Clinical Development, MD

We are looking for an experienced Clinical MD to manage and oversee our clinical development plan and the medical aspects of advanced-stage clinical trials. In this role, the Clinical MD will address medical inquiries throughout the trial process, contribute to protocol development, and participate in ongoing trial monitoring, including preparing Clinical Study Reports (CSR).

Additionally, the Clinical MD will work closely with internal and external stakeholders to shape the clinical strategy, helping to define the optimal trial path and medical indications required for FDA approval.

Key Responsibilities
Provide medical consultation and support throughout advanced clinical trials, demonstrating a deep understanding of the clinical research process.
Contribute to developing clinical trial protocols, ensuring scientific accuracy and full regulatory compliance.
Oversee the execution of clinical studies, including process monitoring and preparation of Clinical Study Reports (CSRs) summarizing key findings.
Participate in defining the optimal types of trials and clinical indications to support a strong case for FDA approval.
Manage and support the execution of complex clinical programs, including multiple concurrent trials designed to generate comprehensive and robust data.
Supervise small-scale pharmacological studies focusing on pharmacokinetic (PK) and pharmacodynamic (PD) parameters.
Lead preparations for regulatory meetings (e.g., IND), including analysis and interpretation of preclinical pharmacology and PK/PD data.
Define clinical trial objectives and endpoints as part of the overall strategy, ensuring alignment with both medical standards and regulatory expectations.