Job Purpose
Job Description – Clinical Development & Medical Affairs
Lead Global Clinical Development, Medical Affairs, Pharmacovigilance, Clinical Project Management, Clinical Data Management, Medical Writing, and Biostatistics. Drive global clinical and medical strategies, ensure regulatory compliance, and support clinical development across the product lifecycle.
Key Responsibilities
Strategic Leadership
- Lead and guide the Clinical Development, Medical Affairs, Pharmacovigilance, Clinical Data Management, Medical Writing, Biostatistics, and Clinical Project Management teams.
- Work closely with senior leadership to achieve business and organizational goals.
Clinical Development
- Oversee global clinical development activities for biologics, generics, and discovery programs (as applicable).
- Coordinate Phase I–IV clinical trials, post-marketing studies, investigator-initiated studies, and real-world evidence programs.
- Ensure compliance with ICH-GCP and global regulatory requirements.
- Build and maintain strong relationships with investigators and clinical trial sites.
Medical Affairs
- Lead Medical Affairs, Scientific Communications, Medical Information, Medical Writing, Clinical Data Management, and Biostatistics activities.
- Review and approve clinical protocols, study reports, publications, and scientific documents.
Pharmacovigilance
- Oversee global pharmacovigilance activities across regulated and emerging markets.
- Ensure compliance with global drug safety regulations, signal detection, risk management, aggregate reporting, and inspection readiness.
- Review safety data and support regulatory inspections and audits.
Clinical Project Management
- Oversee clinical project planning, budgeting, resource allocation, vendor management, clinical quality, and project governance.
- Monitor project timelines, quality, risks, and deliverables to ensure projects are completed on time and within budget.
Qualification
Experience
- 18–25+ years of experience in Clinical Development, Medical Affairs, Pharmacovigilance, and Clinical Research.
- Experience in biologics, biosimilars, generics, or specialty pharmaceuticals.
- Strong leadership experience in managing cross-functional global teams.
