Position available: President/CEO (click for full job ad)

Biologics Consulting Group, Inc. (BCG), a nationally recognized biopharmaceutical product development and regulatory consulting firm, with offices in Alexandria, VA (head office); Cary, NC; Franklin, MA; San Francisco, CA, and Tokyo, Japan, is seeking candidates for the position of President and Chief Executive Officer (President/CEO).

Specific Role:

BCG has developed a prominent reputation in the biopharmaceutical regulatory community. The President/CEO will be expected to represent BCG in a manner which will continue to grow and enhance that reputation.

The President and CEO will assume full operational and executive responsibilities for the day-to-day activities of BCG, operating from its head office in Alexandria, VA. and will report directly to the Board of Directors.

Qualified candidates should forward their CV and statement of qualifications for the position to:

STEPHEN RHODES, M.S.

Stephen P. Rhodes, M.S. joined Biologics Consulting Group, Inc., as a Senior Consultant (Medical Devices) in March 2010. Mr. Rhodes comes to BCG with a wealth of knowledge from over 20 years of experience with the Food and Drug Administration, Center for Devices and Radiological Health. Mr. Rhodes will utilize his broad technical and regulatory expertise to assist clients in the following areas: Short and long term regulatory strategy for medical device technologies, biomaterials, combination products and tissues, assisting clients with navigating the regulatory process and developing preclinical and clinical testing plans, representing clients in interactions with FDA, assisting clients in preparing for FDA meetings and FDA Advisory Panel meetings, preparing and assisting in the preparation of RFDs, Pre-IDEs, IDEs, HDEs, 510(k)s and PMAs and providing clients with a comprehensive "FDA style" review of submissions.

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CRAIG HALVERSON, M.S.

Craig A. Halverson joined the Biologics Consulting Group, Inc. as a Senior Consultant in May, 2010. Craig has over 25 years of scientific, regulatory and quality experience in the biopharmaceutical and in vitro diagnostics industries. This experience was gained at six biotechnology companies, a clinical reference laboratory, and an in vitro diagnostics company. He is an experimental pathologist with product development experience that spans pre-clinical characterization, manufacturing process and analytical method development through IND and BLA/NDA acceptance.

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OREST HURKO, M.D.

Orest Hurko, M.D. joined Biologics Consulting Group, Inc., as a Senior Clinical Consultant (Neurologic and Mendelian Disorders, Translational Medicine) in June 2010. Orest comes to BCG with 12 years of experience in the Pharmaceutical Industry in SmithKline Beecham, GlaxoSmithKline, Wyeth and Pfizer. Most recently, he was Assistant Vice-President, Translational Medicine, Pfizer, and, previously, Director of the Translational Medicine Research Collaboration between Wyeth, the Scottish National Health Service, Scottish Enterprise and the Universities of Aberdeen, Dundee, Edinburgh and Glasgow. Orest had oversight for biomarker development and validation for all therapeutic areas, including Neuroscience, Cardiovascular, Oncology, Inflammation, and Women’s Health. He has played a leading role in academic-industrial collaborations as a founding member of the Alzheimer Disease Neuroimaging Initiative (ADNI) where he continues on the Publications Core and the Industrial Scientific Advisory Board. His group at Wyeth made the first joint Voluntary Genome Data Submission to the FDA and the EMEA.

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REBECCA SPENCE, PH.D.

Rebecca (Becky) Spence, Ph.D. joins Biologics Consulting Group, Inc., as a Medical Writer in February 2010. Becky comes to BCG with 10 years of experience in the clinical development industry, with Expertise in evaluating clinical data and communicating science through clinical, regulatory, and commercial documents.

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Position available: Vaccine Regulatory Expert – Senior Consultant level

Biologics Consulting Group, Inc. is recruiting for a Senior Consultant with extensive experience in vaccine regulatory approval and product development.  We are experiencing a significant increase in requests for vaccine-related regulatory consulting services and seek to add to our current team of experts.  Prior FDA and/or senior regulatory affairs management experience with vaccine products a requirement.  Familiarity with EMA and WHO vaccine policies and procedures highly desirable.  Minimum 15 years experience and advanced degree (PhD, MD, MPH) required.  No geographical requirements as all BCG consultants are home-office based.  Excellent compensation and benefits package available. 

Qualified candidates should forward their CV and statement of qualifications to Jim Kenimer, CEO at:

BCG consultants attend numerous conferences every year during which they are available to provide company information or consulting expertise. Below are some conferences that BCG consultants will be attending in the near future. Please feel free to contact the attending consultant either before, or during the conference for company information or to discuss a business opportunity.

Recovery of Biological Products XIV

Session: QbD in practice – Reconciling regulators expectations and industry implementation