Clinical Scientist/Sr. Clinical Scientist
Clinical | Brisbane, CA | Full Time
Vera Therapeutics is a clinical-stage biotechnology company focused on developing treatments for immunological and Inflammatory diseases that improve patients’ lives. We seek a highly skilled and motivated Clinical Scientist/Sr Clinical Scientist (non-MD) to join our fast-paced and collaborative team. This Clinical Scientist will work on the design, execution, and monitoring of clinical studies within cross-functional teams, as well as assisting with data interpretation and communication to both internal and external stakeholders.
- Contribute to authoring protocols and amendments, clinical study reports, IBs, ICFs, training documents, and other clinical and regulatory documents, in collaboration with the other development functions
- Partner with cross-functional teams to conduct clinical studies, including operational feasibility, data management deliverables, preparation of meeting materials, communication plans, safety and medical monitoring, preparation of status update reports, and study close-out activities.
- Interact with internal and external stakeholders (CRO, study sites, vendors, committees, etc.) in support of clinical study objectives; responds to or triages questions for appropriate escalations.
- Support senior team members with medical monitoring reports, safety reviews, site interactions, and reviewing TFLs. Identify and evaluate study data trends, outliers, protocol violators, etc. and working with others to develop and communicate relevant medical inquiries.
- Writes sections of HA meeting packages and responds to HA inquiries
- May be responsible for analytical support of clinical trial data (safety and efficacy), including gathering, analyzing, reviewing, interpreting, and providing preliminary assessments and recommendations. Assist in communicating a clear overview of trial results.
- Provide organizational support for data review committees including operationalizing the charter, preparing updates and data reviews, execution of meetings and adjudications, and communication of synthesized data reports.
- Assemble abstracts, posters, content for scientific meetings, conferences, advisory meetings, other events and presentations, and other publicly distributed materials as well as coordinating reviews with internal partners and stakeholders. Ensures timely coordination of submissions to scientific meetings and/or other appropriate venues or groups.
- Conduct literature reviews as needed.
- Responds to questions from other internal and external parties, including investors and analysts, regarding studies and programs
Master/PhD degree, PharmD, or other relevant advanced degree in a health science field, with at least 2 years of experience at a pharmaceutical, CRO or biotechnology company as a clinical scientist or related role required.
- Experience in nephrology, infectious disease (virology), or rheumatology related clinical indications. Mid to late-stage drug development experience highly desirable.
- Experience with data analysis and interpretation required. Ability to review information and/or raw data and synthesize/present into key trends or takeaways.
- Ability to think strategically, innovatively, and tactically with an interest in clinical research and drug development.
- Ability to work in a small/mid-sized company within a largely virtual environment; small biotech/pharma experience preferred. A willingness to work in a fast-paced start up environment.
- Demonstrated ability to evaluate, interpret and present complex clinical data to inform scientific hypotheses and development strategy. Working knowledge of biostatistics, GCP, and regulatory requirements for clinical studies.
- Strong communication skills, both written and verbal, with a proven track record working with and presenting to the executive management team, board members and external thought leaders.
- Demonstrated ability working in a fast-paced cross functional team.
- Ability to handle multiple projects at a time and have strong attention to detail while understanding the higher-level strategy.
- Excellent interpersonal, verbal, and written communication skills.
- Ability to make independent, timely and appropriate decisions.
Vera Therapeutics Inc. is an equal opportunity employer