Vice President, Medical Affairs

Position Description

Vice President, Medical Affairs

?Biovest International

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Location: Biovest International, Worcester, MA

Reporting to: Chief Executive Officer

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The Vice President of Medical Affairs will be responsible for planning and directing all medical policies and programs for a growing company focused on cancer immunotherapeutics. The Vice President will have responsibility for advancing the development of the company?s clinical programs as we conduct clinical trials for our non-Hodgkins Lymphoma vaccine and future products.

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Responsibilities:

?Designs, implements and monitors clinical studies of compounds designated for clinical development.Develops protocols and case report forms to provide efficacy and safety information for all phases of clinical trials.Interacts with data management personnel to plan data entry and analysis.Identifies competent investigators and/or agencies and maintains regular meetings with same.Assures that cGMPs are followed throughout clinical trials.Assures timely completion of studies.Monitors data for safety and efficacy trends by regularly and thoroughly reviewing clinical data.Writes clinical reports upon completion or termination of studies.Authors the clinical content in marketing materials.Reviews requests for results of Investigational New Drugs (IND) studies, and provides input for pharmacokinetic and pre-clinical studies.Prepares clinical portions INDs, New Drug Applications (NDAs) and Biological License Applications (BLAs), including protocols, investigator brochures, medical reports, medical reports, efficacy and safety summaries, scientific rationales and benefit risk/ratios.Plans clinical programs and develops timetables, budgets and resource analyses to support trials and release of product.Establishes and maintains relationships with all engaged parties to optimize performance on clinical trial activities.Prepares manuscripts for technical journals and makes presentations at scientific meeting.Other duties as required.

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Qualifications

?A M.D. or M.D. /Ph.D. degree in a relevant scientific discipline with a minimum 5-8 years? experience in Oncology clinical research with evidence of progressive advancement, preferably in the biotechnology industry.A record of scientific achievement in Oncology as indicated by publications, professional advancement and leadership positions.Strong management and organizational skills with evidence of having led scientific groups and or organizations.Strong speaking, writing and presentation skills. Ability to communicate clearly with both scientists and non-scientists alike.Must have a strong working knowledge and understanding of non-Hodgkins follicular lymphoma. Experience with or familiarity with cancer immunotherapies and or vaccines a definite plus.

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No relocation assistance available.

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About Biovest International

Biovest International is a publicly traded biotechnology company that develops personalized immunotherapies for life threatening cancers of the blood system. Biovest is the holder of a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute for the commercialization of BiovaxID, a personalized biologic therapeutic cancer vaccine for the treatment of non-Hodgkin?s lymphoma. This therapy, referred to as BiovaxID, is currently in a phase 3 pivotal trial at 24 major medical institutions in the US.

Biovest has a long history of manufacturing biological drugs from small research scale quantities to large volumes for Phase 1 and Phase 2 clinical material.? In addition, Biovest International develops, manufactures, and markets patented cell culture systems and equipment, including the innovative AutovaxID instruments, to pharmaceutical, diagnostic and biotechnology companies, as well as leading research institutions worldwide.? Learn more about Biovest at www.Biovest.com.