Associate Director, Senior Clinical Scientist

Bristol Myers Squibb

10 - 15 years

30 - 35 Lacs

hyderabad

Posted:1 day ago| Platform:

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Skills Required

gcp clinical trials clinical development clinical research oncology clinical pharmacology author microsoft medical writing clinical data

Work Mode

Work from Office

Job Type

Full Time

Job Description

Responsible for implementation, planning, and execution of assigned clinical trial activities in Early Clinical Development
Successfully leads, plans, and executes trial level activities for multiple trials with minimal to moderate level of supervision.
Serves as a primary source of medical accountability and oversight for multiple clinical trials.
Provides clinical, medical and scientific expertise to cross-functional BMS colleagues

Duties/Responsibilities

Participates in designing and developing clinical studies and research plans in support of asset strategy with the Early Clinical Development Leadership team; clinical studies include first-in-human Phase I, proof of concept Phase I/II, entry registrational studies, biomarker qualification studies, and/or clinical pharmacology studies
Liaises with Translational & Discovery Scientists and Development Teams to define dose and schedule, indications, and patient selection (e.g., biomarker qualification and implementation)
Provides oversight and medical accountability for multiple trials across early development clinical lifecycle Works on multiple trials across early development clinical lifecycle
Leads the analysis of benefit/risk for clinical development protocols in a matrix team environment
Maintains a thorough understanding of assigned protocols and protocol requirements and educate team members Manage protocol and ICF development process (e.g., documents and amendments) with minimal 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.
Plans and leads the implementation of clinical study startup/conduct/close-out activities as applicable.
Serves as an independent Medical Monitor for clinical trials from Phase 1 through Proof-of-Concept by
- Articulating clinical development strategy
- Analyzing, interpreting, and acting on clinical trial data to support development
- Serving as principal functional author for Regulatory submission, study reports, and publications
Serve as primary contact for site-facing activities such as training and support for clinical questions. Manages site interactions for medical questions and education (including safety management guidelines). To support executional delivery of studies (e.g., site activation, enrollment status, as well as adjudication for protocol violations, significant, non-significant deviations etc.)
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.
Assesses key safety-related serious adverse events in partnership with Worldwide Patient Safety and oversees contributions to safety narratives
Develop clinical narrative plan and review clinical narratives.
Author/review clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., pre-IND, IND, IB, DSUR, regulatory responses).
Fulfills GCP and compliance obligations for clinical conduct and maintains all required training
Maintains a strong medical/scientific reputation within the disease area; has in-depth knowledge of etiology, natural history, diagnosis, and treatment of the disorder
Contributes to key Health Authority interactions and advisory board meetings as Early Clinical Development Physician; serves as Primary Clinical Representative in Regulatory interactions for early development projects
Authors/drafts clinical content for CSRs, regulatory reports, briefing books and submission documents to support closure, clinical narratives, reporting and filling of the study
Author/review abstracts, presentations, and manuscripts for external publications
Track record or recognized for contributions to field (e.g., publications, patents, keynote participation in conferences etc.)

Qualifications

Specific Knowledge, Skills, Abilities:

MD or DM in Clinical Pharmacology or Oncology
10+ years of experience in clinical science, clinical research, or equivalent
Medical Monitoring experience in Early Clinical Development is desirable
Advanced knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations
Proficient in Microsoft Word, Excel, PowerPoint, Electronic Data Capture (e.g., RAVE), J-Review or similar data reporting tools
Experience in driving, managing and collaborating in a team/matrix work environment
Recognized internally and externally as a Therapeutic Area and Functional expert
Domestic and International travel may be required (10 - 25%).

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