Job Title: Associate Director, Clinical Development & Operations
Location: Columbus, OH
Job Type: Full time
Req ID: 12385
Description:
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.
Key Responsibilities:
Clinical Study Management:
- 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
Measurement:
- 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.
Leadership in ideas to launch process
- 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
Measurement:
- 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
Planning, Reporting and Process Improvement
- 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
Measurement:
- Ensure timely completion of all reporting and associated administrative requirements.
- Accuracy of budgets prepared and actual realized.
- Continuous improvement initiatives tabled.
- Poor performance identified and escalated to appropriate level of management.
Relationships
- Maintain an environment of cooperation and teamwork.
- Interface with all related functions and teams as required.
- May serve as liaise for the clinical trial project in certain aspects of clinical research project with key internal and external contractors, client or business partners.
Measurement:
- Feedback from key stakeholders, internal and external subject matter experts.
- Communication and documents are accurate and distributed in a timely manner to the relevant recipients.
- Able to proactively manage and resolve conflicts that may arise.
Health, Safety and Security of data
- Ensure that in all circumstances, there is adherence to all environmental, health and safety guidelines and procedures in an effort to protect employees and to provide a work environment that is safety-focused.
- Ensure that any data generated by Hikma sponsored trials is well-protected and properly communicated
Measurement:
- No preventable accidents, no lost time injuries
- Compliance with data management in GCP
- Other duties as assigned
Qualifications:
We value the skills and experiences candidates bring to the table. While we have listed some qualifications below, we encourage candidates to apply even if they do not meet all of them:
- Bachelor’s degree in scientific discipline with a minimum of 12 years of experience in clinical study management/oversight (Generic pharmaceutical industry is preferred) and/or a technical role which demonstrates a knowledge of the development process of complex dosage forms within the pharmaceutical industry preferred; OR
- Master’s degree in scientific discipline with a minimum of 10 years of experience in clinical study management/oversight (Generic pharmaceutical industry is preferred) and/or a technical role which demonstrates a knowledge of the development process of complex dosage forms within the pharmaceutical industry preferred; OR
- Preferred Ph.D., in pharmaceutical sciences with a minimum of 8 years of experience in clinical study management/oversight (Generic pharmaceutical industry is preferred) and/or a technical role which demonstrates a knowledge of the development process of complex dosage forms within the pharmaceutical industry preferred
- Excellent verbal/written communication skills.
- Demonstrated knowledge and experience in Project Management
- Solid understanding of US FDA and EMA Bioequivalence requirements
- Demonstrated knowledge and thorough understanding of GMP, GLP, GCP and FDA requirements for drug product development, process development and commercialization.
- Demonstrated experience with managing a budget and developing resource plans.
Equal Opportunity Employer:
Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law.
