In this role, you will have the opportunity to work independently and collaboratively in an exciting young company.
The Clinical Scientist will be an essential contributor in building and maintaining unified development plan, as well as, provide support to developmental activities. This role will assist in providing clinical guidance and assessment of future opportunities and address unmet requirements in the oncology clinical development space.
Job Duties and Responsibilities:
Responsibilities may include, but are not limited to:
- Design, oversee and/or execute, as needed and as appropriate, clinical deliverables and clinical/translational strategy for collaborative studies and programs
- Support the evaluation of new project opportunities presented by member researchers across the consortium and external partners
- May be responsible for oversight of study and overall timelines for key deliverables
- Development assessments of clinical programs to support therapeutic advancements using innovative approaches and new therapeutic initiatives
- Clinical support on implementation teams, providing subject matter expertise, clinical science support and functional representation
- Key clinical deliverables include document development: Study concepts/ synopses, clinical protocols, investigator’s drug brochures (IB), clinical study reports (CSR), ICF, and other regulatory documents
- Review, analyze, interpret, and present both clinical and translational data both internally and externally
- Write and/or review collaborative abstracts, posters, and content for scientific meetings, conferences and publications. Support publication strategy execution including collaboration with investigators, KOLs, medical affairs and other internal/external stakeholders. Present at investigator meetings and scientific conferences
- Ensure the appropriate reporting of safety events to the Clinical Development and applicable Regulatory Authorities throughout the life of the trial
- Act as the liaison between the Safety function and other internal functions as well as to external customers such as CROs, Clinical Events Committees and Data Safety Monitoring Boards associated with the trial
- Gather, extract, synthesize and present both clinical and aggregate safety data for signal detection review and evaluation.
- Perform and/or actively participate in signal detection meetings (including presentation of data) on a scheduled basis
- Responsible for understanding and implementing the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. May be asked to contribute to regulatory responses and discussions.
- This position will report to Clinical Development
- At least 3 years of experience at a pharmaceutical, CRO or biotechnology company or academic institution.
- Master/PhD degree in health science field, PharmD, MD (non-US MD acceptable), or other relevant advanced degree in a health science field. Experience in oncology or immunotherapy trials required, with drug development experience highly desirable
- Experience in molecular oncology or translational science is a plus
- Ability to think strategically and tactically with an interest in applied clinical research
- Ability to work effectively in multifunctional and multinational teams, as well as the ability to multitask and prioritize
- Demonstrated ability to evaluate, interpret and present complex scientific data
- Excellent verbal and written communication skills.