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Disease Area Specialist, Clinical Trial & Pipeline

Bristol Myers Squibb
3-4 years
Not Disclosed
Mumbai, India
1 June 4, 2026
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding

Disease Area Specialist – Clinical Trial & Pipeline

Company: Bristol Myers Squibb
Location: Mumbai, Maharashtra, India
Job Type: Full-time
Work Model: Head Office (20–30% Field-based)
Job ID: R1602160


Role Summary

The Disease Area Specialist (DAS) represents the medical and scientific leadership for assigned pipeline assets within the Therapy Area (TA). The role acts as a key scientific partner who drives medical strategy, supports clinical development, and ensures successful execution of clinical trial programs in alignment with global and country-level objectives.

The DAS plays a critical role in translating global pipeline strategy into local execution while ensuring strong collaboration across Medical Affairs, Clinical Operations, Regulatory, Market Access, and Commercial functions.


Key Responsibilities

1. Medical & Pipeline Strategy

  • Align country medical activities with global pipeline (WW) strategies.

  • Implement Therapy Area initiatives in line with global medical plans.

  • Participate in Early Product Planning (EPP) and global/regional pipeline forums.

  • Drive India-level strategy for pipeline assets.


2. Clinical Development Leadership (Phase I–III)

  • Provide medical input into:

    • Clinical Development Plans

    • Protocols

    • Concept Sheets

    • Feasibility Assessments

  • Ensure scientific and operational excellence in clinical trials.

  • Support design and execution of studies across all phases.


3. Clinical Trial Feasibility & Start-up

  • Lead country feasibility assessments for clinical trials.

  • Evaluate:

    • Epidemiology

    • Patient Journey

    • Treatment Landscape

    • Site Capability

    • Payer Environment

    • Competitive Trials

  • Support trial start-up and recruitment strategies.

  • Identify risks and implement mitigation plans for timelines.


4. Key Opinion Leader (KOL) Engagement

  • Engage with Key Opinion Leaders and scientific experts.

  • Build scientific advocacy for pipeline assets.

  • Collect insights to support:

    • Clinical trial design

    • Development strategy

    • Medical planning


5. Clinical Trial Execution Support

  • Provide medical support during trial conduct.

  • Serve as primary medical contact for investigators and sites.

  • Resolve medical/scientific queries and escalate issues to global teams.


6. Training & Scientific Support

  • Deliver training on:

    • Protocols

    • Disease areas

    • Risk Management Plans (RMPs)

  • Train:

    • CRAs

    • Investigators

    • Site teams

    • MSLs

    • Internal stakeholders


7. Regulatory & Ethics Support

  • Support:

    • IEC/IRB submissions

    • CTA filings

    • NDA discussions

    • Label discussions

    • Ministry of Health interactions

  • Ensure compliance with regulatory requirements.


8. Pharmacovigilance & Safety

  • Review and assess:

    • AEs (Adverse Events)

    • SAEs (Serious Adverse Events)

  • Support Patient Safety team with:

    • Medical evaluations

    • Risk-benefit analysis

    • Follow-ups


9. Audit & Compliance

  • Support:

    • GCP audits

    • Regulatory inspections

  • Ensure adherence to:

    • ICH-GCP guidelines

    • Local regulations

    • Company policies


10. Cross-Functional Collaboration

Collaborate with:

  • Market Access

  • HEOR

  • Regulatory Affairs

  • Commercial Teams

  • Clinical Operations

  • Global Development Teams


11. Evidence Generation & RWE

  • Utilize:

    • Real-World Evidence (RWE)

    • Registries

    • Epidemiology data

  • Support:

    • Study design innovation

    • Access strategy

    • Pipeline value demonstration


12. Capability Building

  • Train and mentor:

    • MSLs

    • Sales & Marketing teams

    • New joiners

  • Strengthen scientific knowledge across teams.


Role Qualifications

Education

  • MBBS / MD (preferred)


Experience

  • 3–4 years experience in:

    • Medical Affairs

    • Clinical Development

    • Pharmaceutical industry

  • Experience in clinical trial support preferred.