Overview

Bioplus Life Sciences is seeking an experienced Medical Affairs specialist to lead end-to-end Medical Affairs / Translational Medicine for multiple NCEs under development targeted at submissions across DCGI, USFDA, and EMA. This position will focus on shaping the scientific narrative and market readiness for novel compounds from the "proof-of-concept" stage through global registration.

Summary

Key Responsibilities

• Lead clinical development plans for assigned compounds/indications, aligned with overall program and regulatory strategy
• Lead clinical study design, including concepts, synopses, protocols, eligibility criteria, endpoints, schedules of assessment, and feasibility
• Partner with Clinical Operations and CROs on compliant study conduct, including enrolment planning, issue escalation, oversight, timelines, and quality
• Review clinical data on an ongoing basis, support medical/scientific interpretation, and contribute to risk–benefit assessments and decision-making
• Lead the authoring, review, and QC of protocols, IBs, CSRs, annual reports, briefing books, IND/CTA sections, and responses to ECs/health authorities
• Collaborate with Biostatistics and Data Management on CRF/eCRF review, data-review conventions, analysis planning input, and interpretation of outputs
• Mentor junior team members on clinical development processes, documentation standards, and cross-functional ways of working
• Establish early-stage partnerships with global scientific leaders and academic consortia to gather insights on unmet needs and pilot new diagnostic or monitoring technologies
• Collaborate with Clinical Development to optimize protocol designs, endpoint selection, and patient recruitment strategies based on clinical practice patterns
• Establish the medical information infrastructure and train field-based Medical Science Liaisons (MSLs) on the NCE's complex mechanism of action

Skills Required

• Deep knowledge of regulatory guidelines (GCP, FDA, EMA, CDSCO), publication planning, and the specific therapeutic area relevant to the NCE
• Demonstrated experience supporting interventional clinical studies across protocol development, execution, and reporting
• Proven ability to work cross-functionally with Clinical Operations, Regulatory, Biostatistics, Safety, Medical Writing, and external vendors
• Strong understanding of ICH-GCP, protocol design, clinical documentation, and regulatory interactions, scientific writing, data review, and communication skills, with the ability to translate program goals into study-level actions
• Ability to thrive in a mid-size, fast-moving biotech with a high degree of ownership and adaptability
• Experience in one or more relevant therapeutic areas (e.g., Ophthalmology, Hepatology, Autoimmune, Anti-inflammatory)
• Experience contributing to IND, CTA, NDA, BLA, or MAA-supporting materials