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

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
Works on multiple trials across early development clinical lifecycle
Maintains a thorough understanding of assigned protocols and protocol requirements and educates team members
Serves as an independent Medical Monitor for clinical trials from Phase 1 through Proof-of-Concept
Manages site interactions for medical questions and education (including safety management guidelines)

Responsibilities

Participates in designing and developing clinical studies and research plans in support of asset strategy with the Early Clinical Development Leadership team (e.g., first-in-human Phase I, proof of concept Phase I/II, entry registrational studies, biomarker qualification studies, 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
Leads the analysis of benefit/risk for clinical development protocols in a matrix team environment
Manages 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
Presents 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
Articulates clinical development strategy as principal functional author for Regulatory submission, study reports, and publications
Analyzes, interprets, and acts on clinical trial data to support development
Serves as primary contact for site-facing activities such as training and support for clinical questions to support executional delivery of studies (e.g., site activation, enrollment status, adjudication for protocol violations, significant, non-significant deviations etc.)
Conducts and oversees activities related to data generation and validation, including CRF design, clinical data review/query resolution; ensures consistent, quality data review
Identifies clinical data trends; provides trends and escalates questions to study physician
Assesses key safety-related serious adverse events in partnership with Worldwide Patient Safety and oversees contributions to safety narratives
Develops clinical narrative plan and reviews clinical narratives
Authors/reviews clinical study reports (CSRs)

Skills

Clinical Trials

Phase I

Early Clinical Development

Biomarker Qualification

Clinical Pharmacology

Trial Planning

Medical Oversight

Asset Strategy

Dose Selection

Patient Selection

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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