Regulatory Toxicology Consultant; Senior-Level

Position: REGULATORY TOXICOLOGY CONSULTANT (SENIOR-LEVEL) Sci Lucent, Inc. (), a partially employee-owned Northern Virginia-based scientific consulting firm is dedicated to providing innovative solutions in all aspects of drug development. We are committed to helping our clients navigate the complexities of the pharmaceutical industry to achieve their goals. We are seeking an experienced Regulatory Toxicologist to join our multidisciplinary consulting team as an Associate Principal or Principal Consultant, depending on level of knowledge, skills, and experience. This senior role within the Nonclinical Safety & Development team requires a professional capable of operating with a high degree of independence across the services we offer. The successful candidate will be expected to lead nonclinical strategy development and client engagements, design and oversee studies, provide regulatory and scientific guidance and authoring, and represent Sci Lucent as a subject-matter expert in the development and execution of programs for drugs, biologics, devices, and combination products across multiple therapeutic areas. Essential Duties and Responsibilities:

• The candidate will devise and execute moderately complex to complex integrated nonclinical development strategies to support the development activities of drugs, biologics, devices, and combination products.
• Act as a trusted advisor to drug development clients, providing strategic support on nonclinical strategies and activities
• Advise, guide, and design integrated national and international nonclinical drug development strategies for our clients
• Provide oversight and management of program outsourcing activities
• Review, analyze, and interpret complex scientific data, and effectively communicate data interpretation to project teams, clients, and regulatory agencies
• Author and/or critically review nonclinical submission packages for scientific content and quality
• Act as nonclinical representative for Agency interactions and meetings
• Conduct scientific assessments (e.g., gap analysis, safety assessments)
• Assist in the preparation of proposals and presentations tailored to client needs and business development goals

Job Requirements:

• Advanced degree (PhD or MS) in toxicology or a related and relevant scientific field
• 7 or more years' experience working in nonclinical development, toxicology, and/or veterinary medicine in the pharmaceutical, biotechnology, life sciences consulting and/or contract service industries
• Prior experience and knowledge in working with Contract Research Organizations (CRO) including general study design and conduct, study monitoring, technical and scientific aspects of study execution including common routes of administration and species
• Must possess current knowledge and expertise in regulated drug development processes
• Excellent track record of successfully authoring quality nonclinical regulatory documents
• Knowledgeable in regulatory guidance documents, precedents and GLP regulations
• Excellent communication skills and ability to effectively address scientific and regulatory questions under pressure
• Strong sense of teamwork and demonstrated experience working with project teams, clients and regulatory personnel
• Must be detail-oriented, with an ability to think critically and innovatively
• Demonstrated track record of managing multiple projects and client accounts simultaneously, preferably in a consultancy setting
• Ability to synthesize complex technical information and present it clearly to diverse audiences.
• Must have a client service minded attitude and be able to travel

This is a remote position working from your home location with travel as needed for client and business needs. We are a small company and at this time are unable to sponsor candidates for employment. Our most valuable resource is our people. We hire intelligent, creative, passionate professionals with a strong desire to learn. At its core - collaboration, camaraderie, growth, and collective hard work without egos - our culture is one that encourages, supports, and celebrates our colleagues! We offer a congenial, supportive, and flexible work environment, the opportunity to work with knowledgeable… Apply tot his job Apply To this Job