Title: Clinical Scientist
Location: Menlo Park, CA
Forty Seven Inc. is committed to helping patients defeat their cancer. We are advancing immune-oncology through the engagement of new and complementary phagocytic pathways that enhance anti-tumor efficacy and selectivity. Our lead compound is a first-in-class antibody targeting CD47, a novel macrophage immune checkpoint which is in multiple clinical trials across solid tumor and hematologic malignancies.
Forty Seven, Inc. is a clinical-stage biotech company that is pioneering breakthrough solutions to advance the next generation of immune-oncology treatments. We are seeking a Clinical Scientist that will be responsible for providing clinical leadership in the definition of clinical development strategies, as well as the design, execution, and analysis of clinical studies conducted with Forty Seven’s academic, community and industry partners. This individual should be passionate about oncology drug development and working in an innovative therapeutic field. This position reports to the Vice President, Clinical Development.
These may include, but are not limited to, the following; other duties may be assigned
- Responsible for the review of data listings, summary tables, and study results for multiple clinical trials/programs in oncology
- Review and present data for scientific presentations on clinical trial results for internal and external purposes, manuscripts, and regulatory interactions in collaboration with the clinical development team
- Assists in the preparation/review of regulatory documents, clinical protocols, IND annual reports, IND safety reports, Investigator Brochures and BLAs.
- May serve as the primary or supporting medical monitor on clinical trials with appropriate medical backup
- Participate in formulating the clinical development strategy including designing and implementing clinical trials and registrational plans in collaboration with the clinical development team
- Plays a key role in management of site/investigator relationships including site initiation visits, investigator calls, and investigator meetings
- Assists in generating company presentations regarding clinical development activities for internal and external stakeholders (i.e. core development teams, executive team, key opinion leaders)
- Work with multiple functional teams to accomplish goals (i.e. clinical development, operations, pharmacology, biometrics, research and development, regulatory, CMC, and finance)
Education & Experience:
- Advanced professional degree in health sciences (PhD in biosciences/clinical research/pharmacology, PharmD, or other equivalent)
- 3-5+ years of relevant scientific or drug development experience in industry to include trials experience
- Background or work experience in oncology required
- Ability to critically analyze and interpret scientific and clinical data and literature
- Translational or clinical trials experience in immuno-oncology is a plus
- Working knowledge of biostatistics, regulatory, clinical pharmacology and pharmacokinetics
- Ability to manage multiple tasks and prioritization skills in a fast-paced environment, work in a collaborative matrixed team environment
- Excellent interpersonal and communication skills (written and verbal)
- Proficient in Microsoft office (excel, powerpoint)
- Passionate about oncology drug development and working in an innovative therapeutic field
- Position may require occasional travel (~15-25%), domestic and international.