Director, Clinical Development

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 Director, Clinical Development 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.

Essential Duties And Responsibilities

• Provide program oversight for the effective conduct of clinical trials, including:
• Build internal capabilities/ team focused on clinical trial site support
• Site facing engagement plan
• Define and implement key metrics and expectations to ensure flawless clinical trial execution
• Lead the creation and implementation of new initiatives for patient retention
• Enhance participant/site experience
• Aim to identify and implement strategies to position Structure as the “sponsor of choice”
• Review end-to-end interactions with sites to find efficiencies/optimization
• Partner with the team to systematically improve protocol quality
• Bring the patient/site perspective to protocols
• Contribute to initiative to improve protocol compliance and reduce amendments
• 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
• Participate with clinical team on global clinical strategy and clinical development plan for assigned projects.
• 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

• Bachelor’s or master’s with at least 10 years clinical trial/drug development experience.
  
  

Experience

• 10 years in clinical drug development, operation, medical affairs in the pharmaceuticals/biotech industry, and/or clinical setting in a strategic role, 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 $200,000 – $253,000 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.