initiation visits.Clinical Research Associate Role:• Conducts site monitoring visits; site qualification visits & site close out visits.• Monitoring activities for a large phase 1B, multi-site, hepatitis C trial.• Assist in the resolution of site operational issues and data queries.

Operational activities associated with three phase 2 anti-inflammatory clinical trials.

-Study team leader for a large phase 3B renal transplant study; phase 2 and 3 renal transplant studies; 2 phase 1 oncology studies; and phase 2 hepatitis C study-Preparation of clinical documents (protocols, protocol amendments, study summaries);-Assist with the preparation of general medical reports and IND annual reports;-Assist with the development of case report forms and database validations;-Assisted with NDA related activities for two successful FDA filings of Transplantation immunosuppressive medication-Assisted with PLA related activities for the successful FDA filing of a pediatric gastroenteritis vaccine.

Preclinical Drug DevelopmentAssay Development