Disease Area Specialist, Clinical Trial & Pipeline

Bristol Myers Squibb

3-4 years

Not Disclosed

Mumbai, Navi Mumbai, India

Openings: 10 June 3, 2026

Job Description

Job Type: Full Time Hybrid Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Apache Spark, Artificial Intelligence (AI), Big Data, Data Governance, Data Literacy, Data Management, Data Quality, Data Science, Data Strategies, Data Visualization, Machine Learning (ML), Master Da, Auditing, Audit Management, Audits Compliance, Communication, Continued Learning, Decision Making, Gmp Procedures, Inspection Readiness, Managing Ambiguity, Organizing, People Management and Leadershi, Bachelor’s Degree (BS) or Master’s Degree (MS) in: Life Sciences Pharmacy Biotechnology Biomedical Sciences Chemistry Regulatory Affairs Or related scientific disciplines, Budget Management, Clinical Trials, Negotiation Skills, Process Improvement, Project Planning, Vendor Management, Waterfall Model, Building Construction, Clinical Practices, Clinical Research, Clinical Trials, Drug Development, Hazard Identification, Health Sciences, Immunology, Intensive Care UnIT (Icu), Internal Control, Intern, Building Construction, Clinical Practices, Clinical Research, Clinical Trials, Drug Development, Hazard Identification, Health Sciences, Immunology, Intensive Care UnIT (Icu), Internal Control, Intern, Building Construction, Clinical Practices, Clinical Research, Clinical Trials, Drug Development, Hazard Identification, Health Sciences, Immunology, Intensive Care UnIT (Icu), Internal Control, Intern, Building Construction, Clinical Practices, Clinical Research, Clinical Trials, Drug Development, Hazard Identification, Health Sciences, Immunology, Intensive Care UnIT (Icu), Internal Control, Intern, Causality Assessment, Change Control, Continual Improvement Process, Data Analytics and Digital, GDP Knowledge, gmp knowledge, HSE Knowledge, Manufacturing Process, Manufacturing Production, Operational Excellence, Process, Clinical Monitoring, Clinical Research, Clinical Study Reports, Clinical Trial Management Systems, Clinical Trials, Collaboration, Data Integrity, Decision Making Skills, Lifesciences, Clinical Research, Clinical Trials, Curious Mindset, Databases, Drug Development, Job Description, Lifesciences, Medical Communication, Medical Information, Medical Writing, Military Intelligence, Pat, Clinical SAS Programming, Clinical Trials, Cross-Functional Teams, Drug Development, Lifesciences, Negotiation Skills, People Management, Problem Solving Skills, Regulatory Compliance, Risk Management, Strategy Execution, Clinical Trials, Detail-Oriented, Drug Development, Lifesciences, Negotiation Skills, Regulatory Compliance, Clinical Trials, Functional Teams, Literature Review, Management Skills, Medical Information, Medical Records, Medical Strategy, Pharmacovigilance, Regulatory Compliance, Risk Management, Safety Scien, Coaching Skills, Data Science, Environment, Experiments Design, Health And Safety (Ehs), Laboratory Equipment, Manufacturing Process, Materials Science, Process Simulation, Sop (Standard Operating Pro, Collaboration, Communication Skills, gmp, GMP Guidelines, Operational Excellence, Problem Solving Skills, Quality Agreements, Quality Compliance, Quality Management, Quality Standards, Regulatory Requ, Communication Skills, Continual Improvement Process, Master Data, Material Requirements Planning (Mrp), Materials Management, People Management, Production Planning, Supplier Relationship Management (Srm), Supply-Chain Man, CPC Certified, Data Analysis, Document Management, Life Science, Regulatory Compliance, Waterfall Model, Environment, Experiments Design, Health And Safety (Ehs), Laboratory Equipment, Manufacturing Process, Materials Science, Process Simulation, Sop (Standard Operating Procedure), Technical Writing, Wat, GCP guidelines, gmp knowledge, HSE Knowledge , Logistics and Transportation Management, Master Data, Operational Excellence, Sap Erp, supply chain management, Supply Planning, Warehouse Management, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, mRS and EQ-5D-5L., Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Disease Area Specialist, Clinical Trial & Pipeline

Company: Bristol Myers Squibb (BMS)
Location: Mumbai, MH, India
Job ID: R1602160
Employment Type: Full-time

Role Overview

The Disease Area Specialist (DAS) is a medical and clinical strategy-focused role within Bristol Myers Squibb’s pipeline and clinical development function. The role acts as a scientific and strategic partner, driving clinical development, supporting clinical trials, and shaping disease area strategy aligned with global medical objectives.

This position combines medical affairs, clinical development leadership, and stakeholder engagement, with both office-based and field responsibilities (~20–30% field work).

Key Responsibilities

1. Medical & Clinical Strategy

Align country medical activities with global pipeline and therapeutic area (TA) strategies.
Implement therapy area initiatives aligned with worldwide medical strategy.
Contribute to Early Product Planning (EPP) and global/regional pipeline working groups.
Translate global pipeline insights into India-specific medical strategy.

2. Clinical Development & Trial Leadership (Phase 1–3)

Provide strategic and tactical input into clinical development plans.
Support feasibility assessments and clinical trial design.
Lead country-level clinical trial strategy for pipeline assets.
Monitor competitive landscape and emerging clinical data to inform strategy.

3. Clinical Trial Execution Support

Support study start-up, recruitment planning, and execution.
Identify and mitigate risks that may impact trial timelines.
Provide protocol training to CRAs, investigators, and site teams.
Represent the company at investigator meetings and scientific forums.

4. Stakeholder Engagement & KOL Management

Engage with Key Opinion Leaders (KOLs) and scientific experts.
Build scientific advocacy and gather insights for clinical development.
Serve as primary medical contact for investigators and clinical sites.

5. Regulatory & Ethics Interaction Support

Support interactions with:
- IEC/IRB committees
- Health authorities and regulatory bodies
- Ministry of Health (as required)
Assist with CTA filings, NDA discussions, and labeling activities.
Support regulatory inspections and GCP audits.

6. Pharmacovigilance & Patient Safety

Review adverse events (AE/SAE) for development compounds.
Support patient safety teams with medical assessments.
Provide pharmacovigilance input and risk-benefit evaluations.

7. Cross-Functional Collaboration

Work closely with:
- Market Access
- HEOR (Health Economics and Outcomes Research)
- Regulatory Affairs
- Commercial teams
Provide medical input for regulatory filings and access strategies.

8. Evidence Generation & RWE

Utilize real-world evidence (RWE), registries, and epidemiological data.
Support innovative clinical trial designs.
Strengthen evidence generation for pipeline and access strategies.

9. Training & Scientific Leadership

Train MSLs, field medical teams, sales, and marketing teams.
Provide scientific mentoring to new team members.
Ensure continuous medical knowledge development across teams.

10. Compliance & Culture

Ensure adherence to:
- ICH-GCP guidelines
- Local regulatory requirements
- Company policies and ethical standards
Promote a culture of innovation, accountability, and scientific excellence.

Required Qualifications

Education

Medical degree preferred:
- MBBS / MD (strongly preferred)

Experience

3–4 years of experience in:
- Medical Affairs
- Clinical Development
- Pharmaceutical industry
Strong understanding of:
- Clinical trial processes
- ICH-GCP guidelines
- Drug development lifecycle

Skills & Competencies

Strategic & Analytical Skills

Strategic thinking and planning
Ability to interpret clinical data and scientific evidence
Strong problem-solving in complex clinical scenarios

Communication & Influence

Excellent verbal and written communication skills
Ability to influence cross-functional and global stakeholders
Strong stakeholder engagement and relationship building

Leadership & Execution

Ability to lead clinical programs from medical perspective
Strong decision-making and judgment
Ability to manage competing priorities in fast-paced environment

Behavioral Competencies

Intellectual curiosity and learning agility
Collaboration in matrix organizations
Change leadership and adaptability
High accountability and ownership

Work Environment

Hybrid role: Office-based with ~20–30% field engagement
Interaction with global and regional teams
Exposure to clinical, regulatory, and commercial environments

Key Focus Areas

Clinical trial leadership (Phase I–III)
Disease area strategy development
Pipeline asset development support
Medical and scientific leadership
Cross-functional integration across R&D and commercial teams

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Disease Area Specialist, Clinical Trial & Pipeline

Job Description

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