Senior Manager, Japan Clinical Trial Physician at Bristol-Myers Squibb

Kariya-shi, Aichi, Japan

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

PharmaceuticalsIndustries

Requirements

In-depth knowledge of etiology, natural history, diagnosis, and treatment of the disorder in the relevant disease area
Strong expertise in the disease area, maintained through attending scientific conferences and ongoing review of literature
Knowledge of asset/drug, disease area, and relevant science to meet regulatory and disease strategy targets
Keeps abreast of development and regulatory issues related to competitive or relevant compounds and portfolio fit in the competitive landscape
Fulfills GCP and compliance obligations for clinical conduct and maintains all required training
Maintains a strong medical/scientific reputation within the disease area

Responsibilities

Conducts medical data review of trial data, including eligibility review
Holds responsibility for site interactions in partnership with the Japan Clinical Lead or Clinical Scientist for medical questions and education (including safety management guidelines)
Holds responsibility for assessment of key safety-related serious adverse events of R&D clinical trials in partnership with Worldwide Patient Safety and oversees safety narratives
Collaborates with Japan Clinical Lead or Clinical Scientist and inputs into protocols, providing medical strategic oversight in protocol development (input on inclusion/exclusion and other safety-related clinical considerations)
Assists global CTP as needed from local perspectives for global studies (e.g., provide local medical related input, resolve local medical related issues)
Takes primary CTP role for local initiated trials or programs
In collaboration with the Japan Program Development Team such as Clinical Lead, designs and develops project/clinical plans and protocols with a strong strategic focus
Provides oversight and medical accountability for a group of studies
Leads the analysis of benefit/risk for clinical development protocols and projects in a matrix team environment working with Japan TA
Partners with Japan Program Development Team such as Clinical Lead to support executional delivery of studies (e.g., enrollment review, as well as adjudication for protocol violations, significant, non-significant deviations etc.)
Identifies and builds relationships with principal investigators
Identifies and cultivates thought leaders in order to gain their inputs on emerging science in drug and biomarker research, disease knowledge, and design of clinical development studies and programs

Skills

Clinical Trials

Medical Monitoring

Protocol Development

Safety Management

Adverse Event Assessment

Site Interactions

Patient Safety

Eligibility Review

Safety Narratives

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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