Associate Director, Senior Clinical Scientist – Hyderabad, India
Employer
Bristol Myers Squibb (BMS)
Location
Hyderabad, Telangana, India – On-site / Hybrid options available
Category
Clinical Research / Medical Affairs
Job Overview
Bristol Myers Squibb (BMS) is seeking an experienced Associate Director, Senior Clinical Scientist to lead and execute clinical trial activities across multiple therapeutic programs. This role provides scientific and clinical leadership, serving as the Clinical Trial Lead and guiding a team of Clinical Scientists in delivering high-quality clinical data to support drug development and regulatory submissions.
The ideal candidate will have expertise in GCP-compliant clinical trial execution, protocol development, and data oversight, contributing to innovative solutions for patients with serious diseases.
Key Responsibilities
Clinical Trial Leadership & Execution
Lead planning, implementation, and management of assigned clinical trials with minimal supervision.
Serve as Clinical Trial Lead for one or more studies, overseeing protocol adherence, site management, and trial conduct.
Co-lead study team meetings with the GDO Protocol Manager and collaborate with cross-functional teams.
Support clinical development planning by analyzing trial data to inform future studies.
Protocol & Clinical Data Management
Maintain thorough understanding of trial protocols and educate supporting teams.
Manage all phases of study activities, including start-up, conduct, and close-out.
Participate in protocol and Informed Consent Form (ICF) development, ensuring clinical quality and regulatory compliance.
Oversee site-facing activities such as site training and serving as primary contact for clinical questions.
Support data generation, CRF design, clinical data review, query resolution, and ensure high-quality data by the team.
Identify trends in clinical data and escalate key observations to the Medical Monitor.
Reporting & Regulatory Support
Draft, review, and validate Clinical Study Reports (CSRs) and clinical portions of regulatory documents (IB, DSUR, responses).
Liaise with external partners to provide scientific advice and support regulatory submissions.
Support Data Monitoring Committees (DMCs) and other study committees as required.
Team & Cross-Functional Collaboration
Provide scientific mentorship to supporting Clinical Scientists.
Develop and deliver training materials for sites and CRAs.
Foster collaboration across multiple functions including Medical Writing, Clinical Operations, Biostatistics, and Regulatory Affairs.
Required Qualifications
Education & Experience
Advanced degree in Life Sciences preferred (MD, PharmD, PhD, MS, RN). MD in Pharmacology is highly desirable.
Minimum 10+ years of experience in clinical research, clinical science, or equivalent.
In-depth knowledge of GCP/ICH guidelines, clinical trial design, medical monitoring, and drug development processes.
Skills & Competencies
Expertise in clinical data review, trend analysis, and safety monitoring.
Knowledge of Data Monitoring Committees, dose review, and independent adjudication committees.
Strong verbal and written communication, including scientific writing and presentations.
Demonstrated ability to lead teams, manage multiple projects, and make data-driven decisions.
Proficiency in Medical Terminology, Microsoft Office, Electronic Data Capture systems (e.g., RAVE, J-Review).
Ability to adapt to shifting priorities and work collaboratively in a matrix environment.
Travel Requirements
Domestic and international travel may be required.
Why Join BMS
Be part of a mission-driven organization transforming patient lives through science™.
Engage in uniquely challenging and meaningful work across global clinical trials.
Access competitive benefits, professional development, and a collaborative, inclusive workplace.
Flexible work arrangements and opportunities to innovate in clinical research and drug development.
Application Process
Qualified candidates can apply via BMS Careers. Bristol Myers Squibb is an Equal Opportunity Employer, committed to diversity, equity, inclusion, and providing reasonable workplace accommodations.
Gujarat :
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