Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery development and commercialization of targeted protein degradation medicines the next frontier in innovative drug design aimed at improving treatment options for patients with cancer and inflammatory diseases. Powered by a fully AIintegrated discovery engine capable of tackling any protein class and coupled with unparalleled ligase expertise Nurixs dedicated team has built a formidable advantage in translating the science of targeted protein degradation into clinical advancements. Nurix aims to establish degraderbased treatments at the forefront of patient care writing medicines next chapter with a new script to outmatch disease.
Senior Director Clinical Science
As an integral member of the Clinical Development Team this person will work closely in collaboration with the study teams providing scientific guidance and support.
The Senior/Executive Director Clinical Science will report to the VP Head of Clinical Science and will be responsible for developing and contributing to the strategy to advance molecules through the Nurix clinical pipeline. This role will work crossfunctionally and participate in the of clinical studies including protocols provide scientific expertise to support site and CRA training data cleaning/analysis investigator interaction and support of regulatory filings. In collaboration with the Medical Monitor and Safety team this role will be responsible for safety oversight of clinical trials.
Job Responsibilities:
- Participate contribute and/or lead crossfunctional clinical development teams with strong ability to work closely with all team members address study or other programspecific questions.
- Develop the Global Development plan with senior clinical development staff
- Implement Global Development Plan with strategic clinical science support
- Lead in reviewing and authoring clinical protocols. 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 exUS 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.
- Contribute and review 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 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 projects priorities within functional area
- Train other clinical scientists as needed.
- Medical monitoring duties may be considered depending on degree (e.g. PharmD MD or other clinical advanced degree) and previous experience.
- Support business development activities as needed serving as scientific/subject matter expert
- Up to 25 travel (US and International)
Basic Qualifications
Advanced degree in clinical or biological sciences (MD PhD or PharmD preferred) and 12 years (Senior Director) or 15 years (Executive Director) relevant drug development experience with minimum of 5 years experience in oncology clinical trials.
Preferred Qualifications
- Experience in the clinical science role in an oncology indication for firstinhuman and proof of concept studies in small molecules biologics and/or cell therapy. Registrational or Phase 3 study experience is desired.
- In depth understanding of clinical operations and translational medicine.
- Excellent interpersonal and communication skills.
- Able to translate technical concepts into accessible language and direction for the broader study team.
- Excellent attention to detail collaboration 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.
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