Associate Director, Senior Clinical Scientist at Bristol-Myers Squibb

Hyderabad, Telangana, India

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, BiotechnologyIndustries

Requirements

Degree in Life Sciences (MD, PhD, Pharm D, MS, RN or other scientific field preferred). MD in Pharmacology preferred
10+ years of experience in clinical science, clinical research, or equivalent
Proficient knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations

Responsibilities

Maintain a thorough understanding of assigned protocols and protocol requirements; educate supporting team members
Plan and lead the implementation of 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 escalate 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
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 collaborate 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)

Skills

Clinical Trials

Study Design

Clinical Development

Protocol Management

Cross-Functional Collaboration

Scientific Leadership

Data Analysis

Trial Execution

Team Leadership

Clinical Science

Bristol-Myers Squibb

Develops and delivers biopharmaceutical medicines

About Bristol-Myers Squibb

Bristol Myers Squibb (BMS) develops and delivers medicines aimed at treating serious diseases, focusing on areas like cancer, autoimmune diseases, and heart conditions. The company conducts extensive research and development to create new drugs, which are sold after receiving regulatory approval. BMS also produces generic drugs, offering affordable alternatives that meet the same quality standards as their branded counterparts. What sets BMS apart from competitors is its dual focus on both innovative and generic medicines, enhancing access to healthcare. The company's goal is to improve patient outcomes while maintaining a commitment to sustainability and corporate responsibility.

New York City, New YorkHeadquarters

1887Year Founded

$33,706.1MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Benefits

Flexible Work Hours

Hybrid Work Options

Professional Development Budget

Risks

Increased competition in oncology from emerging biotech firms like ArsenalBio.

BMS's lawsuit over the 340B Drug Pricing Program may lead to regulatory challenges.

Rapid AI and digital tech evolution may pose integration challenges for BMS.

Differentiation

BMS focuses on innovative cancer treatments through collaborations like ArsenalBio for T cell therapies.

The company emphasizes digital health technologies, enhancing clinical trial management and patient engagement.

BMS offers both innovative and generic medicines, increasing affordable healthcare solutions.

Upsides

BMS's partnership with Medidata enhances clinical research processes and patient outcomes.

The collaboration with AI Proteins advances novel miniprotein-based therapeutics, expanding therapeutic modalities.

BMS's global license agreement with BioArctic expands its portfolio in neurodegenerative diseases.

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