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
