Associate Director, Clinical Development & Operations

About the role

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, and driving activities to meet or exceed timelines and milestones.

Responsibilities

• Clinical Study Management:
  • Direct and manage complex bioequivalence studies from beginning to end.
  • Define clinical study project scope, goals, and deliverables in collaboration with key internal and external stakeholders.
  • 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.
  • Provide prompt inter-departmental communication to provide clinical supplies to meet clinical trial schedules and timelines.
• Measurement:
  • Ensure key clinical trial project tasks and milestones are completed on time.
  • Manage each project stage and overall budget to plan; escalate budgetary deviations for review.
  • Ensure all documents are written, reviewed, and approved within agreed time frames; changes are approved and notified to all relevant recipients.
• Leadership in ideas to launch process:
  • Collaborate with internal and external resources to achieve best outcomes.
  • Effectively communicate clinical trial progress and status to key stakeholders in a timely and clear fashion.
  • Identify and resolve issues/conflicts with 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 and Functional Managers.
  • Delivery and timely submission of all US, EU, UK, and MENA submissions.
• Planning, Reporting and Process Improvement:
  • Develop full-scale clinical trial project plans and associated communications documents and tracking tools.
  • Estimate resources and participants needed to achieve project goals.
  • Draft 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 to identify successful and unsuccessful factors.
  • Present portfolio statistics to gatekeepers and recommend corrective actions.
  • Act as a team member for process improvement/simplification.
• Measurement:
  • Ensure timely completion of all reporting and associated administrative requirements.
  • Maintain accuracy of budgets prepared and actual realized.
  • Table continuous improvement initiatives.
  • Identify and escalate poor performance to appropriate level of management.
• Relationships:
  • Maintain an environment of cooperation and teamwork.
  • Interface with all related functions and teams as required.
  • Serve as liaison for the clinical trial project in certain aspects of clinical research with key internal and external contractors, clients, or business partners.
• Measurement:
  • Feedback from key stakeholders, internal and external subject matter experts.
  • Ensure communication and documents are accurate and distributed in a timely manner to relevant recipients.
  • Proactively manage and resolve conflicts that may arise.
• Health, Safety and Security of data:
  • Ensure adherence to all environmental, health, and safety guidelines and procedures to protect employees and provide a safety-focused work environment.
  • Ensure 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 GCPO.
  • Other duties as assigned.

Qualifications

• Bachelor’s degree in a scientific discipline with a minimum of 12 years of experience in clinical study management/oversight (generic pharmaceutical industry preferred) and/or a technical role demonstrating knowledge of the development process of complex dosage forms within the pharmaceutical industry; OR
• Master’s degree in a scientific discipline with a minimum of 10 years of experience in clinical study management/oversight (generic pharmaceutical industry preferred) and/or a technical role demonstrating knowledge of the development process of complex dosage forms within the pharmaceutical industry; OR
• Ph.D. in pharmaceutical sciences with a minimum of 8 years of experience in clinical study management/oversight (generic pharmaceutical industry preferred) and/or a technical role demonstrating knowledge of the development process of complex dosage forms within the pharmaceutical industry.
• Excellent verbal and 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.

Benefits

• Annual performance bonus, commission, and share potential.
• Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 4% of eligible pay; Hikma will match 100% of the first 6% of eligible pay that you contribute.
• Generous paid time off (PTO) bank starting with 20 days (prorated based on hire date); additional days granted upon reaching work milestone anniversaries.
• 3 personal days (prorated based on hire date).
• 11 company-paid holidays.
• Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits.
• Employee discount program.
• Wellbeing rewards program.
• Career advancement and growth opportunities.
• Tuition reimbursement.
• Paid maternity and parental leave (eligibility requirements apply).