- Provide strategic input for innovative clinical development plans, incorporating the current therapeutic area landscape
- Lead the design and implementation of early stage clinical projects, with responsibility for medical aspects of phase 1-2 clinical trials
- Serve as lead author of clinical documents: protocols, investigator's brochures, case report form design and data analysis plans
- Participate/lead the preparation of clinical sections of relevant regulatory filings to Health Authorities
- Partner closely with the Clinical Operations head in the conduct and execution of Nurix's clinical trials
- Serve as Medical Monitor for clinical trials, reviewing safety and efficacy data for routine medical data review, trend review, and safety signals from ongoing trials
- Support exploratory biomarker efforts to aid clinical and project data-driven decisions
- Lead medical aspects of investigator and clinical advisory boards
- Develop and manage relationships with key opinion leaders for clinical programs
- Represent Nurix at external events, including scientific and medical conferences and business development activities
- MD with board certification or eligibility in Oncology or Hematology/Oncology
- 3-5 years of drug development experience in biotechnology or pharmaceutical industry, or a combination of academia and industry
- Proven experience with clinical trial design, execution, medical monitoring, and reporting of controlled clinical trials in oncology including working with external service providers
- Experience with design, execution, and analysis of Phase 1-2 clinical oncology studies with small molecule targeted or immunological therapies
- Demonstrable knowledge of regulatory procedures and guidelines in the US and other geographic regions
- Understanding of basic science relevant to clinical oncology
- Ability to work collaboratively in a fast-paced matrix environment
- Excellent written and oral communication skills
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Medical Director - San Francisco, United States - BioSpace
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Description
Job DetailsMedical Director - Sr. Medical Director, Clinical Development (MD)
We are seeking an experienced clinician with strong leadership skills who is driven by science and the desire to develop novel therapies for cancer patients. The successful candidate will have expertise in the design and conduct of early phase oncology clinical trials and a strong interest in translational medicine.
Reporting to the Head of Clinical Development, the individual will be responsible for the design, implementation, monitoring, data analysis and reporting of clinical studies for Nurix's oncology portfolio. The individual will also serve as a medical expert resource for drug discovery teams and business development activities. The role provides an opportunity for leadership growth in a dynamic small company environment.
Specific responsibilities include: