Associate Director, Clinical Development & Operations

Job Title: Associate Director, Clinical Development & Operations
Location: Columbus, OH
Job Type: Full time
Req : 12385

As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates’ mission is to bring Better Health. Within Reach. Every Day. for millions of patients around the world. We are a trusted, reliable partner and dependable source of over 800 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe.

Through our 32 manufacturing plants, eight R&D centers, and 9,500+ employees worldwide, we are always hard at work creating high-quality medicines and making them accessible to the people who need them.

We are committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds. We are seeking a talented and motivated Associate Director, Clinical Development & Operations to join our team.

In this role, you will be responsible for leading project plan development for clinical research for multiple complex bioequivalence studies. Managing internal and external resources including subject matter experts, vendors, and driving activities to meet or exceed timelines and milestones. Identifying obstacles that may negatively impact clinical trial progress and ideate viable options to maintain project advancement.

• Direct and manage complex Bioequivalence studies from beginning to end. Responsible and accountable for the delivery of project milestones and maintaining timelines to successful outcomes according to the approved business case on time, expected quality and within budget.
• Lead with defining clinical study project scope, goals and deliverables that support business goals in collaboration with key internal and external stakeholders on an on-going basis.
• Identify and manage clinical study project dependencies and critical path for multiple complex bioequivalence studies
• Proactively manage changes in project scope, identify potential crises, and devise contingency plans.
• Communicate with regulatory agencies on clinical study designs and strategies.
• Prompt inter-departmental communication to provide clinical supplies to meet clinical trial schedule and timeline

• Key clinical trial project tasks and milestones are completed on time. Each project stage and overall budget is managed to plan with the expectation that any budgetary deviations are escalated for review.
• All documents are written, reviewed and subsequently approved with agreed time frames. Changes are approved and notified to all relevant recipients.

• Collaborates with internal and external resources to achieve best outcomes.
• Effectively communicates clinical trial progress and status to key stakeholders in a timely and clear fashion.
• Identify and resolve issues/conflicts with the clinical research trial project key resources.
• Proactively manage changes in project scope, identify potential crises, and devise contingency plans.
• Lead and support any regulatory needs from US, EU, UK and MENA submissions

• Delivery in full and on time for business requirements.
• Feedback from Senior Management, Functional Managers
• Delivery and timely manner submission of all US, EU, UK and MENA submissions

• Lead with the development of full-scale clinical trial project plans and associated communications documents, and tracking tools.
• Estimate the resources and participants needed to achieve project goals.
• Lead with drafting the budget proposals and recommend subsequent budget changes where necessary.
• Track clinical trial project milestones and deliverables.
• Develop and deliver progress reports, proposals, requirements documentation and presentations
• Support clinical trial project post-mortems and help create a recommendation report in order to identify successful and unsuccessful factors of the clinical trial.
• Present portfolio statistics to the gatekeepers and recommend corrective actions. Communication is clear, comprehensive and correct.
• Act as a team member for process improvement/simplification

• Ensure timely completion of all reporting and associated administrative requirements.
• Accuracy of budgets prepared and actual realized.
• Continuous improvement initiatives tabled.
• Poor performance…