Sr. Medical Director
Structure Therapeutics
Structure Therapeutics develops life‐changing medicines for patients using advanced structure‐based and computational drug discovery technology. The company’s platform combines the latest advancements in visualization of molecular interactions, computational chemistry, and data integration to design orally available, superior small molecule medicines that overcome current limitations of biologic and peptide drugs. We are advancing a clinical‐stage pipeline of differentiated treatments focused on chronic diseases with high unmet need, including cardiovascular, metabolic, and pulmonary conditions.
Structure Therapeutics is led by an experienced group of international drug innovators and financed by top-tier global life sciences investors. The company has completed an initial public offering (IPO) in February of 2023. With offices in California and Shanghai, Structure Therapeutics has the benefit of being at the center of life science innovation in both the US and China and capitalizing on the strengths of each geographic location.
POSITION SUMMARY
The Senior Medical Director at Structure Therapeutics will provide medical support on clinical drug development of the assigned compound(s), including being a key driver of medical monitoring governance across portfolio programs, assisting in developing a clinical development strategies and plans, and all related activities. These activities may include, but are not limited to, leading medical monitoring oversight across lead development programs, assist in study design and conduct, participation in key regulatory interactions and document preparation (IND and NDA), and work with medical lead to communicate with health authorities and medical societies during the drug development process. This is a hybrid role that will require 3 days in the office (2 core days and 1 flex day). We are moving to 4 days a week in the near future. #LIHybrid
ESSENTIAL DUTIES AND 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 represents 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
- Assist 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.
- Other duties as assigned
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
- Travel requirements as needed
Communication & Interpersonal Skills
- 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
REQUIREMENTS
Education
- A medical degree (MD or equivalent) with clinical experience in obesity & type 2 diabetes or related area (s) preferred
Experience
- 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
- Experience in preparation and submission of clinical trial documents and/or new drug applications is advantageous
Travel - 20%
The target salary range for this full-time role is $315,000 - $378,000 + bonus + equity + benefits. Structure Therapeutics determines salary ranges based on level and scope of responsibilities, as well as location. Individual pay is further determined by additional factors, including relevant experience, specific job skills, education and training. More details about the specific salary range for your location will be discussed with you during the hiring process by the StructureTx Talent Acquisition Team.