Remote Toxicology Consultant

We consult the pharmaceutical and biologic product industry in nonclinical (pharmacology and toxicology) clinical pharmacology and related regulatory areas. Our nonclinical consultation consists of strategic advice, overall program design, study placement and monitoring, regulatory document preparation, and position papers. Our consultants are located throughout the US and work virtually from their home offices. Our main office is in the Washington D.C. metro area, although this is a permanent remote position.

Provide strategic and operational toxicology advice to the pharmaceutical, device, and biologics industries. Serve as toxicology subject matter expert for client company project teams where appropriate. Toxicology Consultants provide clients with scientific expertise, nonclinical regulatory expertise and guidance in regulatory interactions, and recommendations on overall toxicology program design, study placement and monitoring, report preparation, regulatory document preparation, and development of position papers.

Responsibilities:

• Consistently meet billable hour targets
• Demonstrate and clearly articulate an understanding of the needs of each client
• Effectively communicate with clients directly and manage the relationship where appropriate; always exhibit professional conduct when interacting with clients
• Provide scientific and innovative thinking with an advanced level of technical skill and insight
• Effectively communicate with health authorities, both in writing and in regulatory meetings, on behalf of clients
• Effectively manage deadlines and project budgets, multi-task, and work well with internal staff and clients resulting in a high-quality work product and on time delivery
• Engage directly or assist in the publication of relevant articles and presentations or symposia at professional meetings
• Participate in the training and development of operational staff
• Model, promote, and demonstrate collegiality
• Maintain current scientific knowledge by initiating the appropriate internal or external educational/learning pursuits
• Ensure personal development goals are in place and carried out in agreed timeframe

Requirements:

• Advanced degree in a life science or related field of study (PhD or DVM) required
• Minimum of 7 years relevant pharmaceutical research and development, and/or regulatory agency experience
• Demonstrated ability to provide strategic guidance
• Good organizational skills
• Good people skills
• Excellent written and oral communication skills in English
• Ability to effectively meet deadlines
• Ability to function effectively alone or as part of a team