Executive Director, Pharmacovigilance
Structure Therapeutics
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 Executive Medical Director in Pharmacovigilance (PV) at Structure Therapeutics will be responsible for providing scientific and risk management expertise in support Structure’s development compound(s). This position holds the primary responsibility for medical review of individual case safety reports which include confirmation of MedDRA coding, assessments (seriousness and expectedness), case queries, and analysis of similar events as needed. The position will also function as an interdepartmental project lead in the handling and analyses of safety data from clinical trial data and literature reports. The Safety Physician is a key contributor working closely with both internal and external Safety staff, as well as with cross-functional teams such as Clinical Development, Clinical Operations, Biometrics, Medical Writing, Regulatory Affairs, and other multi-disciplinary teams and committees contributing to signal detection and to the risk evaluation and management of safety data.
- 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
- Provides medical reviews for SAEs, SUSARs, and other Safety reports to include case assessments and input to Analysis of Similar Events as required.
- Oversees the Safety Review Committee in collaboration with internal and external cross-functional teams.
- Participates in the presentation and discussion of safety data at Data Safety Monitoring Board meetings.
- Contributes to the preparation and review of the safety sections of the Drug Safety Update Reports (DSURs), Investigator Brochure (IB)/Reference Safety Information, clinical trial protocols and final reports, the informed consent form (ICF), and safety reporting forms.
- Contributes to the development and/or reviews of SOPs.
- Leads and/or supports signal detection and literature review activities.
- Contributes to regulatory submission documents, interactions with global regulatory agencies and/or external stakeholders, and health authority requests.
- Participates in the MedDRA coding review of reported (non-serious) adverse events.
- Ensure patient safety while adhering to the highest quality and ethical standards.
REQUIREMENTS
Education
- A medical degree (MD or equivalent) required.
Experience
- 5-7+ years of medical safety experience (Safety Science/Risk Management) gained in Pharmacovigilance, Clinical Research, or Clinical Development within the Pharmaceutical industry.
- Experience operating in a global pharmacovigilance organization strongly preferred.
- ICSR Medical Review experience including knowledge of MedDRA and WHO Drug coding dictionaries.
- Extensive signal detection/risk management experience with knowledge of biostatistical methods used in drug development and Safety surveillance, analysis and reporting.
- Working knowledge of ICH, US and worldwide Safety reporting regulations and requirements.
- Expertise in or exposure to therapeutic areas (Hepatology and/or Endocrinology) is a plus but not required.
- Strong organizational, project management, and leadership skills.
- Excellent written and verbal communication skills.
- Ability to work in the SF office 3 days a week preferred.
Travel - 20%
The target salary range for this full-time role is Non MD $296,000 - $374,000 and MD $335,000 to $400,000 + 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.