Associate Director, Clinical Development Medical Director (MD Required)

Role Summary

Associate Director, Clinical Development Medical Director (MD Required). The role ensures medical and scientific integrity of clinical trials, designs efficient, high-quality trials, and supports data interpretation and communication. Responsible for execution of studies in collaboration with clinical teams, maintaining compliance, mitigating risk, and potentially performing medical monitoring. Acts as primary contact for external investigators and internal teams on protocol-related clinical/medical aspects and supports disease area strategy.

Responsibilities

• Performs medical monitoring on one or more clinical trials, including addressing medical questions, safety findings, serious adverse events, audits/inspections, and contributing to quality assessments.
• Conducts and documents periodic safety data reviews and ongoing clinical/medical data reviews; reviews safety text and endorses significant changes in informed consent documents.
• Provides clinical/medical input to protocol design and leads or supports protocol development to maximize operational efficiency, trial quality, and site engagement.
• Leads or supports protocol amendments, changes to communications with investigators, and data collection tool development; provides input to SAP, TLFs, and BDR.
• Authorizes and manages approval of Informed Consent Documents; contributes to IQMP and risk management plans; establishes Data Monitoring Committees and endpoint adjudication processes.
• Ensures activities align with approved plans; collaborates with stakeholders to implement risk mitigations; participates in site selection and training material delivery.
• Serves as primary contact for external investigators and internal study teams on clinical/medical aspects; reviews protocol deviations and patient-level data per data review plans.
• Tracks SAEs, ensures TMF compliance, supports Clinical Study Reports and dissemination of safety/efficacy data; may contribute to regulatory filings and CTAs as needed.
• Contributes to continuous improvement and innovative approaches to trial execution.

Qualifications

• Required: Medical degree (MD/DO/MBBS/MBChB) with clinical research experience; licensed to prescribe medicines; in good standing with Medical Licensing Authority; clinical research experience in phase 3/pivotal space; strong scientific writing skills.
• Preferred: Industry/CRO clinical research experience; cardiometabolic disease experience; extensive knowledge of clinical development, global/regional regulation, ICH/GCP, adverse event management; excellent communication skills in English; demonstrated leadership and project management capabilities.