Pre-Clinical Studies: Supporting CSO and Preclinical staff for IND and CTA readiness activities including but not limited to in vitro and in vivo studies to assess the safety, toxicity, and pharmacokinetic profiles of drug candidates.

Regulatory Documentation: Preparing Investigational New Drug (IND) applications or equivalent submissions to regulatory authorities, including comprehensive pre-clinical data.

Biomarker Identification: Identifying and validating biomarkers that can be used to measure drug effects and predict clinical outcomes.

First-in-Human Trials: Designing and conducting first-in-human (FIH) studies to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of the drug in healthy volunteers or patients.

Dose Escalation: Implementing dose-escalation studies to determine the maximum tolerated dose (MTD) and establish the recommended dose for further studies.

Safety Monitoring: Establishing rigorous safety monitoring procedures, including Data Safety Monitoring Boards (DSMBs) and safety governance to ensure participant safety during early trials.

Regulatory and Ethics and Approvals: Obtaining necessary Regulatory ethical approvals and scientific advices such as briefing books

Study Design and Protocol Development: Collaborating with pre-clinical scientists, regulatory affairs, and otherdepartments to ensure a seamless transition from pre-clinical to clinical development.

Stakeholder Engagement: Communicating study progress and findings to internal and external stakeholders, including regulatory bodies and scientific communities.

Risk Identification and Mitigation: Identifying potential risks associated with early-stage development and implementing strategies to mitigate these risks..