Associate Consultant, Nonclinical

BIOLOGICS CONSULTING GROUP INC•Alexandria, VA

About The Position

The Consultant, Nonclinical is a mid-level role responsible for managing and contributing to the successful execution of client projects, within the nonclinical toxicology discipline and with projects that are complex or of a cross-functional nature. This role involves significant involvement in the development and completion of project deliverables, such as technical reports, research, and U.S. Food and Drug Administration (FDA) regulatory submission support. The Consultant may also assist with managing client relationships, support proposal development, and is accountable for meeting individual financial performance targets. The position requires demonstrated subject matter expertise, strong project management and communication skills, and the ability to work effectively across multiple projects and teams. The Consultant is also expected to engage in ongoing professional development and contribute to knowledge-building within their area of specialization. Biologics Consulting Group, Inc. works with medical device, biologics and pharmaceutical companies to advance patient health.

Requirements

Ph.D. in a related scientific discipline (e.g., Toxicology, Pharmaceutical Sciences, Pharmacology, etc.) from an accredited institution strongly preferred, with at least 3-5 years of relevant industry, consulting, and/or FDA experience.
Alternatively, a Master’s degree in a related discipline and at least seven years of relevant experience.
Prior consulting experience and/or direct FDA or other regulatory interactions strongly preferred in the area of nonclinical toxicology.
Proven ability to significantly contribute to scientific projects and work independently.
Strong technical writing, analytical, and research skills related to nonclinical toxicology and pharmacology.
Knowledge of regulatory pathways and nonclinical strategy development, including familiarity with alternative approaches to regulatory challenges.
Effective interpersonal communication 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.

Nice To Haves

Ph.D. in a related scientific discipline (e.g., Toxicology, Pharmaceutical Sciences, Pharmacology, etc.) from an accredited institution strongly preferred
Prior consulting experience and/or direct FDA or other regulatory interactions strongly preferred in the area of nonclinical toxicology.

Responsibilities

Assist in the coordination and management of scientific projects within the nonclinical technical discipline and also across multiple therapeutic areas.
Contribute to the development of high-quality deliverables, including regulatory documents, technical reports, and literature reviews.
Provide quality control for work authored by junior team members and ensure deliverables meet client and regulatory expectations.
Support and contribute to proposal preparation for new business opportunities.
Manage or support client relationships, including communication and delivery of project milestones.
Collaborate effectively with team members and cross-functionally across multiple concurrent projects.
Manage competing priorities effectively while meeting deadlines and maintaining high-quality work.
Exhibit strong verbal and written communication skills, tailored to scientific and professional audiences.
Maintain responsibility for meeting individual financial performance targets.
Participate in ongoing professional development and expand expertise within a specialized subject area.
Lead by example and foster a team environment, ensuring an overall ‘culture of quality’ in the high-quality execution of services provided to clients.