Senior Regulatory Pharmacology-Toxicology Consultant Position

Location:
Main Office: Alexandria, VA. Other offices in Cary, NC; San Mateo, CA; Mansfield, MA; Beijing, China and Tokyo, Japan. Successful applicant will work from their home office and report through the geographically relevant office.

Company:
Biologics Consulting Group, Inc. (BCG) specializes in providing expert regulatory and product development advice to the biopharmaceutical industry. The staff consists of experts in regulatory affairs, product manufacturing and testing, pharmacology-toxicology, statistics and clinical trial design and evaluation, each with extensive biologic product experience, and many with small molecules (drugs) experience as well. BCG currently consists of over 50 consultants, many with FDA experience, and offers a great deal of flexibility in meeting client needs. BCG can provide all levels of service ranging from that of a single senior consultant (CMC, pharm/tox, clinical, regulatory) to work on a specific set of tasks to the formation of an entire development team to provide all required consulting services to move a biopharmaceutical product from pre-IND through marketing application. The company has an excellent reputation both nationally and internationally, and continues to grow a client base that spans companies from small start-up companies to big pharma. This is an excellent opportunity for a regulatory toxicologist to work from a home office, thus avoiding the stress of a daily commute, while still interacting on a daily basis with clients and fellow BCG consultants as you work together on development teams to assist companies in moving their products to market. And since BCG works with clients that are developing biologics, therapeutic biologicals and drugs in most every category (vaccines, therapeutic proteins, cytokines, monoclonal antibodies, blood products, cell and gene therapy products, allergenic products, drugs, etc.) and for every indication imaginable, the work is always interesting and challenging. This is an excellent opportunity for a regulatory toxicologist who wants to share in the growth of this highly successful company and to further develop their skills and breadth of experience in this challenging area of biopharmaceutical development.

Position Description:
BCG is seeking a dedicated and professional regulatory toxicologist with excellent communication skills, a Ph.D. in an appropriate field (i.e. pharmacology, toxicology) and a number of years of experience in the area of regulatory toxicology. A knowledge of immunology is also desirable, as many of the biologics and therapeutic biologicals are designed to act through the immune system. This experience could come from working with a biopharmaceutical company, a toxicology CRO or the FDA, among others. The position is that of a senior regulatory toxicologist. This involves acting as an independent consultant working directly with biopharmaceutical companies to advise them on how best to move their products forward to market with respect to preclinical pharmacology-toxicology development. Responsibilities include planning of appropriate pharmacology-toxicology programs, interfacing with toxicology CROs, preparation for and participation in FDA meetings, writing and/or review of regulatory documents (pre-IND briefing packages, IND, BLA/NDA), review of toxicology data, and other responsibilities as required to move a biopharmaceutical product into the clinic and through marketing application. The senior toxicology consultant must hold the level of training and experience required to function as an independent consultant who will sometimes work alone with companies to provide consulting needs related to specific tasks, while at other times the consultant will serve as part of a BCG development team. Knowledge of FDA regulatory requirements in the area of preclinical pharmacology-toxicology are mandatory, while some knowledge and experience with other regulatory authorities (EMEA, Japan, etc.) would also prove useful. This is a full time senior toxicology consulting position, and BCG has grown to the point where there is plenty of work available in this area.

Requirements (Education and Experience):

• Ph.D. in Toxicology, Pharmacology or equivalent scientific discipline
  
• Knowledge of immunology is desirable
  
• Several years of experience in regulatory toxicology working with a biopharmaceutical company, toxicology CRO or regulatory agency such as the FDA
  
• Good understanding of the FDA and ICH requirements for preclinical pharmacology-toxicology development
  
• Some understanding of GLP regulations would be helpful
  
• Proven ability to work effectively both on an independent basis and collaboratively as a part of a development team
  
• Ability to work on multiple projects and work effectively with a broad spectrum of scientific disciplines
  
• Exceptional verbal and written communication skills
  
• Evidence that the applicant is motivated and has the high level of energy required to meet the challenging needs of this field
  
• Ability and willingness to travel (10-15% of time)

If interested, send CV and statement of interest to (no calls please):
Jim Kenimer, Ph.D, President & CEO, BCG, Inc

Page Updated: 4 March, 2008