||Associate Director/Director, Clinical Research Scientist
||Florham Park, NJ
||VP, Clinical Development
- As a key member of the Clinical Development team, the Clinical Research Scientist (CRS) will work closely with the lead Clinical Research Physician to ensure that all phases of oncology therapeutic clinical development, including the design and implementation of clinical protocols and development plans, are achieved. This role provides exciting unique opportunity to make a strategic and scientific impact on current and future clinical programs in a growing development organization and to expand knowledge in the scientific and research aspects in oncology by working on several assets across multiple therapeutic areas through close interactions with the Research and Discovery teams within Hutchison MediPharma International and HMP Shanghai, China. The ideal candidate will help to build clinical expertise and be able to collaboratively design, plan, implement, analyze, and report clinical studies in a matrix organization.
Major Responsibilities and duties
- Works with VP Clinical Development and other project physician(s) and Clinical Research Scientists to direct and support the planning and implementation of clinical programs to meet corporate and clinical research goals.
- Assists or leads the protocol authoring or amendment process.
- Reviews, analyzes and interprets study results, including exploratory endpoints, assuring appropriate data review and accurate data reporting are completed.
- Contributes to database lock, statistical analysis plans, and preparation of Clinical Study Reports and other clinical documents, Investigator Brochures, INDs, NDA annual reports, integrated medical reports, and other regulatory submissions.
- Provides support for advisory boards, consultant meetings, and investigator meetings, including preparation and/or delivery of presentations.
- As part of the study team, supports the oversite of vendor scope of work (SOW) per contract, quality, and budget.
- Partners with Clinical Operations and Project Management to ensure study execution is progressing according to pre-determined performance metrics and quality indicators (timelines, milestones, expected deliverables).
- Partners with peer CRS’s to ensure consistency across individual studies and programs with respect to key execution processes.
- Participates in the creation and review and provides edits and feedback for standard operating procedures that relate to the clinical role.
Qualifications and Education Requirements
- BS/MS/MD/PhD in a related life science discipline required
- 5-7 years of industry experience in oncology clinical development (clinical science, clinical operations, medical writing, etc.)
- Comprehensive understanding of the drug development process from Phase 1 to Phase 3
- Solid understanding of all functional area responsibilities associated with clinical development process
- Ability to effectively collaborate with internal/external colleagues and stakeholders
- Comfortable working in a multi-national, matrix environment
- Leadership/influencing skills
- Manages conflicts/issues with internal and external partners and customers
- Able to anticipate, recognize and resolve problems/issues that may impact timelines and deliverables
- Excellent skills in oral and written communication
- Strong computer skills (e.g., Word, Excel, Project Management software, etc.)