VP, Programs Team Lead - Early 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 VP, Programs Team Lead (PT Lead) early development will be responsible for strategic development of program leadership and clinical/medical oversight of relevant drug candidates within the Structure therapeutics portfolio in metabolism, including providing guidance on potential therapeutic targets, development strategies and oversight of clinical development programs intended to support registration in selected geographies. Strong clinical, scientific and pharmaceutical development experience is required, along with excellent communication skills and organizational leadership experience. Clinical development experience across geographies, including US and China is strongly preferred. This individual will report to the CMO and have direct reports. For local candidates, this is a hybrid role that will require 3 days in the office (2 core days, 1 flex day).  We are moving to 4 days/week in the office. If remote, you will be required to work in the SSF office one week/month. #LIHybrid  

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Lead the strategic planning, oversight and management of the assigned clinical program(s) from an end-to-end clinical development perspective, with a focus on early development (from first in human to phase 2 development)
• In collaboration with Program Management, lead the program towards efficiencies, including timelines, budget and resources
• In collaboration with preclinical functions, lead the initial first in human clinical studies
• Provide clinical leadership and strategic medical input for all clinical deliverables in the assigned project
• Oversee the development of clinical sections of trial and program level regulatory documents
• Lead the preparation of the global Clinical Development Plan (CDP) and Clinical Trial Protocols for assigned product candidates
• Interact with health authorities on assigned projects
• Collaborate actively across functions, including drug safety, toxicology, pre-clinical, regulatory, clinical operations, data management, statistical analysis, program management, etc.
• Evaluate opportunities and plans on assigned molecules for the development of new indications

Study-related responsibilities

• In collaboration with Clinical Operations, drive execution of the clinical development plan for assigned programs
• With Pharmacovigilance, oversee the safety of assigned drug candidates, and may act as a member of the Safety Review Committee (SRC)
• Oversee the monitoring and review of medical data for clinical trials
• Analyze, interpret and present the data from clinical studies

Corporate-related responsibilities

• Lead the Product Team Meetings (cross functional strategic team) for the early development Metabolism-related programs at Structure Therapeutics
• Manage the group of medical monitors and clinical scientists assigned to the metabolic portfolio
• Participate and support the research, in/out licensing of new targets or drugs in related areas led by business development and/or preclinical research team

External facing

• Organize and run Scientific Advisory Boards for assigned product candidates
• Publish data in appropriate peer-reviewed platforms with abstract, posters, and both presentation and manuscripts
• Interact with external experts from health authorities and/or academic institutions (e.g., Center of Drug Evaluation, US FDA, Advisory Committee, Key Opinion Leaders) as appropriate

REQUIREMENTS

Education

• A medical degree (MD or equivalent) or PhD with clinical development experience in metabolism

Experience

• At least 10 years plus experience of clinical drug development in pharmaceuticals/biotech industry, including designing and implementation of clinical trials in early/late stage
• Experience of preparation and implementation for clinical trial application and/or new drug application
• Managerial experience of medical team preferred
• Good written and oral communication skills in English in the negotiation, presentation, and authoring process with relevant cross function team, medical experts, as well as regulatory reviewers 
• Sufficient knowledge of business process, regulatory, and compliance related to drug development

Travel – ~25%

The target salary range for this full-time role is $344,000 - $413,000 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.