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

Support the design, planning, execution, and oversight of clinical development activities for assigned pipeline assets. The role bridges clinical strategy and study execution, providing protocol input, cross-functional coordination, medical and scientific review, contribution to regulatory documents, and oversight of study-level deliverables in collaboration with Clinical Operations, Biostatistics, Data Management, Medical Writing, Pharmacovigilance, Regulatory Affairs, and external partners. The position is hands-on and suited to a matrixed, fast-paced biotech environment where scientific rigor and operational excellence are both critical.

Key Responsibilities

• Contribute to clinical development plans for assigned compounds/indications, aligned with overall program and regulatory strategy
• Support 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
• Contribute to 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
• Collaborate with Clinical Development to optimize protocol designs, endpoint selection, and patient recruitment strategies based on clinical practice patterns
• Train Field-Based Medical Science Liaisons (MSLs) on the NCE's complex mechanism of action

Skills Required

• 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
• 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