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
Bristol Myers Squibb
3-4 years
preferred by company
Mumbai, India
1 May 13, 2026
Job Description
Job Type: Hybrid Education: M.Pharm/B.Pharm or M.Sc. Skills: ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment

Job Title: Disease Area Specialist – Clinical Trial & Pipeline

Location: Mumbai, Maharashtra, India
Job Type: Full-Time (Hybrid / Head Office + Field-Based)
Experience Required: 3–4+ Years (Freshers are not eligible)
Industry: Medical Affairs / Clinical Development / Pharmaceuticals / Clinical Research / Oncology / Specialty Medicine / Life Sciences
Department: Medical Affairs / Clinical Development / Pipeline Strategy

About the Role
We are seeking a highly strategic and medically accomplished Disease Area Specialist – Clinical Trial & Pipeline to support clinical development strategy, pipeline medical affairs, and country-level trial leadership for innovative pharmaceutical therapies. This high-impact role is ideal for professionals with expertise in medical affairs, clinical development, clinical trial strategy, KOL engagement, pipeline planning, pharmacovigilance, and regulatory medical support.

The ideal candidate will drive medical strategy for pipeline assets, lead country-level clinical trial execution from a medical perspective, support regulatory and scientific engagement, and collaborate with global and local stakeholders to accelerate clinical innovation and patient access.

This opportunity is highly suited for experienced medical professionals seeking strategic growth in pharmaceutical medical affairs and clinical development leadership.

Key Responsibilities

Pipeline Medical Strategy & Clinical Development Leadership

  • Lead country-level medical strategy for pipeline and developmental assets aligned with global clinical development priorities.
  • Translate worldwide medical and pipeline strategies into locally relevant clinical and scientific execution plans.
  • Support Early Product Planning (EPP) activities and represent country medical teams in regional and global pipeline strategy discussions.
  • Monitor therapeutic landscapes, clinical evidence evolution, unmet medical needs, and competitor developments to shape strategic pipeline positioning.

Clinical Trial Leadership & Trial Execution Support

  • Provide strategic and tactical medical leadership for Phase I–III clinical trials across assigned therapeutic areas.
  • Support development of clinical trial strategies including protocol review, feasibility planning, concept development, and operational readiness.
  • Lead country feasibility assessments through epidemiology analysis, treatment landscape review, physician engagement, and patient journey evaluation.
  • Support clinical trial startup, recruitment planning, site readiness, and proactive risk mitigation strategies.

Medical Support for Clinical Operations & Site Engagement

  • Act as the primary medical point of contact for investigators, study sites, and clinical stakeholders during trial conduct.
  • Resolve medical and clinical issues during trial execution and escalate complex matters appropriately.
  • Deliver training on protocols, Risk Management Plans (RMPs), disease area knowledge, and study procedures to investigators, CRAs, and site teams.
  • Represent the organization at investigator meetings, scientific forums, and study engagement activities.

KOL Engagement & Scientific Advocacy

  • Build strong relationships with Key Opinion Leaders (KOLs), scientific experts, investigators, and healthcare professionals.
  • Gather scientific insights to inform pipeline development, clinical strategy, and local evidence planning.
  • Strengthen medical advocacy through high-value scientific dialogue and expert collaboration.

Regulatory, Compliance & Health Authority Support

  • Provide medical support for IEC/IRB interactions, Clinical Trial Applications (CTAs), NDA meetings, labeling discussions, regulatory submissions, and Ministry of Health interactions.
  • Support regulatory inspections, internal GCP audits, and compliance governance activities.
  • Ensure all clinical trial activities align with ICH-GCP guidelines, local regulations, internal SOPs, and global compliance standards.

Pharmacovigilance & Medical Safety Support

  • Conduct local AE/SAE medical review for development compounds.
  • Support patient safety teams with adverse event follow-up, medical assessments, and benefit-risk evaluations.
  • Provide pharmacovigilance expertise across developmental clinical programs.

Cross-Functional Medical Collaboration

  • Partner closely with Clinical Operations, Regulatory Affairs, Market Access, HEOR, Medical Science Liaisons (MSLs), Commercial, and Payer teams.
  • Support evidence generation strategies using real-world evidence (RWE), epidemiology insights, registries, and innovative clinical designs.
  • Contribute medical expertise to regulatory and commercial decision-making processes.

Training, Mentorship & Medical Capability Building

  • Deliver scientific and disease-area training to internal stakeholders including MSLs, field medical teams, commercial teams, and new team members.
  • Support medical capability building and continuous knowledge development across teams.

Required Qualifications

  • MBBS mandatory; MD strongly preferred.
  • Minimum 3–4+ years of relevant experience in pharmaceutical medical affairs, clinical development, clinical research, or specialty medical roles.
  • Strong understanding of clinical development, ICH-GCP, clinical trial execution, medical affairs strategy, and regulatory medical processes.
  • Experience supporting or leading clinical trials from a medical or clinical development perspective.
  • Strong expertise in KOL engagement, scientific communication, pipeline strategy, and clinical stakeholder management.
  • Ability to manage complex clinical, medical, and operational decision-making scenarios.
  • Strong written and spoken English communication skills.
  • Ability to work across therapeutic areas and rapidly adapt to evolving scientific environments.