Senior/Principal Consultant - FDA Animal Rule and Medical Countermeasure Specialist

Company Description

Latham BioPharm Group

Latham BioPharm Group, a part of Sia Partners, provides the insight, knowledge, and network to unite teams and technologies in the Life Sciences. We provide the depth of expertise necessary to advance programs, by providing a range of life science services including business development, program management, CMC, non-clinical, quality, regulatory, and strategic consulting with proven experience in biodefense/pandemic response and strategic product development.

At LBG, we have established corporate principles which help define who we are as a group and are used as guidelines for how we work, make decisions and interact with each other and our stakeholders.

• We enjoy coming to work
  • The work we do is interesting and fun
  • We enjoy interacting with the people we work with
  • Everyone’s input and contribution is valued
  • We work together as a team
• We are making a significant positive difference in the world
• We maintain the highest level of integrity
• We are building a sustainable entity where we and others can enjoy working under these principle

Sia Partners

Sia Partners is a next-generation consulting firm dedicated to creating state-of-the-art narratives for transformation and innovation and deploying them at scale. Our goal is to deliver superior value and tangible results to our clients as they navigate the digital revolution and achieve transformations which generate a positive impact. Our global footprint and expertise in more than 40 sectors and services allow us to enhance our clients’ businesses worldwide. We guide their projects and initiatives in strategy, business transformation, IT & digital strategy, and Data Science. 

Why join the Sia Village? 

Excellence | Entrepreneurship | Innovation | Teamwork | Care & Support | Employee Wellbeing

These are the six core values that guide all our actions. As an expression of our values, our Sia Village concept describes our commitment to fostering a sense of community within and among our offices. We believe that knowledge sharing is the key, not only to innovation, but to the growth and development of our people.

Your experience at Sia Partners will be enriched by a(n):  

• Entrepreneurial journey
• Career advocacy program that supports achieving professional development goals through guidance, and real-time feedback
• Continuous learning & development opportunities
• Diversity, equity, and inclusion programs with an ever-growing list of global affinity initiatives
• Annual seminar, an in-person value-add experience, that allows you to network with colleagues throughout North America

Job Description

Latham Biopharm Group is a leading life science research and development consulting organization dedicated to assisting our clients to discover and develop countermeasures to chemical, biological, radiological, and nuclear (CBRN) threats and beyond. We are committed to developing medical countermeasures in compliance with regulatory guidelines and ensuring the safety and efficacy of all products destined to treat and prevent disease. As we expand our portfolio, we are seeking a highly experienced and capable professional with expertise in the FDA Animal Rule and Medical Countermeasure development to join our team.

We are looking for a driven career professional who specializes in product development via the FDA Animal Rule and has a deep understanding of the development of defense and public health medical countermeasures. The successful candidate will play a pivotal role in leading and supporting the development, registration, and post-approval activities of pharmaceutical, diagnostic, and devices designed to address public health and national security threats. As a subject matter expert, you will collaborate cross-functionally with internal teams and external stakeholders to ensure compliance with regulatory requirements and successful product development.

Responsibilities:

Technical & Scientific:

• Provide scientific leadership and expertise in FDA Animal Rule-based development programs, including the design and execution of preclinical studies and clinical trials involving animal models.
• Conduct thorough literature reviews and analyze scientific data to identify knowledge gaps and develop strategies for successful medical countermeasure development.
• Collaborate with cross-functional teams, including regulatory affairs, toxicology, pharmacology, clinical development, and quality assurance, to develop and execute comprehensive drug development plans.
• Design and oversee preclinical studies, including animal model selection, study