The clinical lead will work with the senior clinical Lead and the Head of clinical function to design the clinical development plan and finalize the development strategy for Phase II and Phase III trials.

Prepare for discussions with the KoLs / Agencies and seek opinion on overall clinical development strategy. Communicate with CROs, investigators to support enrolment and responsible for medical monitoring.

Key responsibility of the role.

• Reviews scientific literature to optimize the clinical development plan and identifies most efficient design

• Supports for drafting the dossier for the EoP2(End of Phase 2) meeting and to open an IND with the US FDA. Reviews study documents: IB, protocol, study plans

• Training the study team, study sites at IM and/or SIVs, addressing medical queries from sites, IRBs and regulatory agencies, and review of interim data

• Identifies the questions to discuss with the regulatory agencies (US-FDA, EMA etc) and prepares company position to finalize the briefing package

• Interacting with Key Opinion Leaders and seek advice on the development plan

• Developing a Clinical Development Plan and strategy for the Dermatology and Immunology indications such as atopic dermatitis, psoriasis, alopecia areata, vitiligo, etc.

1 - 6 years in related field for Phase ll and lll studies

1+ years of work experience with Clinical Development · Doctor of Medicine · 1+ years of work experience with Clinical Research