Salamandra’s Nonclinical Pharmacology/Toxicology Regulatory Consultant will support our nonclinical practice area. This person will be responsible for leveraging their scientific and regulatory nonclinical pharmacology and toxicology expertise to support clients through the various phases of drug development while working closely with a multi-disciplinary development team to ensure solutions are comprehensive and tailored to each client’s unique needs.
The candidate filling this role will also contribute to the growth and expansion of Salamandra’s nonclinical offerings and resources by playing a key role in identifying and pursuing opportunities to market and sell nonclinical pharmacology/toxicology services to new and existing clients, as well as grow the depth of resources of the nonclinical department within Salamandra, with assistance and support from the leadership team.
Specific responsibilities of this position include, but are not limited to:
- Writing, as primary author, coordinating the preparation of, and critically reviewing nonclinical content for documents submitted to regulatory agencies (e.g., INDs, NDAs, BLAs, MAAs, Meeting Briefing Packages, IBs, Annual Reports, etc.) and other documents supporting strategic development (e.g., Gap Analyses, Development Plans, etc.).
- Providing regulatory and scientific subject matter expertise to support the development of drugs and biologics and providing regulatory input for nonclinical development activities.
- Providing support and advice to clients on the design, interpretation, and associated risks of nonclinical studies (e.g., pharmacology; toxicology; absorption, distribution, metabolism, and excretion [ADME]; toxicokinetics (TK); and safety) and on Good Laboratory Practice (GLP) requirements for programs as needed.
- Advising clients on and/or providing interpretation of relevant regulatory requirements (e.g., for FDA, Health Canada, EMA, etc.).
- Collaborating cross-functionally with other organizational practice areas (e.g., CMC, clinical); communicating with clients and project managers regarding technical issues, timelines, deliverables, etc.
- Providing training and mentorship to internal staff, clients, and external vendors as needed.
- Researching or guiding research of relevant regulatory precedent (e.g., as established by actions of FDA, Health Canada, EMA, etc.) to support preparation of deliverables.
- Overseeing the conduct and review of systematic literature searches that are intended to support nonclinical deliverables.
- Monitoring and staying up-to-date on scientific advancements, regulatory requirements, and industry trends relevant to nonclinical research and development in the pharmaceutical industry.
- Upholding and adhering to Salamandra’s quality standards; supporting/participating in, as needed, Quality System-related activities.
- Identifying and pursuing new business opportunities, leading to the expansion of Salamandra’s nonclinical pharmacology/toxicology services; demonstrating the ability to grow client relationships and increase the department’s resources, contributing to the company’s overall growth and market presence.
- Supporting business development activities, such as drafting and/or researching information for scopes of work, proposals, or similar engagements, as needed.
Success Factors
Successful performance in this role is predicated on the ability to:
- Communicate effectively, orally and in writing, in a clear, succinct, and organized manner that is appropriate for the audience.
- Think quickly and creatively in fast-paced, high-pressure situations; anticipate client needs and develop strategies and/or recommendations to address them.
- Analyze information, use sound judgment, and research precedents to generate/evaluate proposed and alternative approaches, draw logical conclusions, and make recommendations.
- Serve as a resource on multiple projects concurrently and demonstrate flexibility in response to new information, changing conditions, unexpected obstacles, or client needs.
- Communicate risks, updates, and emerging issues proactively.
- Strategic business development and relationship building acumen.
- Be thorough and conscientious to ensure work product/information is complete, accurate, and of the highest possible quality.
- Work both independently as well as collaboratively across all levels of the organization in an engaged, matrixed leadership environment to achieve common goals and positive results.
- Manage workload and priorities to meet internal deadlines and ensure the timely preparation and finalization of client deliverables.
Minimum Qualifications
- At least 8 years applicable experience in the pharmaceutical industry, prior FDA experience is a plus and a Ph.D. in Pharmacology and Toxicology, Pharmaceutical Sciences, or closely related discipline (M.S. with significant experience will be considered).
- Knowledge of regulatory guidelines and requirements and experience with nonclinical pharmacology/toxicology strategy development, study design, data interpretation, and risk assessment.
- Experience with the preparation of regulatory documents (e.g., IBs, Briefing Packages, INDs, CTAs, NDAs, and MAAs) in eCTD format.
- Experience interacting with the FDA on INDs, NDAs, and development programs; interaction with other regulatory authorities (e.g., EMA, Health Canada, etc.) is a plus.
- Proven track record of business development and client relationship management.
- Knowledge of contract laboratory function and ability to interact with CROs/laboratories to direct programs is a plus.
- Proficiency in Microsoft Office is required.
- Eligible to work in the U.S. without time limitations.