|We are seeking a Clinical MD to be involved in the planning and implementation of the Company’s clinical development program. This individual will participate in the design of all clinical trials necessary to verify product utility, safety and efficacy; and ensures that the scientific method is reflected in clinical protocols, data collection, and analysis. This individual will also be involved in the interpretation of findings.
Participates in the planning and coordination of world-wide clinical trials program.
Prepares summaries of clinical data for regulatory submissions.
Monitors progress of clinical trials relative to protocol preparation, recruitment of sites, patient accrual, and reporting, and writes protocols and investigator brochures; Takes corrective action to ensure timely completion.
Prepares manuscripts and scientific papers on the Company’s products and clinical findings.
Makes presentations and represents company at various industry or association meetings.
Furnishes information needed for Clinical Research/Operations, in preparation of clinical documents and presentations; and to Regulatory Affairs, in preparation of regulatory documents.
M.D. with Board Certification in Oncology, Immunology, Hematology or Rheumatology.
Otherwise, Doctorate (Ph.D.) degree or equivalent; or more than 10 years related experience and/or training; or equivalent combination of education and experience
Strong analytic and writing skills with publications
Experience in oncology and autoimmune diseases
Biotechnology and/or pharmaceutical industry experience
Experience with Phase I – III clinical trials
Knowledge of GCPs and regulatory requirements for clinical trials
Participation in large multi-center and/or global trials, investigational site management, data collection and interpretation, and study protocol compliance
State or Province