Overview
Provide scientific and clinical input to late-stage product development and AI-assisted ways of working, focused on pivotal clinical trials in the Respiratory therapeutic area, and act as a lead for selected AI-enabled use cases.
What you'll do
- Provide scientific leadership in the design, execution and interpretation of clinical trials in one or more development programs.
- Collaborate across Patient Safety, Regulatory Affairs, Clinical Operations, and early development groups.
- Primarily work on late-stage (Phase IIb and Phase III) clinical programs, collaborating with clinical colleagues on early-stage programs and with medical affairs colleagues.
- Provide expert scientific input into regulatory documents and interactions with regulatory authorities.
- Provide expert scientific review, analysis, and interpretation of data from ongoing studies and the literature.
- Lead development of quality metrics and data review plans for assigned studies.
- Identify and prioritise clinical development activities where AI assistance can add value, define the clinical problem and intended outcome, and agree fit-for-purpose success measures with study and functional partners, including stakeholder alignment, workflow integration, user feedback, training, adoption monitoring and transition from pilot to sustained use.
- Support and contribute to medical monitoring of trials.
- Lead and participate in activities that ensure quality, consistency and integration of clinical study deliverables and ensure the safety evaluation process within the clinical team.
- Provide clinical leadership for the testing and validation of AI-assisted outputs, ensuring appropriate human review, traceability, data quality, privacy, security and compliance with applicable quality and regulatory expectations, embedding fit-for-purpose methods into study and programme workflows.
- Ensure scientific input to TA standards.
- Provide scientific evidence to support strategic decision making for R&D, marketing, clinical, and business development departments.
- Present protocol and scientific results to multidisciplinary teams and key stakeholders.
- Develop and review protocols, informed consent, investigator's brochure and other clinical development documents.
- Organize and analyse data from clinical research to build new hypotheses.
- Support upskilling in AI-enhanced working methods and contribute to AI capability development across Respiratory Clinical Development.
- Engage with AI user networks and cross-functional initiatives to share learning, promote reuse, and scale AI-assisted practices.
What you'll need
- Relevant Bachelor's or Master's degree with experience from clinical development.
- Three or more years of relevant pharmaceutical industry experience (multi-country clinical trials) is required.
- Understanding of scientific and clinical issues related to the design and implementation of clinical trials and interpreting trial results, particularly in respiratory and immunology clinical development.
- Proven ability to work collaboratively in a cross-functional setting.
- Experience particularly in Phase II and Phase III clinical development.
- Experience using AI technologies and building or deploying AI solutions in a work environment, with demonstrated competence applying AI in clinical, biomedical or drug development settings.
- Strong proficiency in daily knowledge work with agentic AI tools, applying appropriate human judgement and oversight.
- Experience working in GCP-compliant environments, and excellent understanding of principles of GCP.
- Total years of experience: 10 to 15 years.
Nice to have
- Proven track record of leading practice change and pioneering new technologies or ways of working, with measurable impact in biomedical, clinical or drug development settings.
- Excellent written and verbal communication skills, with the ability to explain new AI concepts, evidence, benefits and limitations clearly to clinical and scientific audiences.
- Experience with regulatory submissions, life cycle management, advisory boards, annual safety updates.
- Experience working with or implementing governance frameworks related to data and AI solutions.
- Experience in AI method development or in leading the build or deployment of AI solutions, with demonstrated impact in clinical, biomedical or drug development settings.
- Technical expertise in modern AI methodologies and software development skills in Python and/or experience leveraging coding-agent frameworks.
Details
- Location: Manyata Tech Park, Bangalore, India.
- Work type: Hybrid; on average a minimum of three days per week from the office.
- Objectives established by the Global Clinical Program Lead (GCPL) in agreement with the Global Clinical Head (GCH).
- Date posted 23-Oct-2026; closing date 10-Nov-2026.
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