Job Summary:
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 Associate Director/Director, Clinical Science will report to the VP, Head of Clinical Science or a more senior member of the Clinical Science team. They will be responsible for contributing to the strategy to advance molecules through the Nurix clinical pipeline. This role will work cross-functionally and participate in the execution 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.
Responsibilities:
- Participate, contribute to cross-functional clinical development teams with strong ability to work closely with all team members, address study or other program-specific questions.
- Implement Global Development Plan with strategic clinical science support.
- Authoring and/or reviewing 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 ex-US Health Authorities as needed.
- 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, and/or patient profile design.
- Conduct 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, if applicable
- Prepare slides as needed site calls and for dose escalation meeting, as applicable to study stage.
- Coordinate with Medical Affairs 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.
- Up to 25% travel (US and International)
Basic Qualifications
Advanced degree in clinical or biological sciences (MD, PhD, or PharmD preferred) and 4+ year's (Associate Dir) or 8+ years (Director) relevant drug development experience with minimum of 3 years' experience in oncology clinical trials.
Preferred Qualifications
- Experience in the clinical science role, in an oncology indication for first-in-human 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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