Director, Clinical Development Medical Director (MD Required)

Role Summary

The Director, Clinical Development Medical Director (MD Required) is responsible for the medical and scientific integrity of clinical trials, ensuring high-quality design and operational excellence, and overseeing medical monitoring and data interpretation. The role involves collaboration with clinical/medical colleagues, clinical operations, and other functions, with accountability for timely delivery of quality protocols and study execution. The position may include matrix management of R&D Internal Medicine clinicians and requires MD-level qualifications and license.

Responsibilities

• Performs medical monitoring on one or more clinical trials
• Provides study-related medical information and assistance on investigators, site personnel, safety findings, audits, and quality assessments
• Contributes to final quality event medical assessments and conducts periodic safety data reviews
• Reviews safety text and endorses significant medical changes in informed consent documents
• Leads clinical execution of studies of medium-high complexity and may be accountable for program-level deliverables
• Provides input to protocol design, leads protocol development for operational efficiency and engagement
• Leads protocol amendments and related letters; provides data collection tool input
• Authors and approves informed consent documents; contributes to IQMP development
• Establishes Data Monitoring Committees and endpoint adjudication committees; manages risk and safety plans
• Reviews country/site selection, training materials, and protocol deviations
• Acts as primary contact for protocol-related medical questions with external investigators
• Reviews patient-level and cumulative data; tracks SAEs and presents data in Safety Review Team meetings
• Serves as medical monitor; ensures TMF compliance
• Inputs to and reviews Clinical Study Reports; supports safety/efficacy disclosures and primary publications
• Supports audits/inspections and regulatory filings as needed; contributes to continuous improvement in trial execution

Qualifications

• Obtained a primary medical degree (MD, DO, MBBS, MBChB) and minimum 4 years of Clinical Development experience in industry/CRO
• Licensed to prescribe medicines independently for at least 2 years post internship/foundation
• Medical license maintained in good standing
• Clinical research experience in phase 3/pivotal space
• Strong scientific writing skills; publications, posters, abstracts, or presentations
• Extensive knowledge of clinical development, global/regional regulation, ICH/GCP, adverse event management
• Excellent verbal and written communication in English; experience leading teams in clinical development

Skills

• Medical monitoring and data interpretation
• Protocol design and amendments with a focus on operational efficiency
• Risk management and safety oversight
• Cross-functional collaboration and stakeholder management
• Regulatory knowledge and regulatory filing support (as needed)

Education

• Primary medical degree from a recognized medical school/university

Additional Requirements

• Global travel may be required
• Hybrid work arrangement: on-site ~2.5 days/week within commuting distance