- Assist with the strategy and creation of the clinical development plans for one or more programs.
- Contribute to key strategic documents including clinical development plans, protocol concepts and full protocols for product(s).
- Contribute to the development of clinical sections of regulatory documents such as Investigators' Brochures, briefing books, safety updates, IND/NDA submission documents, responses to Health Authorities questions.
- Review and summarize relevant literature on the clinical development programs.
- Support investigator meetings and protocol training meetings.
- Maintain current knowledge of the external environment to ensure scientific innovations are considered and/or incorporated into clinical trial development strategy.
- Support the medical monitoring-related activities, including data collection, data review and insight generation.
- Support authoring/reviewing abstracts, presentations, and manuscripts for external publications.
- The Clinical Scientist is responsible for supporting and/or performing ongoing clinical data review during study execution to ensure integrity of accruing study data and appropriate safety follow-up.
- Analyze and interpret study data from an individual study and translate study level clinical data across the program of studies.
- Ensure that all studies are conducted with the highest level of ethical and safety standards in compliance with GCP and all regulatory policies.
- Serve as one of the primary contacts for site-facing activities such as training and support for clinical questions.
- Conduct and oversee activities related to data generation and validation, including CRF design, and clinical data review/query resolution; ensure consistent, quality data review, protocol deviation review, and coding review.
- Identify clinical data trends; provide trends and escalate questions to Medical Monitor
- Coordinate the real time availability of quality clinical trial data, including safety, efficacy, pharmacokinetic and biomarker data, to provide consolidated information for dose escalation meetings and data reviews with investigators.
- Author/review clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., pre-IND, IND, IB, DSUR, BLA, PSP, regulatory responses)
- Author/review abstracts, presentations, and manuscripts for external publications
- Partner with Data Management to develop electronic CRF and instructions for use, the Data Quality Review Plan, and resolution of all clinical queries to sites.
- Collaborate with Biostatistics to develop and QC data tables, listings, and figures and develop data-driven study-specific analyses, as appropriate.
- Collaborate with Safety Science to identify and track any potential safety events within a given trial and/or across trials for assigned program(s)
- Conduct medical data reviews.
- Provide Clinical Science input to proposed revisions of SOPs and Guidance documents.
- Provide support to prepare presentations for advisory boards, steering committee meetings, consultant meetings and investigator meetings.
- Proactively seeking out and recommending process improvements.
- Provide scientific input to the preclinical team for translational studies of interest including biomarker development strategies.
- Master's Degree, PhD or PharmD with at least 2-3+ years clinical trial/drug development experience.
- The ideal candidate will have at least 2-3+ years technical and operational experience in planning, executing, reporting, and publishing clinical studies in a pharmaceutical company and/or contract research organization.
- Proficient with software tools (Microsoft Office Suite), Adobe, SharePoint, Share Drive, and other custom web-based software used data analysis and data visualization (i.e. Spotfire, Tableau etc.)
- Experience authoring new study protocols, CRFs, ICFs, Reports, and other applicable study materials for clinical trial use.
- Experience writing Clinical Study Reports (CSR) with a good understanding of clinical trial operations, clinical trial logistics, and Good Clinical Practices.
- Experience operating effectively within a biotech start-up with complex studies; ability to prioritize tasks and manage multiple priorities and meet deadlines.
- Collaborative, team-oriented mindset with strong verbal and written communication skills.
- Self-motivated, detail-oriented leader with exceptional organizational, leadership and interpersonal skills.
- Excellent leadership and project management skills; able to prioritize multiple tasks and goals and deliver them in a timely, on-target, and high-quality manner within budget guidance.
- Excellent interpersonal, verbal communication, and influencing skills; can influence without authority and has proven experience building and cultivating relationships with key partners and stakeholders both internally and externally.
- Strong presentation skills; effective at summarizing and presenting the key considerations and decision-points.
- Excellent teamwork and negotiation skills; able to complete deliverables by working effectively with others internally and externally and can effectively drive discussions and decisions toward desired end-results.
- Proficient in Microsoft Word, Excel, PowerPoint, Electronic Data Capture (e.g., Medidata/RAVE) or similar data reporting tools
- 10-20%
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Clinical Scientist - South San Francisco, United States - Structure Therapeutics Inc
Description
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.
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.#Hybrid.
POSITION SUMMARY
ESSENTIAL DUTIES AND RESPONSIBILITIES
REQUIREMENTS
Education
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.
