Medical Director

Structure Therapeutics•South San Francisco, CA

8d•Hybrid

About The Position

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 completed an initial public offering (IPO) in February 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. The Medical Director 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 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, participating in key regulatory interactions and document preparation (IND and NDA), and work with the medical lead to communicate with health authorities and medical societies during the drug development process.

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
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.

Nice To Haves

Experience in preparation and submission of clinical trial documents and/or new drug applications is advantageous

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.