Associate Director, Global Clinical Science - Neuroscience

Bristol-Myers Squibb Co; Uxbridge; Presencial; GBP 90.000 - 130.000; Jornada completa

Descripción de la vacante

Bristol Myers Squibb in the United Kingdom is seeking a Clinical Trial Lead responsible for implementation, planning, and execution of assigned trial activities across multiple studies. You will provide scientific and clinical leadership and collaborate with cross-functional study teams.

The role requires a life sciences degree and 5+ years in clinical science or clinical research, with strong GCP/ICH knowledge, data interpretation, protocol development, and stakeholder management.

Formación

• Degree in Life Sciences or equivalent with advanced training in clinical research.
• 5+ years of experience in clinical science, clinical research, or equivalent.
• Proficient knowledge of GCP/ICH and drug development processes.

Responsabilidades

• Maintain a thorough understanding of assigned protocols and educate supporting team members.
• Plan and lead the implementation of all study startup/conduct/close-out activities.
• Evaluate innovative trial designs in collaboration with Medical Monitor/Clinical Development Lead.
• Protocol and ICF development with cross-functional input and high clinical quality.
• Site-facing activities including training and primary contact for clinical questions.
• Data generation and validation, including CRF design and data review.
• Identify data trends and escalate questions to Medical Monitor.
• Develop clinical narratives and review clinical narratives.
• Provide information for budget development, CRO scope, etc.
• Review development of site and CRA training materials and study committee support.
• Draft/validate CSR and regulatory documents.
• Collaborate with external partners for scientific advice.
• Domestic and international travel may be required.

Conocimientos

Clinical trial leadership

GCP/ICH knowledge

Cross-functional collaboration

Data review and interpretation

Project management

Educación

Degree in Life Sciences (MD/PhD/PharmD/MS preferred)

Herramientas

RAVE

J-Review

MS Office

Descripción del empleo

Summary

Responsible for implementation, planning, and execution of assigned clinical trial activities. Serves as Clinical Trial Lead for one or more trials. Successfully leads, plans, and executes trial level activities for multiple trials with minimal to moderate level of supervision. Provides scientific and clinical leadership to team of supporting Clinical Scientists (matrix leadership). Co-Leads study team meetings in partnership with GDO protocol manager; and collaborates with cross functional study team members. May support clinical development planning (collaboration with Clinical Development Lead/Clinical Trial Physician for provision and analysis of data to support future planning).

Position Responsibilities

• Maintain a thorough understanding of assigned protocols and protocol requirements; educate supporting team members.


• Plan and lead the implementation all study startup/conduct/close-out activities as applicable.


• Evaluate innovative trial designs (collaboration with Medical Monitor/Clinical Development Lead).


• Protocol and ICF development process with minimal guidance; including writing, reviewing, adjudication/resolution of cross functional comments and ensuring high clinical quality (collaboration with Medical Writing).


• Site-facing activities such as training and serving as primary contact for clinical questions.


• Activities related to data generation and validation, including CRF design, clinical data review/query resolution; ensure consistent, quality data review by supporting CS team.


• Clinical data trend identification; provide trends and elevate questions to Medical Monitor.


• Develop clinical narrative plan; review clinical narratives.


• Provision of information required by Protocol Manager for development of trial budget, CRO scope of work, etc.


• Review development of site and CRA training materials and presentation at SIV and Investigator meetings and support on Study committee (e.g., DMC) activities.


• Drafting/review and validation of clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., IB, DSUR, regulatory responses).


• Collaborate and serve as primary liaison between external partners for scientific advice.


• Domestic and International travel may be required.

Requirements

• Degree in Life Sciences (MD, PhD, Pharm D, MS, RN or other 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.


• Must be able to effectively communicate and collaborate across functions and job levels.


• Ability to assimilate technical information quickly.


• Routinely takes initiative.


• Detail-oriented.


• Strong sense of teamwork; ability to lead team activities.


• Proficient in Medical Terminology and medical writing skills.


• Proficient knowledge of the disease area(s), KOLs, indication(s), compound(s) under study (including MOA, PK/PD, biomarker & safety profile).


• Proficient critical thinking, problem solving, decision making skills.


• Understanding of functional and cross-functional relationships.


• Commitment to Quality.


• Adaptable / Flexible - willing and able to adjust to multiple demands and shifting priorities as well as an ability to meet day-to-day challenges with confidence and professionalism.


• Proficient planning/project management skills (ability to develop short to mid-range plans that are realistic and effective in meeting goals).


• Proficient in Microsoft Word, Excel, PowerPoint, Electronic Data Capture (e.g., RAVE), J-Review or similar data reporting tools.

How We Work

Where you work matters – because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working.

Supporting People with Disabilities

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to [e-mail]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement. Bristol Myers Squibb is Disability Confident – Employer A UK Government scheme Candidate Rights BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. For roles based in LosAngelesCounty only: If you live in or expect to work from LosAngelesCounty if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

About Our Mission

We’re creating innovative medicines for patients fighting serious diseases. We’re also nurturing our own diverse team with inspiring work and challenging career options. No matter the role, each one of us makes a contribution. And that makes all the difference.