- Job Type: Full-Time
- Function: Clinical Research
- Industry: Biotechnology
- Post Date: 09/20/2022
- Website: synthekine.com
- Company Address: 1505 Obrien Drive, Suite A/D, Menlo Park, California 94025, US
About SynthekineSynthekine is an engineered cytokine therapeutics company developing disease-optimized treatments. The company uses immunological insights to guide targeted protein engineering to generate transformative medicines for cancer and autoimmune disorders.
The clinical scientist (CS) is responsible for contributing to study design and execution of early phase (1/2) clinical studies in hematology/oncology. As a leader within the clinical organization, this individual will be overseeing clinical research organizations (CRO) in executing clinical studies, partnering with clinical operations and other matrix team members to design and refine clinical plans, authoring key clinical/regulatory documents, and ensuring exceptional delivery and interpretation of clinical data. The CS will strive to build and maintain collaborative relationships with investigators and clinical site staff, CROs, and Synthekine colleagues. The CS will foster a proactive and thoughtful approach to clinical study execution where obstacles are anticipated and effectively mitigated/resolved.
- Contributes to study design and amendments in collaboration with internal and external scientific stakeholders.
- Collaborates with MD, regulatory and other internal partners/stakeholders with authoring and submission of protocols, protocol amendments, regulatory filings, and other regulatory documentation.
- Collaborates with clinical operations, data management and CRO to develop and implement the overall data quality plan including active data review and trend analysis.
- Point-of-contact for clinical inquiries from CRO medical monitor and other stakeholders.
- Develops and provides input for clinical presentation slides and other materials for internal/external meetings and/or ongoing communications (e.g., investigator meetings, pre-study site selection visits, study coordinator or clinical research administrator training, study newsletters, communications to study sites, etc.)
- Partners with clinical operations and CRO in developing and maintaining study start up documents/resources (eg, ICF, Lab Manual, EDC, Safety monitoring Plan, etc.)
- Participates in safety meetings and tracks, analyzes, and reviews documentation for any potential safety events.
- Participates in the development and implementation of communications strategies to support existing and concluded studies. Includes KOL interactions, advisory boards, major medical meetings, congresses and other events, publications and other materials
- Writes and/or reviews abstracts, posters, content for scientific meetings, conferences, other events and presentations, and other publicly distributed materials and coordinates further reviews with internal partners and stakeholders.
- Coordinates submissions to scientific meetings and/or other appropriate venues or groups
- Writes clinical science sections of meeting packages and assists in the development and review of other clinical documentation required for regulatory submissions and other regulatory processes
- PhD, PharmD, MS (or equivalent), MD
- Minimum of 2 years’ experience in conducting Ph1/2 oncology/hematology clinical studies
- Excellent written and verbal communication skills
- Additional preferred qualifications:
○ Expertise in generating and interpreting immunology/immuno-oncology translational data in addition to clinical data
○ Expertise in conducting adoptive cell therapy studies
Synthekine requires all new hires to be fully vaccinated prior to the first date of employment (subject to any legally required exemptions).
Synthekine is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.