Note: The job is a remote job and is open to candidates in USA. Biologics Consulting Group, Inc. works with medical device, biologics, and pharmaceutical companies to advance patient health. The Senior Consultant, Nonclinical leads complex nonclinical pharmacology and toxicology consulting projects, manages client relationships, develops regulatory deliverables, supports business development, and mentors junior staff.
Responsibilities
- Serve as the senior project leader or provide support, as needed, for client delivery of project work
- Accountable for quality and delivery of client work while providing direct consultation to advise clients on best approaches that will effectively advance product development efforts, including ongoing support from early development through clinical stages and commercialization
- Contribute to the development of high-quality deliverables, including regulatory documents, technical reports, and regulatory strategy planning documents
- Provide quality control for work authored by junior team members and ensure deliverables meet client and regulatory expectations
- Delegate and oversee tasks across junior team members to optimize workflow and promote development of junior staff
- Independently manage client relationships and act as a key point of contact for project execution and issue resolution for projects on which the senior project leader role is held
- Support business development efforts by identifying opportunities within existing client accounts and identifying new opportunities, as well as participating in proposal development and review
- Maintain responsibility for meeting individual financial performance targets
- Actively participate in mentoring and coaching activities for junior-level team members, sharing expertise in project execution, scientific writing, and regulatory knowledge
- Engage in thought leadership efforts to increase visibility as a subject matter expert in nonclinical toxicology
- 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
Skills
- Alternatively, a master's degree in a related discipline with at least ten years of relevant experience
- Proven ability to lead scientific projects and manage external client and/or stakeholder engagements independently
- Demonstrated success in business development and sales growth, primarily through existing client relationships
- Strong technical writing, analytical, and research skills
- Expert knowledge of pharmaceutical regulatory pathways and strategy development, including familiarity with alternative approaches to regulatory challenges
- Effective interpersonal communication and mentoring skills
- Ability to manage competing priorities in a dynamic, deadline-driven environment
- Ability to create effective PowerPoint presentations and leverage current software and tools
- Proficient in Microsoft Office Suite, keyboarding skills, strong documentation skills, math aptitude, diplomacy and leadership skills, professionalism, time management, ability to multitask, able to work independently as well as collaboratively, and able to maintain confidentiality
- Ph.D. in a related scientific discipline (e.g., Toxicology, Pharmaceutical Sciences, Pharmacology, etc.) from an accredited institution strongly preferred, with at least 5-7 years of relevant industry, consulting, and/or FDA experience in the area of nonclinical drug development
- Prior nonclinical toxicology consulting experience and/or direct FDA or other regulatory interaction strongly preferred
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