Medical Director

• Contribute to the overall clinical development strategy for assigned programs.
• Partner with the Executive Medical Director to define clinical development plans, trial designs, and program milestones.
• Provide medical and scientific input into target product profiles, study protocols, investigator brochures, and regulatory documents.
• Maintain awareness of internal and external developments (scientific, clinical, competitive, and regulatory) that could impact the development plan, including attendance at major scientific conferences, participation in competitive intelligence activities, and periodic literature review.
• Critically evaluate available information about diseases of interest to the therapeutic area and the competitive landscape and synthesize information succinctly to support dissemination and incorporation into clinical development programs, asset plans and therapeutic area strategy
• Help to determine appropriate advisory boards experts
• Serve as medical monitor for clinical trials, ensuring subject safety and data integrity.
• Provide clinical guidance to operational teams, investigators, and external partners.
• Review and interpret clinical data, prepare clinical study reports, and support publication activities.
• Be responsible for the clinical content of all clinical and regulatory documents, including protocols, INDs, CTAs, investigator brochures, CRFs, annual IND reports, CSRs, and clinical expert reports
• Organize and present at relevant clinical advisory boards, DMC and medical/scientific meetings
• Collaborate with Clinical Operations, Regulatory Affairs, Biostatistics, Pharmacovigilance, and Medical Affairs to ensure seamless execution of clinical programs.
• Represent Clinical Development in internal governance meetings and cross-functional program teams.
• Support business development and alliance management activities as needed.
• Contribute to regulatory submissions (INDs, NDAs, BLAs, etc.) and interactions with global health authorities.
• Ensure compliance with GCP, ICH guidelines, and company SOPs.
• Prepare abstracts and manuscripts for publication/presentation.
• Present clinical data to internal stakeholders, investigators, and at scientific conferences.
• Provide mentorship to junior medical or scientific staff.

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