Medical Director

Job Responsibilities

• Provide medical oversight for the effective conduct of clinical trials, including:
• Medical monitoring on clinical development programs
• Collaboration with other functional areas to participate in design and governance of clinical development plans and study protocols
• Monitor and review medical data for all clinical trials and represent the sponsor in internal Safety Review Committees
• Engage with clinical investigators and study site personnel
• Analyze, present, and interpret data from clinical studies
• Participate with clinical team on global clinical strategy and clinical development plan for assigned projects
• Maintain current scientific knowledge in relevant therapeutic areas and therapeutic mechanisms through review of scientific literature and attendance at relevant scientific meetings
• Participate with Clinical Team and Regulatory Affairs to ensure effective collaboration with global Health Authorities, including:
• Preparation of clinical documents, or clinical sections of documents, as required
• Participation in updating key documentation (IB, DSUR, etc.)
• Represent Structure Tx in external engagement-related activities
• Manage interactions with investigators to address medical and scientific questions
• Aid in publishing data in appropriate peer-reviewed platforms with abstract/poster, presentations, and manuscripts
• Collaborate actively with cross functional teams, such as Pharmacovigilance, Regulatory Affairs, Clinical Operations, Data Management, Biostatistics etc.

Core Competencies, Knowledge, And Skill Requirements

• Knowledge of study design, protocol development and study conduct
• Excellent written and oral communication skills in the negotiation, presentation, and authoring process with relevant cross function team and medical experts
• Sufficient knowledge of business processes, regulatory, and compliance related to drug development
• Excellent verbal and written communication skills
• Ability to effectively collaborate in a dynamic environment
• Competency in decision making, influencing, and execution in a changing business environment
• Comfortable with uncertainties through excellent risk management skill

Qualifications

• A medical degree (MD or equivalent) with clinical experience in obesity & type 2 diabetes or related area(s) preferred
• 1-2+ years of experience in medical monitoring oversight and clinical drug development in the pharmaceuticals/biotech industry, including participating in the designing and implementation of clinical projects in early/late stage, or in a relevant clinical practice setting
• Experience in preparation and submission of clinical trial documents and/or new drug applications is advantageous