Nurix has a place for an extraordinary, highly motivated, and accomplished Director/Senior Director, Clinical Scientist.
As an integral member of the Clinical Development Team, this person will help to develop innovative solutions for the clinical development of Nurix’s pioneering protein modulation programs in hematology, oncology, and cell therapy. Working in close collaboration with the study teams, the incumbent will provide scientific guidance and support.
This role will is responsible for various aspects of clinical study design and execution including: protocol writing, building study infrastructure, staff training, data cleaning/analysis, investigator interaction and support of regulatory filings. In addition, this role will be responsible for providing supporting rationale for clinical development working closely with the Head of Development.
- Participate in and contribute to cross-functional clinical development teams with strong ability to work closely with all team members, address study or other program-specific questions.
- Develop the Global Development plan with senior clinical development staff
- Implement Global Development Plan with strategic clinical science support
- Assist in reviewing and authoring clinical protocol. Read and interpret scientific and medical literature for the use in clinical documents and to assist clinical team decision making.
- Prepare clinical portions of all relevant regulatory filings and meeting packages (INDs, Annual Reports, meeting requests, NDAs, etc.) for US and ex-US Health Authorities.
- Integrate scientific knowledge and operational expertise to ensure translation of clinical research plans into efficiently delivered, high quality studies.
- Acquire and utilize knowledge of clinical trial design and relevant disease indications to assist in study concept and protocol development. Contribute to discussions concerning scientific and procedural aspects of study design. Coordinate with departments to produce the final protocol and informed consent documents.
- Compose medical data review plans, Data Safety Monitoring Board (DSMB), Safety Review Committee (SRC) charters, and specific sections of study manuals and investigator meeting materials.
- Contribute significantly to the development of CRFs, data edit checks, patient profile design, ongoing data cleaning (query generation, coding review, SAE reconciliation) and data trend analysis.
- Lead internal clinical data review meetings in conjunction with the medical monitor; lead the data preparation effort for dose escalation meeting, as applicable to study stage.
- Coordinate and manage external medical advisory committees for the study team such as DSMBs and Scientific Steering Committees, in conjunction with the medical monitor.
- Research and summarize published literature for continual learning and to prepare training materials for other clinical team members.
- Contribute to statistical analysis plans, table, listing, figure design and the preparation of manuscripts and other presentations of study data, as appropriate.
- Address investigator questions regarding protocol and related scientific issues and attend site initiation visits (SIVs), in coordination with the medical monitor.
- Assist in determining the activities to support a project's priorities within functional area
- Trains other clinical scientists as needed.
Advanced degree (MD, PhD, or PharmD) and 8+ year's relevant drug development experience
- Experience directly in the clinical science role, in a hematology/oncology indication for first-in-human and proof of concept studies in small molecules and/or cell therapy. Registrational or Phase 3 study experience is preferred.
- In depth understanding of clinical operations and translational medicine.
- Excellent interpersonal skills.
- Able to translate technical concepts into accessible language and direction for the broader study team.
- Excellent attention to detail, partnership and initiative, with flexibility to adapt to the needs of the organization; maintain meticulous attention to project deadlines.
- Experienced in Microsoft Office (Excel, Word, PowerPoint, OneNote), and ideally also with job related programs such as Spotfire and Medidata Rave or similar.
- Strong understanding of ICH GCP, as well as general knowledge of industry practices and standards
- Commitment to patient safety and clinical compliance.
Fit with Nurix Culture and Values
- Strong team orientation; highly collaborative
- Solutions and results-oriented focus
- Hands-on approach; resourceful and open to diverse points of view