Senior Medical Director
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.
- Preference is for local candidates, and we are moving to a 4-day work week / in the SSF QC office
- If remote, you will be required to work in SSF QC office one week a month
Essential Duties And Responsibilities
Provide medical oversight for the effective conduct of clinical trials, including :Medical monitoring on clinical development programsCollaboration with other functional areas to participate in design and governance of clinical development plans and study protocolsMonitor and review medical data for all clinical trials and represents the sponsor in internal Safety Review CommitteesEngage with clinical investigators and study site personnelAnalyze, present, and interpret data from clinical studiesParticipate with clinical team on global clinical strategy and clinical development plan for assigned projectsMaintain current scientific knowledge in relevant therapeutic areas and therapeutic mechanisms through review of scientific literature and attendance at relevant scientific meetingsParticipate 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 requiredParticipation in updating key documentation (IB, DSUR, etc.)Represent Structure Tx in external engagement-related activities :Manage interactions with investigators to address medical and scientific questionsAssist in publishing data in appropriate peer-reviewed platforms with abstract / poster, presentations, and manuscriptsCollaborate actively with cross functional teams, such as Pharmacovigilance, Regulatory Affairs, Clinical Operations, Data Management, Biostatistics etc.Other duties as assignedCore Competencies, Knowledge, and Skill Requirements
Knowledge of study design, protocol development and study conductExcellent written and oral communication skills in the negotiation, presentation, and authoring process with relevant cross function team and medical expertsSufficient knowledge of business processes, regulatory, and compliance related to drug developmentTravel requirements as neededCommunication & Interpersonal Skills
Excellent verbal and written communication skillsAbility to effectively collaborate in a dynamic environmentCompetency in decision making, influencing, and execution in a changing business environmentComfortable with uncertainties through excellent risk management skillRequirements
Education
A medical degree (MD or equivalent) with clinical experience in obesity & type 2 diabetes or related areas preferredExperience
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 stageExperience in preparation and submission of clinical trial documents and / or new drug applications is advantageousTravel - 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.