Senior Medical Director

Structure Therapeutics Inc.; South San Francisco (CA); On-site; USD 324,000 - 409,000; Full time

Benefits offered by this job

Annual incentive bonus

New hire equity

Equity plan

Medical insurance

Dental insurance

Vision insurance

401k match

Unlimited PTO

Winter shutdown holidays

Job summary

Structure Therapeutics Inc. is seeking a Senior Medical Director to provide medical support on clinical drug development for the assigned compound(s).

You will drive medical monitoring governance, help develop development strategies, and work with health authorities during the drug development process. You will lead medical monitoring oversight across programs, assist in study design, participate in regulatory interactions (IND/NDA), and collaborate with cross-functional teams to ensure

Qualifications

• Medical degree required.
• 3–5+ years of medical monitoring oversight and clinical drug development experience.
• Experience in preparing and submitting clinical trial documents and/or NDAs is advantageous.

Responsibilities

• Provide medical oversight for the effective conduct of clinical trials, including medical monitoring on clinical development programs and governance.
• Collaborate with other functions to design and govern clinical development plans and study protocols.
• Monitor and review medical data across trials and represent the sponsor in Safety Review Committees.
• Engage with clinical investigators and study site personnel.
• Analyze, present, and interpret data from clinical studies.
• Participate in global clinical strategy and development planning for assigned projects.
• Maintain current scientific knowledge through literature reviews and conferences.
• Collaborate with Clinical Team and Regulatory Affairs to interact with Health Authorities and prepare clinical documents.
• Represent Structure Therapeutics in external engagements and support publication of data.
• Collaborate with Pharmacovigilance, Regulatory Affairs, Clinical Operations, Data Management, Biostatistics, etc.

Education

MD or equivalent

Job description

About Us:

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.

Position Summary:

The Senior 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.

Job 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


• 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

Qualifications:

• A medical degree (MD or equivalent) with clinical experience in obesity & type 2 diabetes or related area (s) preferred


• 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, or in a relevant clinical practice setting.


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

Travel Required:

• This role requires periodic travel to company headquarters and to external business meetings, as needed. Travel frequency will vary based on business needs and project requirements.

Structure Therapeutics Inc. is an Equal-Opportunity Employer:

Structure Therapeutics is committed to fair and equitable compensation practices, and we strive to provide employees with total compensation packages that are market competitive. For this role, the anticipated base pay range is $324,000-$409,000. The exact base pay offered for this role will depend on various factors, including but not limited to the candidate’s geography, qualifications, skills, and experience.

The successful candidate will be eligible for an annual performance incentive bonus, new hire equity, and ongoing performance-based equity.

Structure Therapeutics also offers various benefits offerings, including, but not limited to, medical, dental, and vision insurance, 401k match, unlimited PTO, and a number of paid holidays including winter shutdown.

• annual performance incentive bonus


• new hire equity


• ongoing performance-based equity


• medical, dental, and vision insurance


• 401k match


• unlimited PTO


• a number of paid holidays including winter shutdown