Senior Consultant, Cell and Gene Therapy Expert

2 weeks ago

Alexandria, Virginia, United States Biologics Consulting Group Full time
Sr./Principal Consultant – Cell & Gene Therapy Product Expertise

Biologics Consulting Group is seeking a highly experienced Sr./Principal Consultant to join our team. As a key member of our Nonclinical Team, you will provide expert regulatory pharmacology/toxicology guidance to biopharmaceutical companies, helping them navigate the complex regulatory landscape and advance their drug development efforts.

Key Responsibilities:

  • Provide strategic guidance on regulatory pharmacology/toxicology to biopharmaceutical companies, ensuring compliance with FDA regulations and guidelines.
  • Determine the most appropriate regulatory pathway for clients, supporting them through the approval process and FDA meetings.
  • Evaluate nonclinical pharmacology and toxicology data, designing BLA-enabling nonclinical/toxicology packages and authoring study synopses.
  • Review and/or author regulatory documents, including pre-IND briefing packages, IND, BLA, and NDA.
  • Provide ongoing support through early clinical stages, assessing development risks and opportunities to identify drug development potential.
  • Evaluate product potential by examining current and future competition, market access considerations, and conducting SWOT analysis.
  • Biocompatibility assessments for devices and combination products, safety assessments for product excipients and impurities.
  • Opportunities to participate in the entire development plan from development planning to pre-IND, IND, BLA/NDA, and commercialization.
  • Leading and influencing frequent interactions for pre-submission activities with regulatory authorities.
  • Leading client meetings and conducting client liaison on an ongoing basis.
  • High-level strategic review and input on client packages.
  • Provide scientific insight for new business pitches and proposals.
  • Conduct due diligence on behalf of clients and develop risk management strategies.
  • Presentations and thought leadership to expand business.
  • Build collaborative relationships with stakeholders and manage internal and external teams responsible for delivery and develop junior team members.

Requirements:

  • Ph.D. in Toxicology strongly preferred. Terminal degree in a related scientific discipline from an accredited institution required.
  • Diplomate of the American Board of Toxicology (DABT) Certification preferred.
  • Seven to fifteen years within the Food and Drug Administration, as well as having experience with a broad base of products including cell and gene therapy products.
  • Additional years of experience within industry, consulting, CRO, or other national regulatory agencies would be a plus to the previously listed requirements.
  • Excellent knowledge of the pharmaceutical/biotechnology industry.
  • Excellent interpersonal skills.
  • Must exercise rapid learning ability, sharp attention to detail, excellent computer skills, excellent oral and written communication skills, team player, organized, analytical thinker with a high level of energy and self-motivation.
  • Demonstrated versatility in conflict resolution, problem-solving, and working effectively as a part of a cross-functional organization.
  • Demonstrated focus in exceeding client expectations.
  • Ability to manage organizational change.
  • Recognition as an expert in the field of expertise.
  • Understanding of registration procedures and requirements as well as product life cycle management from a regulatory affairs perspective.
  • Possess an intuition for the needs of the client and the ability to adjust to those needs.
  • Ability to work within deadlines and solve challenges in a pragmatic and proactive manner.
  • Ability to dig into the details while keeping an eye on the overall goal of the project.
  • Must be able to effectively delegate to team members.
  • Direct consulting experience in regulatory affairs, industry, and/or regulatory authorities specifically in the pharmaceutical industry preferred but not required.
  • Skilled in personal interactions within multicultural teams, including the ability to challenge other experts when deemed necessary.
  • Flexibility to work across different therapy areas.
  • Previous experience leading people, functions, and/or projects.
  • Ability to create effective PowerPoint presentations and leverage current software and tools.

Essential Skills:

Proficient in Microsoft Office Suite, keyboarding skills, strong documentation skills, math aptitude, diplomacy and leadership skills, professionalism, time management, ability to multi-task, able to work independently as well as collaboratively, able to maintain confidentiality.

The requirements listed are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

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