Welcome Back

Google icon Sign in with Google
OR
I agree to abide by Pharmadaily Terms of Service and its Privacy Policy

Create Account

Google icon Sign up with Google
OR
By signing up, you agree to our Terms of Service and Privacy Policy
Instagram
youtube
Facebook

Disease Area Specialist, Clinical Trial & Pipeline

Bristol Myers Squibb
3-4 years
Not Disclosed
Mumbai, India
1 June 2, 2026
Job Description
Job Type: Full Time Education: MBBS/MD Skills: Medical Coding, Medical Terminology, mRS and EQ-5D-5L., Narrative Writing

Disease Area Specialist, Clinical Trial & Pipeline

Company: Bristol Myers Squibb
Job ID: R1602160
Location: Mumbai
Employment Type: Full-Time
Department: Medical Affairs / Clinical Development
Work Model: Head Office Based (20–30% Field Travel)


Role Summary

The Disease Area Specialist (DAS), Clinical Trial & Pipeline serves as a key medical leader responsible for driving pipeline strategy, clinical development activities, and scientific engagement for developmental assets within India.

The role works closely with Medical Affairs, Clinical Operations, Regulatory Affairs, Market Access, Commercial, Patient Safety, and external scientific experts to ensure successful execution of clinical development plans and alignment with global medical strategies.


Key Responsibilities

Pipeline Strategy & Medical Leadership

  • Align country medical activities with global pipeline and therapy area strategies.

  • Participate in Early Product Planning (EPP) processes.

  • Represent India in regional and global pipeline working groups.

  • Lead medical strategy development for assigned pipeline assets.

  • Monitor:

    • Competitive landscape

    • Emerging clinical evidence

    • Treatment guidelines

    • Unmet medical needs

  • Translate global pipeline insights into local medical strategies.


Clinical Development & Trial Management

  • Provide medical leadership for Phase I–III clinical trials.

  • Support:

    • Clinical development plans

    • Concept sheets

    • Protocol development

    • Feasibility assessments

  • Collaborate with Regional Clinical Operations (RCO) teams.

  • Lead country-level feasibility evaluations.

  • Support trial startup, recruitment planning, and enrollment strategies.

  • Identify risks and implement mitigation plans to maintain timelines.


Medical & Scientific Engagement

  • Build relationships with Key Opinion Leaders (KOLs) and scientific experts.

  • Gather medical insights to inform pipeline and clinical development strategies.

  • Act as the primary medical contact for investigators and study sites.

  • Resolve local medical issues and escalate when necessary.

  • Represent the company at:

    • Investigator meetings

    • Scientific congresses

    • Medical forums


Training & Scientific Education

  • Deliver training on:

    • Protocols

    • Risk Management Plans (RMPs)

    • Disease areas

  • Train:

    • CRAs

    • Clinical teams

    • Investigators

    • Site personnel

  • Provide ongoing scientific education to:

    • Medical Science Liaisons (MSLs)

    • Sales teams

    • Marketing teams

    • New employees


Regulatory & Compliance Support

  • Provide medical support for:

    • IEC/IRB interactions

    • Clinical Trial Applications (CTAs)

    • NDA discussions

    • Label negotiations

    • Ministry of Health engagements

  • Support regulatory inspections and GCP audits.

  • Ensure compliance with:

    • ICH-GCP guidelines

    • Local regulations

    • Internal policies


Pharmacovigilance & Patient Safety

  • Review local AE/SAE reports for development compounds.

  • Support Patient Safety teams with:

    • Medical assessment

    • Follow-up activities

    • Risk-benefit evaluations

  • Provide pharmacovigilance expertise throughout clinical development.


Cross-Functional Collaboration

  • Work closely with:

    • Market Access

    • HEOR

    • Regulatory Affairs

    • Commercial teams

    • Payer stakeholders

  • Contribute medical expertise to:

    • Regulatory submissions

    • Market access strategies

    • Evidence generation plans

  • Utilize:

    • Real-World Evidence (RWE)

    • Registries

    • Epidemiology data


Required Qualifications

Education

Preferred:

  • MBBS

  • MD

Experience

  • 3–4 years of experience in:

    • Medical Affairs, and/or

    • Clinical Development within the pharmaceutical industry

Technical Knowledge

  • Strong understanding of:

    • Clinical Development

    • ICH Guidelines

    • Good Clinical Practice (GCP)

    • Pharmacovigilance

    • Clinical Trial Operations