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Senior Clinical Science Director
1 month ago
As a key member of the Clinical Development Team, this role will collaborate closely with study teams to provide scientific guidance and support. 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 cross-functional clinical development teams and contribute to the development of the Global Development Plan.
- Implement the Global Development Plan with strategic clinical science support.
- Lead the review and authoring of clinical protocols.
- Prepare clinical portions of regulatory filings and meeting packages.
- Integrate scientific knowledge and operational expertise to ensure the efficient delivery of 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 to the development of CRFs, data edit checks, patient profile design, ongoing data cleaning, and data trend analysis.
- Lead internal clinical data review meetings and manage external medical advisory committees.
- 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.
- Address investigator questions regarding protocol and related scientific issues.
- Assist in determining the activities to support a project's priorities within functional area.
- Train other clinical scientists as needed.
- 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.
- 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.
- 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.
- 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.
