We are seeking an experienced clinical scientist to successfully strategize and execute a clinical development plan for engineered IgM-based pipeline molecules, starting from First in Human Phase I studies, primarily conducted in the U.S and primarily in Oncology indications.
- Advanced scientific or clinical degree (eg PhD, PharmD, MPH, MD, etc).
- 5 or more years clinical trial experience (must demonstrate a minimum of 2 years clinical trial experience in pharma/biotech industry).
- Data listing review experience is preferred.
- Experience authoring experimental protocols and/or study results and conclusions.
- Relevant therapeutic area experience.
- In-depth understanding of Phase I (and beyond) drug development.
- Experience in the principles and techniques of data analysis, interpretation.
- Sound knowledge of medical aspects of GCP (Good Clinical Practice), ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMEA, NICE and other relevant guidelines and regulations.
- Proven abilities to perform Clinical Scientist responsibilities with increasing expertise and independence.
- Track record of working well with other scientists and clinicians is highly valued.
- Must be able to commute to Mountain View.
- Able to travel (<20%).
- Participate in Development teams, and clinical trial teams.
- Work with Clinical Development, Clinical Operations, Drug Safety, Biostatistics, Regulatory, and Biomarker groups.
- Develop clinical strategies.
- Lead clinical trial protocol development, and amendments.
- Literature research and review in disease/program area.
- Assist with completion and submission of regulatory filings and other regulatory documentation.
- Work with clinical teams on study site visits, and protocol training.
- Contribute to Investigator Meetings, and Investigator/study calls.
- Work with Clinical Operations and Medical Directors to develop consistent language and criteria for the Informed Consent Form (ICF), protocol eligibility, protocol dose modification, protocol safety, Case Report Forms (CRFs), CRF instructions, etc.
- Assist with Medical monitoring inquiries, and participates in safety meetings and tracks, analyzes and reports any potential safety events.
- Work with Medical Directors, Clinical Operations, Biostatistics, and other groups to conduct clinical review of study data.
- Review, analyze, and discuss clinical study reporting documents with Medical Directors.
- Slide deck preparation for communicating clinical development plans, clinical trial timelines, clinical data.
- Support Medical Directors in preparing for internal/external meetings and presentations
- Drafting and/or reviews of abstracts, posters, and coordinates further reviews with internal partners and stakeholders.
IGM is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status. All qualified applicants will receive consideration for employment.