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

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 protocol development, data analysis, and interpretation, to generate robust evidence supporting medical countermeasure efficacy and safety.
• Prepare and review regulatory documents, including Investigational New Drug (IND) applications, Investigational Medicinal Product Dossier (IMPD), Biologic License Applications (BLA), and New Drug Applications (NDA), ensuring compliance with FDA regulations and guidelines.
• Act as a scientific expert during interactions with regulatory agencies, providing guidance on FDA Animal Rule and medical countermeasure development strategies.
• Stay up-to-date with emerging scientific advancements, regulatory changes, and best practices related to FDA Animal Rule and medical countermeasure development.
• Provide technical training and mentorship to junior scientists, consultants and colleagues involved in product development activities.
• Foster collaborations with external research organizations, key opinion leaders, and academic institutions to leverage expertise and advance medical countermeasure development programs.
• Serve as a technical subject matter expert, author, and/or reviewer on non-dilutive funding proposals and programs
• Interface and manage relevant domain activities as a part of large and complex federally funded programs.

Business & Operational:

• Develop, propose, and manage projects for a diverse clientele base in a virtual, team-based working environment.
• Assist in sales, marketing, and business development activities relevant to your area of operation and expertise.
• Maintain appropriate utilization and operational efficiencies to ensure appropriate profitability of relevant domain.

• PhD in a relevant scientific field (e.g., pharmaceutical sciences, immunology, microbiology, virology). DVM and/or MD with relevant career experience also welcome.
• Minimum of 15 years of experience in the pharmaceutical or biotechnology industry, with a focus on product development and regulatory affairs.
• Minimum 5 years of experience working on Federally funded (DOD and/or HHS) product development programs and contracts.
• Proven expertise in the FDA Animal Rule and medical countermeasure development, including a thorough understanding of the regulatory requirements and challenges.
• Extensive experience designing and conducting preclinical studies and clinical trials, with a particular emphasis on animal models and animal ethics considerations.
• In-depth knowledge of Good Laboratory Practices (GLP) and Good Clinical Practices (GCP), and a strong understanding of FDA regulations and guidelines.
• Strong working knowledge of Pharmacokinetic / Pharmacodynamic (PK/PD) modeling, including applied comparative medicine and translational research concepts.
• Demonstrated track record of successful interactions with regulatory agencies, including FDA, and a thorough understanding of the regulatory submissions process.
• Strong analytical and problem-solving skills, with the ability to critically evaluate scientific literature, interpret data, and make data-driven decisions.
• Excellent written and verbal communication skills, with the ability to effectively communicate complex scientific concepts to both technical and non-technical stakeholders.
• Proven ability to work effectively in cross-functional teams and lead multidisciplinary projects.
• Strong organizational skills and ability to prioritize and manage multiple projects simultaneously.

Compensation & Benefits

• Competitive Salary
• Incentive Bonus Plan
• Safe Harbor 401(k) Plan and Matching Contribution
• Paid Vacation, Holidays and Sick Leave
• Medical Insurance
• Short- and Long-Term Disability Insurance
• Life Insurance

Our Commitment to Diversity

Latham BioPharm Group believes in a diverse environment and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion, or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Latham BioPharm Group will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Sia Partners is an equal opportunity employer. All aspects of employment, including hiring, promotion, remuneration, or discipline, are based solely on performance, competence, conduct, or business needs.