Senior Clinical Scientist, Early Clinical - Sevilla, España - Bristol Myers Squibb

Bristol Myers Squibb

Empresa verificada

Sevilla, España

hace 4 semanas

Publicado por:

Isabel García

beBee Recruiter

Descripción

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 position can be based in Seville (Spain), Boudry (Switzerland) or our Brisbane or Princeton offices in the US. We offer a 50-50% hybrid work arrangement.

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 implementation, planning, and execution of assigned clinical trial activities.
Successfully leads, plans, and executes trial level activities for multiple trials with mínimal to moderate level of supervision.
Provides scientific and clinical leadership to clinical scientists on study team (matrix leadership).
May support clinical development planning in collaboration with Early Clinical Development physician(s).

Position Responsibilities:

Maintain a thorough understanding of assigned protocols and protocol requirements and educate team members.
Plan and lead the implementation of clinical study startup/conduct/closeout activities as applicable.
Evaluate innovative trial designs in collaboration with the study physician.
Manage protocol and ICF development process (e.g., documents and amendments) with mínimal guidance; includes writing, reviewing, adjudication/resolution of cross functional comments and ensuring high clinical quality in collaboration with Medical Writing. Present to governance committee and early clinical development team meetings as required.
Serve as primary contact for sitefacing activities such as training and support for clinical questions.
Conduct and oversee activities related to data generation and validation, including CRF design, clinical data review/query resolution; ensure consistent, quality data review.
Identify clinical data trends; provide trends and escalate questions to study physician.
Develop clinical narrative plan and review clinical narratives.
Provide information required by Protocol Manager for development of trial budget, CRO scope of work, etc.
Review/develop site and CRA training materials and presentation at SIV and Investigator meetings and support on Study committee (e.g., safety review) activities.
Author/review clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., preIND, IND, IB, DSUR, regulatory responses).
Collaborate and serve as primary liaison between external partners for scientific advice.
Author/review abstracts, presentations, and manuscripts for external publications

Requirements:

Degree in Life Sciences (MD, PhD, Pharm D, MS, RN or similar scientific field preferred).
5+ years of experience in clinical science, clinical research, or equivalent.
Proficient knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations.
Proficient knowledge and skills to support program specific data review, trend identification, data interpretation
Knowledge of the establishment and operation of data monitoring committees, dose review teams, and independent response adjudication committees.
Excellent verbal, written, communication and interpersonal skills.
Able to effectively communicate and collaborate across functions and job levels.
Ability to assimilate technical information quickly.
Routinely takes initiative.
Detailoriented.
Strong sense of teamwork; ability to lead matrix team activities.
Proficient in Medical Terminology and medical writing skills.
Prof