Senior manager, Clinical Scientist at Bristol-Myers Squibb

Hyderabad, Telangana, India

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Not SpecifiedCompensation

Senior (5 to 8 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-Pharmacology preferred
Basic knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations
Ability to understand assigned protocol(s) and their requirements
Basic knowledge skills to support program-specific data review and trend identification
Intermediate medical writing skills and medical terminology
Basic planning/project management skills (develop short range plans that are realistic and effective)
Detail-oriented with commitment to quality
Basic knowledge of disease area, compound, current clinical landscape
Basic knowledge of the establishment and operation of data monitoring committees, dose review teams, and independent response adjudication committees
Intermediate critical thinking and problem-solving skills
Adaptable / flexible (willing and able to adjust to multiple demands and shifting priorities; ability to meet day-to-day challenges with confidence and professionalism)
Intermediate skills in Microsoft Word/Excel/PowerPoint and data review tools (e.g., Pt Profiles, report generating tools)
Willingness to travel domestically and internationally as required

Responsibilities

Collaborate and liaise with external partners (e.g., KOLs)
Seek out and enact best practices with instruction
Provide regular and timely updates to manager/management as requested
Develop Protocol and ICF documents / amendments and present these to governance committee and development team meetings as required
Conduct literature review
Submit clinical documents to TMF
Develop site and CRA training materials and present these at SIVs and Investigator meetings
Review clinical narratives
Monitor clinical data for specific trends
Develop Data Review Plan in collaboration with Data Management
Ensure CRF design adequately supports data collection in alignment with the protocol in collaboration with Data Management/Programming
Submit clinical contributions to clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., IB, DSUR, PSUR, Orphan Annual Reports, HA, EC, IRB responses and contribute to regulatory submission)
Be responsible for design and execution of assigned clinical trial activities and work closely with clinical team members within the assigned project to execute activities associated with the conduct
May serve as Clinical Trial Lead for one or more trials
May lead or support trial level activities for one or more trials with the necessary supervision
May co-lead study team meetings in partnership with GDO protocol manager and collaborate with cross-functional study team members

Skills

Clinical Trials

Protocol Development

ICF Development

KOL Engagement

Cross-Functional Collaboration

Study Team Leadership

Drug Development

Trial Execution

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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