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

LBG provides a range of technical support and scientific expertise to help advance client programs and achieve successful product development milestones from early-stage nonclinical development through regulatory submission and beyond. This includes providing advisory services for nonclinical product development, toxicology, and due diligence of drugs, biologics, medical devices, and diagnostics.

In this role, you will play a crucial role in supporting client drug development programs and ensuring the safety of their pharmaceutical products. Your expertise will be instrumental in guiding client research and development efforts, development timeline and objectives, and overall product development strategy. Your extensive knowledge of nonclinical safety and toxicological assessments will be leveraged to assess potential risks and ensure regulatory compliance throughout the drug development lifecycle.

In addition, you will support relevant efforts with other LBG services, including but not limited to market research, due diligence, and non-dilutive funding capture and proposals. The ideal candidate must be able to work independently and have excellent interpersonal relationship skills with flexibility to adapt to fast-paced environment with changing priorities.

Responsibilities:

Technical & Scientific:

• Assist with and/or oversee the development and evaluation of comprehensive nonclinical program packages
• Develop and review nonclinical / toxicology study designs and protocols
• Review and evaluate SOPs, raw data, draft, and final reports for nonclinical studies
• Lead relevant nonclinical vendor identification and selection activities
• Serve as a Sponsor Study Monitor for client non-GLP and GLP studies
• Provide nonclinical toxicology support to other LBG stakeholders on cross-functional programs
• Support client regulatory submissions with relevant nonclinical subject matter expertise, including generating content as required
• Provide nonclinical guidance for product market research, due diligence, and technical strategic positioning
• Assist with proposal capture and support proposal production related to nonclinical services
• Provide and/or lead day-to-day support to project teams to deliver on programs and meet target utilization metrics
• Maintain a working knowledge of nonclinical product development regulations (i.e., FDA, ICH, WHO etc.)
• Adhere to LBG quality standards regarding client deliverables and core values
• Support or, where applicable, lead new business efforts as required for both internal and external clients
• Support the creation of internal tools, systems, methods, and materials that help LBG perform more efficiently and with higher quality results
• Short term travel to client and CRO sites as required for study monitoring and audits (approximately 3-4 days per month).

Basic Qualifications:

• Advanced degree (M.S. or PhD) in a Pharmacology, Toxicology, or other related life science discipline with appropriate years of experience:
• PhD with 3+ years’ experience including 2 years minimum experience as a Study Director (general toxicology/PK) in the nonclinical CRO industry
• M.S. with 5+ years’ experience including 4 years minimum experience as a Study Director (general toxicology/PK) in the nonclinical CRO industry
• Direct experience designing and conducting Reproductive Toxicology assessments in accordance with ICH Guidelines
• Demonstrated experience designing and conducting non-GLP and GLP studies via management of cross functional teams including, but not limited to, direct experience in the following activities:
• Protocol/report development/generation and review
• Generation of documentation (paper/electronic) in compliance with all applicable regulations
• Oversight of general study procedures as they pertain to FDA regulations, site-specific procedures, and animal welfare policies
• In-depth knowledge of Good Laboratory Practices (GLP) (21 CFR Part 58)
• General knowledge of operating procedures within the nonclinical CRO industry including, but not limited to, the CRO contracting process, study set-up and initiation, study close-out procedures, and auditing process
• Demonstrated ability to effectively summarize nonclinical studies in written format and ability to evaluate and communicate or present results of nonclinical studies to clients
• General knowledge of current nonclinical guidance from applicable regulatory bodies (i.e., FDA, ICH, WHO, etc.) as they pertain to nonclinical product development
• Ability to lead and support teams of a cross-functional and multi-level nature independently and/or in a group setting in a virtual format
• Strong organizational skills and ability to prioritize and manage technical and administrative aspects of multiple projects simultaneously.
• Proficient computer skills and ability to learn new software and systems with direct experience with Microsoft Office 365
• Demonstrated dedication to customer satisfaction and maintenance of scientific integrity
• Flexible in adjusting priorities and able to take risks to accomplish goals
• Effectiveness and creativity in approaching and solving technical problems

Preferred Qualifications:

• Experience drafting and compiling nonclinical study information for regulatory submissions (e.g. Pre-IND, IND, etc.)
• Demonstrated business development and/or sales experience in the life sciences.
• Experience supporting federally-funded (DOD and/or HHS) product development programs
• Working knowledge of animal health / veterinary product development.

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.