Strategic Lead, Clinical Development & Operations

RXinsider LTD.; Columbus, Northern (OH, KY); Hybrid; USD 130,000 - 180,000; Full time

Job summary

Hikma Pharmaceuticals USA Inc. in Columbus, OH seeks an Associate Director of Clinical Development & Operations to lead end‑to‑end bioequivalence studies, managing internal and external resources to meet timelines and budgets.

The role emphasizes strategic planning, stakeholder collaboration, and proactive problem solving across multiple regions. The candidate will oversee clinical study management, maintain delivery milestones, and drive process improvements while liaising with regulatory

Qualifications

• Bachelor’s degree in scientific discipline with extensive experience in clinical study management/oversight.
• Master’s degree with substantial clinical study management experience.
• Ph.D. in pharmaceutical sciences with relevant oversight experience is preferred.

Responsibilities

• Direct and manage complex Bioequivalence studies from start to finish within budget and timelines.
• Define study scope, goals and deliverables in collaboration with stakeholders.
• Lead regulatory interactions and ensure timely, compliant submissions across US, EU, UK and MENA.

Skills

Project management

Bioequivalence knowledge

Communication skills

Education

Bachelor’s degree in scientific discipline

Master’s degree in scientific discipline

Ph.D. in pharmaceutical sciences

Job description

Hikma Pharmaceuticals USA Inc. in Columbus, OH seeks an Associate Director of Clinical Development & Operations to lead end‑to‑end bioequivalence studies, managing internal and external resources to meet timelines and budgets.

The role emphasizes strategic planning, stakeholder collaboration, and proactive problem solving across multiple regions. The candidate will oversee clinical study management, maintain delivery milestones, and drive process improvements while liaising with regulatory