Summary

The Manager / Senior Manager – Clinical Development supports 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
• Support inspection and audit readiness, ensuring documentation and conduct meet ICH-GCP, SOPs, and applicable regulations
• Contribute to budget, resource, and timeline planning for assigned studies or workstreams
• Mentor junior team members on clinical development processes, documentation standards, and cross-functional ways of working.

Skills Required

• 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
• Strong 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)
• Exposure to India clinical trial submissions, EC processes, and India based CROs
• Experience contributing to IND, CTA, NDA, BLA, or MAA-supporting materials
• Prior experience in a matrixed biotech environment supporting both strategic and operational aspects of development.

Core Competencies Clinical trial design awareness; scientific and medical judgment; cross-functional stakeholder management; protocol and document review; clinical data review and interpretation; planning and prioritization; vendor/CRO oversight; communication and presentation skills; quality and compliance mindset; problem-solving under ambiguity.