7 Preclinical Development Jobs

PopVax is an Indian full-stack biotech building first-in-class and best-in-class vaccines and cancer immunotherapies using machine learning-driven design and relentless empiricism. We design, develop, and manufacture our own RNA medicines end-to-end because we believe great pharmaceutical science can only flourish in tight feedback loops that iterate rapidly. PopVax's experimental work and clinical dose production is based at the RNA Foundry, our integrated R&D and GMP-capable clinical dose production facility in Hyderabad. PopVax's north star is our goal of developing novel vaccines and therapeutics over the next decade with the cumulative ability to save 1 million lives each year the Milli...

As a senior regulatory executive at PopVax, your role will involve overseeing the end-to-end qualification of novel vaccines and biologics in the US through FDA processes. This includes managing the entire process from preclinical development to animal trials, GMP manufacturing, human trials (IND), and licensure (BLA). Your expertise in navigating the regulatory landscape will be crucial in ensuring successful approval and market entry for our innovative medicines. Key Responsibilities: - Lead the regulatory strategy and submission process for novel vaccines and biologics in the US, ensuring compliance with FDA requirements at every stage of development. - Collaborate with cross-functional t...

As a Principal Biostatistician (Non-Clinical Statistician) at Syneos Health, you will play a key role in collaborating with field experts in Research and Pre-Clinical Development to plan, execute, and analyze relevant experiments independently. Your responsibilities will include: - Designing experiments feasible under given lab conditions - Supporting sample-size calculations and application for animal testing licenses - Implementing randomization - Transferring data into appropriate statistics software - Interpreting results - Taking statistical responsibility for one or more standard experiments - Developing the statistical analysis plan for experiments - Facilitating organization and coor...

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 responsibilities will include planning, executing, and analyzing experiments independently. This involves designing experiments feasible under given lab conditions, supporting sample-size calculations, applying for animal testing licenses, randomization, transferring data into appropriate statistical software, and interpreting results. You will take statistical responsibility for one or more standard experiments and develop the statistical analysis plan for the experiments, ensuring overall consistency wit...

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,...

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 stati...

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 executi...