structuretx

structuretx

Senior Medical Director

South San Francisco, California · Director

Sponsorship not specified$324k-$409kDetected 20 days ago
NegotiationClinical TrialsFDA RegulatoryPharmacovigilanceExperimental DesignCommunicationCollaborationPublic SpeakingBiostatisticsRegulatory Affairs

About the role

  • Provide medical oversight for the effective conduct of clinical trials, including:
  • Medical monitoring on clinical development programs
  • Monitor and review medical data for all clinical trials and represents the sponsor in internal Safety Review Committees

Responsibilities

  • Collaboration with other functional areas to participate in design and governance of clinical development plans and study protocols
  • Maintain current scientific knowledge in relevant therapeutic areas and therapeutic mechanisms through review of scientific literature and attendance at relevant scientific meetings

Requirements

  • Sufficient knowledge of business processes, regulatory, and compliance related to drug development
  • Travel Required:
  • Preparation of clinical documents, or clinical sections of documents, as required
  • A medical degree (MD or equivalent) with clinical experience in obesity & type 2 diabetes or related area (s) preferred
  • Experience in preparation and submission of clinical trial documents and/or new drug applications is advantageous

Skills

  • Core Competencies, Knowledge, and Skill Requirements:
  • Excellent verbal and written communication skills
  • Comfortable with uncertainties through excellent risk management skill

Compensation

  • For this role, the anticipated base pay range is $324,000-$409,000.

Benefits

  • 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.
  • Participate with Clinical Team and Regulatory Affairs to ensure effective collaboration with global Health Authorities, including:

Company info

  • 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.
  • 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 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.
  • Structure Therapeutics is committed to fair and equitable compensation practices, and we strive to provide employees with total compensation packages that are market competitive.
  • At Structure, base pay is only one part of your total compensation package.

Visa & Work Authorization

  • Monitor and review medical data for all clinical trials and represents the sponsor in internal Safety Review Committees
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