POSITION SUMMARY:
The Senior Clinical Scientist, Oncology will leverage their scientific and medical expertise in oncology to lead and execute clinical development activities for one or more assigned studies in molecular residual disease monitoring. Acting as a key leader on study teams and departmental initiatives, they will drive the development of clinical strategy, incorporating insights from the competitive landscape and aligning with the broader company vision to advance innovative solutions in oncology.
PRIMARY RESPONSIBILITIES:
- Develop study concepts, including overall study design, schedule of assessments, objectives / endpoints, and eligibility criteria. Integrate feedback from internal and external stakeholders including senior leadership, key investigators, internal stakeholders, and regulatory agencies
- Contribute to authoring of the study protocol and provide critical feedback and review of supporting documents; help to respond to health authority feedback
- Provide protocol trainings to internal and CRO teams
- Work with the Clinical Operations team to contribute to the design of study-specific case report form (CRF), ensure CRFs are aligned with study requirements during user acceptance testing, and author study-specific sections of the CRF completion guidelines
- Ensure study manuals, etc. are aligned with the study protocol
- Seek input from key investigators on study design and methodology to ensure alignment with research objectives, and actively participate in pre-site selection discussions, site initiation visits, and investigator meetings to support successful study execution
- Serve as clinical science representative on internal and external meetings
- Contribute to and oversee real-time clinical data reviews (including oversight of CROs when applicable)
- Support advisory boards, steering committee meetings, consultant meetings and investigator meetings, including preparation and delivery of presentations
- Engage Natera medical directors, medical science liaisons for clinical projects, abstract writing and content creation
- Deliver presentations/posters at scientific meetings and company promotional events as needed; represent company at trade shows and medical conferences (<10% travel)
- This role works with PHI on a regular basis both in paper and electronic form and has access to various technologies to access PHI (paper and electronic) in order to perform the job.
- Employee must complete training relating to HIPAA/PHI privacy, General Policies and Procedure Compliance training and security training as soon as possible but not later than the first 30 days of hire
- Must maintain a current status on Natera training requirements
- Performs other duties as assigned
QUALIFICATIONS:
- PhD/RN/MS
- At least 5-8 years experience as a Clinical Scientist preferred with preference given to o