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Disease Area Specialist, Clinical Trial & Pipeline

Bristol Myers Squibb
3-4 years
Not Disclosed
Mumbai, Navi Mumbai, India
10 June 3, 2026
Job Description
Job Type: Full Time, Hybrid, Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Clinical Trials, Detail-Oriented, Drug Development, Lifesciences, Negotiation Skills, Regulatory Compliance, Communication Skills, CPC Certified, Data Analysis, Document Management, Life Science, Regulatory Compliance, Waterfall Model, GCP guidelines, 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