3 Preclinical Development Jobs

PopVax, an Indian biotechnology company based in Hyderabad, with a primarily remote US subsidiary nominally located in New York, is seeking a senior regulatory executive. The company is funded through research agreements with the Gates Foundation and Vitalik Buterin's biosecurity company, Balvi. Over the past year, PopVax has been developing a novel second-generation mRNA platform for low-cost broadly-protective vaccines using computationally-driven antigen design. The primary focus is on an open-source booster vaccine candidate designed to provide protection against the entire sarbecovirus species and potentially the betacoronavirus genus, including current and future strains of SARS-CoV-2, the virus responsible for COVID-19. Clinical trials for this candidate are planned to commence later this year. The ideal candidate for this role should possess deep expertise in the end-to-end qualification of novel vaccines and biologics in the US, navigating FDA processes from preclinical development to animal trials, GMP manufacturing, human trials (IND), and licensure (BLA). Additionally, experience with regulatory processes in other stringent regimes such as the European Union (EMA), Canada (Health Canada), the UK (MHRA), and Japan (PMDA) is highly desirable. The candidate should be comfortable working independently in a fast-paced environment without immediate support from a regulatory team or junior regulatory executives. Previous experience in regulatory work for a successfully-authorized COVID-19 vaccine in any of these countries would be a significant advantage. The position offers the flexibility to work remotely from any country worldwide (except those sanctioned by the US in ways detrimental to the role). PopVax provides competitive compensation, comprehensive health insurance covering immediate family members (including pre-existing conditions), and a collaborative work environment dedicated to addressing the cutting-edge multidisciplinary challenges associated with the novel mRNA platform.,

As a Principal Biostatistician (Non-Clinical Statistician) at Syneos Health, you will play a crucial role in collaborating with field experts in Research and Pre-Clinical Development. Your primary responsibilities will involve planning, executing, and analyzing relevant experiments independently. This includes designing experiments feasible under given lab conditions, supporting sample-size calculations, and applying for animal testing licenses. You will also be responsible for randomization, transferring data into appropriate statistical software, and interpreting results. In this role, you will take statistical responsibility for one or more standard experiments. You will develop the statistical analysis plan for experiments as appropriate, ensuring consistency within and between projects. Additionally, you will facilitate the organization and coordination of statistical activities for specific experiments and small projects. Leading virtual cross-functional sub-teams within NCS/SIS of DS&AI will be part of your responsibilities. As a Principal Biostatistician, you will oversee the production and accuracy of statistical deliverables and interpretation of results. Working independently on routine and complex statistical questions and tasks, you will develop and implement standard processes for analyzing routine experiments. Moreover, you will ensure the accurate and timely delivery of statistical work outsourced to external providers. Syneos Health is committed to developing its employees through career progression, supportive line management, technical and therapeutic area training, peer recognition, and a total rewards program. The company's Total Self culture allows you to authentically be yourself, fostering a global environment where everyone feels they belong. Syneos Health values diversity of thoughts, backgrounds, cultures, and perspectives to create an inclusive and innovative workplace. Join Syneos Health and be part of a dynamic team that is passionate about accelerating the delivery of therapies to change lives. With a focus on customer success and patient-centricity, you will collaborate with dedicated problem solvers to help customers achieve their goals. Discover the impact of working with a global organization that has been involved in significant drug development milestones over the past five years. Challenge the status quo and take the initiative in a competitive and ever-changing environment at Syneos Health. Learn more about us at http://www.syneoshealth.com.,

Role & responsibilities Support Preclinical Development Strategy Assist in devising and implementing preclinical development strategies for new drugs or generics, including literature review and assimilation of relevant scientific data. Contribute to the design and planning of in vivo and in vitro studies, ensuring alignment with regulatory and therapeutic goals. Study Management and Oversight: Coordinate and support the execution of pharmacodynamics, pharmacokinetics, and toxicological studies, often at contract research organizations (CROs). Verify test article characterization data and review preclinical study protocols, data, and reports for accuracy and compliance. Ensure timely execution of studies in collaboration with CROs and internal teams, maintaining data integrity and regulatory compliance. Data Analysis and Interpretation Compile, analyze, and interpret preclinical data, including statistical analysis of biological results. Prepare study findings for internal discussions, decision-making, and regulatory submissions. Present results in team meetings and contribute to technical reports, study summaries, and presentations. Regulatory Support Review and prepare documentation for regulatory submissions (e.g., IND, NDA, BLA), ensuring all preclinical data meet regulatory requirements. Address and resolve regulatory queries related to pharmacokinetics, efficacy, or toxicity by providing scientific justifications and literature support. CRO and Vendor Management Participate in the identification, selection, and management of CROs for preclinical studies. Set up contracts, handle shipments, and oversee administrative tasks related to external service providers. Cross-functional Collaboration Collaborate with internal and external stakeholders, including discovery research, clinical pharmacology, and regulatory affairs, to ensure seamless project progression. Contribute to the overall translational research strategy and integrate preclinical insights into broader project decisions. Documentation and Compliance Ensure that all work is conducted in a safe, ethical, and compliant manner, adhering to Good Laboratory Practice (GLP) and other relevant standards Preferred candidate profile Perks and benefits