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Clinical Scientist, Early Clinical

hace 1 mes

Sevilla, España Bristol-Myers Squibb A tiempo completo

**Working with Us**
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

The Early Clinical Development (ECD-HOCT) team at BMS is responsible for hematology, oncology and cell therapy pipeline assets and sits at the interface between discovery and translational science and clinical drug development. Composed of physician-scientists and clinical-scientists, this group oversees the early development of both internal and partnered assets covering all platforms of therapies, including small molecules, traditional and complex biologics and next gen cell therapies. Therapeutic areas span the full range of hematologic and solid tumor indications. The ECD-HOCT team interacts hand-in-glove with discovery and translational scientists, project leadership, late development and commercial colleagues to optimize biomarker, patient enrichment, dosing and combination strategies to enable faster and more effective drug development informed by core scientific principals and data.

**Functional Area Description**

The Early Development Clinical Scientist function provides scientific expertise necessary to design and deliver clinical studies and programs.

**Position Summary/Objective**:

- Responsible for design and execution of assigned clinical trial activities and works closely with clinical team members to execute activities associated with trial conduct.
- May lead or support trial level activities for one or more trials with the necessary supervision.

**Position Responsibilities**:

- Collaborate and liaise with external partners (e.g., KOLs).
- Seek out and enact best practices with instruction.
- Provide regular and timely updates to manager/management as requested.
- Collaborate cross-functionally to develop Protocol and ICF documents / amendments and present these to governance committee and early clinical development team meetings as required.
- Conduct literature review.
- Develop site and CRA training materials and present these at SIVs and Investigator meetings.
- Review clinical narratives.
- Collaborate cross-functionally to monitor clinical data for specific trends.
- Contribute to the development of Data Review Plan in collaboration with Data Management.
- Ensure CRF design adequately supports data collection in alignment with the protocol in collaboration with Data Management/Programming.
- Author/review clinical contributions to clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., Pre-IND, IND, IB, DSUR, PSUR, Orphan Annual Reports, HA, EC, IRB responses and contribute to regulatory submission.)
- Submit clinical documents to TMF.

**Degree Requirements**:

- Degree in Life Sciences (MD, PhD, Pharm D, MS, RN or similar scientific field preferred).

**Experience Requirements**:

- Expectation of 2+ years of experience in clinical science, clinical research, or equivalent, hematology and oncology prior experience preferred.
- Proficient knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations.
- Ability to understand assigned protocol(s) and their requirements.
- Knowledge and skills to support program-specific data review and trend identification.
- Intermediate medical writing skills and medical terminology.
- Basic knowledge of the establishment and operation of data monitoring committees, dose review teams, and independent response adjudication committees.

**Key Competency Requirements**:

- Basic planning/project management skills (develop short range plans that are realistic and effective)
- Basic knowledge of disease area, compound, current clinical landscape.
- Detail-oriented with commitment to quality
- Intermediate critical thinking and problem-solving skills.
- Adaptable / flexible (willing and able to adjust to multiple demands and shifting priorities; ability to meet day-to-day challenges with confidence and professionalism)
- Intermediate skills in Microsoft Word/Excel/PowerPoint and data review tools (e.g., patient profiles, report generating tools)
- Domestic and international travel may be required (approximately 10-20%)

The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed.

Final, individual compensation will be decided based on demonstrated experience.
- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holiday