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Senior or Principal Consultant, Nonclinical Team

2 months ago

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

Sr./Principal Consultant – Cell & Gene Therapy Product Expertise

Position Summary:

The incumbent will have a Ph.D. preferably in Toxicology with previous experience at the Food and Drug Administration coupled with a broad base of drug product expertise to specifically include gene and cell therapy products. The ideal candidate will also be certified as a Diplomate of the American Board of Toxicology (DABT), however, this is preferred and not a requirement.

Anticipated travel requirements for the position will be approximately 20% based 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.

Duties and Responsibilities:

  • Serve as an expert in regulatory pharmacology/toxicology while providing direct consultation with biopharmaceutical companies to advise them on best approaches that will effectively advance drug development efforts from product development, provide ongoing support through early clinical stages through commercialization.
  • Determine the most appropriate regulatory pathway and support application process to the FDA while guiding clients through the approval process.
  • Preparation for and participation in FDA meetings to include overall strategy development and responses to FDA inquiries for new biologic applications.
  • Evaluation of nonclinical pharmacology and toxicology data.
  • Design of BLA-enabling nonclinical/toxicology packages and authoring study synopses.
  • Reviewing and/or authoring regulatory documents (e.g., pre-IND briefing packages, IND, BLA and/or NDA).
  • Provide ongoing support through early clinical stages to include assessment of the development risks and opportunities to identify drug development potential.
  • Evaluate product potential by examining current and future competition, market access consideration 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.
  • Opportunity to serve on cross-functional teams that include CMC, clinical, medical devices, regulatory affairs and operations.
  • 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 the internal and external teams responsible for delivery and develop junior team members.
  • The incumbent will lead by example and foster a team environment, ensuring an overall ‘culture of quality’ in the high-quality execution of services provided to clients.

Qualifications:

  • 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.