Senior Medical Director
Structure Therapeutics · South San Francisco, CA · 1 mo ago
On-siteHealthcare$324k–$409k/yrFull-time
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
- 3-5+ 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