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Associate Consultant

2 months ago

Alexandria, United States Biologics Consulting Group Full time
Job DescriptionJob Description

Position Summary:

Depending on the level hired, incumbent will serve in a support role to more senior level consultants and participate as an active member of the nonclinical pharmacology/toxicology consulting team. The role will provide development opportunities to become an expert in regulatory toxicology by providing consultation with biopharmaceutical companies on the best pharmacology/toxicology approaches that will expedite product development for marketing authorization. Depending on the level, responsibilities include, but are not limited to, providing support in planning appropriate pharmacology-toxicology studies, identifying and interfacing with CROs, preparation for client meetings with US Food and Drug Administration (FDA), evaluation and summary of toxicology data, and reviewing and/or writing portions of regulatory documents (e.g. pre-IND briefing packages, IND, BLA, and NDA applications).

Duties and Responsibilities:

  • Serve in a supportive role to senior level consultants, providing consultation to clients on best approaches to effectively advance drug development efforts and/or provide ongoing support through early nonclinical stages through commercialization.
  • Assist with planning and overseeing appropriate pharmacology/toxicology studies, including identifying and interfacing with contract research organizations (CROs), study monitoring, and study troubleshooting activities.
  • Prepare for FDA meetings to include overall strategy development and responses to FDA inquiries for new drug and biologic applications.
  • Evaluate, synthesize, and summarize nonclinical pharmacology and toxicology data for written deliverables.
  • Review and/or assist with authoring regulatory documents (e.g., pre-IND briefing packages, IND, BLA and/or NDA applications).
  • Prepare safety assessments for drug product excipients and impurities.
  • Serve on cross-functional teams that include CMC, clinical, medical device, regulatory affairs and regulatory operations consultants.
  • Stay abreast of changing trends and current events within the biopharmaceutical industry.
  • Conduct literature searches and reviews to support client’s FDA applications.

Anticipated travel requirements for the position will be up to 20% depending on client requirements. This is a ‘remote work’ position however, the incumbent will be required to travel to Alexandria, VA headquarters up to twice per year for team meetings.

Qualifications:

  • Graduate degree in a related-scientific discipline from an accredited institution required (PhD preferred).
  • Possess knowledge and understanding of regulatory pharmacology/toxicology qualification
  • Educational and/or work background in pharmacology or toxicology required.
  • 0-3 years of within industry, consulting, CRO or the FDA, as well as having experience with one or more of the following technical areas:
    • Small molecule drugs, and/or gene and cell therapy products
  • Strong scientific and analytical ability
  • Excellent interpersonal skills
  • Must exercise rapid learning ability, attention to detail, and adaptability.
  • Must possess excellent computer skills and verbal and written communication skills.
  • Must be a team player, an organized analytical thinker, and have a high level of energy and self-motivation.