Senior Director of Clinical Science
4 days ago
As a key member of the Clinical Development Team at Nurix Therapeutics, Inc., this role will play a critical part in advancing molecules through our clinical pipeline. The Senior/Executive Director, Clinical Science will report to the VP, Head of Clinical Science and be responsible for developing and contributing to the strategy to advance molecules through the Nurix clinical pipeline.
Key Responsibilities:- Participate in and lead cross-functional clinical development teams, working closely with all team members to address study or program-specific questions.
- Develop the Global Development Plan with senior clinical development staff and implement it with strategic clinical science support.
- Lead the review and authoring of clinical protocols, reading and interpreting scientific and medical literature for 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 the 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, contributing to discussions concerning scientific and procedural aspects of study design.
- 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 and lead the data preparation effort for dose escalation meetings, 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 areas.
- 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 a scientific/subject matter expert.
- Up to 25% travel (US and International).
Advanced degree in clinical or biological sciences (MD, PhD, or PharmD preferred) and 12+ year's (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 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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