Global Development Scientist, Clinical Development

Overview

Provide scientific and clinical input to late-stage product development and AI-assisted ways of working, including building, delivering and analyzing pivotal clinical trials in respiratory and immunology. The role also leads selected AI-enabled use cases in Respiratory Clinical Development.

What you'll do

• Provide scientific leadership in the innovative design, execution and interpretation of clinical trials in one or more development programs.
• Be involved primarily in late stage (Phase IIb and Phase III) clinical programs, collaborating with clinical colleagues supporting early-stage programs and 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 success measures with study and functional partners.
• Support and contribute to medical monitoring of trials.
• Lead activities that ensure quality, consistency and integration of clinical study deliverables and the safety evaluation process within the clinical team.
• Provide clinical leadership for testing and validation of AI-assisted outputs, ensuring human review, traceability, data quality, privacy, security and compliance.
• Ensure scientific input to TA standards and provide scientific evidence to support strategic decision making for R&D, marketing, clinical and business development.
• 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.

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).
• 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 the principles of GCP.

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 to clinical and scientific audiences.
• Experience with regulatory submissions, life cycle management, advisory boards and 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, with a minimum of three days per week from the office on average.
• Total years of experience: 10 to 15 years.
• Career level: E.