Associate Director, Clinical Development & Operations

Hikma Pharmaceuticals; Columbus (OH); On-site; USD 150,000 - 190,000; Full time

Benefits offered by this job

Annual performance bonus

401(k) with company match

Paid time off starting at 20 days

Tuition reimbursement

Comprehensive health benefits

Job summary

Hikma Pharmaceuticals USA Inc. in Columbus, OH is seeking an Associate Director, Clinical Development & Operations to lead complex bioequivalence studies and drive clinical program plans end-to-end.

You will coordinate internal and external resources, manage timelines and budgets, and ensure regulatory submissions across US, EU, UK and MENA are executed with rigor.

Qualifications

• Bachelor’s degree in scientific discipline with extensive clinical study management experience.
• Strong knowledge of US FDA and EMA Bioequivalence requirements and GMP/GLP/GCP.
• Experience leading complex clinical studies with cross-functional teams.
• Excellent verbal and written communication and budgeting skills.

Responsibilities

• Direct and manage Bioequivalence studies from start to finish, delivering milestones on time.
• Define study scope, goals and deliverables with internal/external stakeholders.
• Identify dependencies and critical path for multiple studies; manage changes.
• Communicate with regulatory agencies on study designs and strategies.
• Coordinate clinical supplies to meet trial schedules and timelines.

Skills

Project management

Clinical trial management

Bioequivalence knowledge

Regulatory familiarity

GMP/GLP/GCP knowledge

Communication skills

Budgeting

Leadership

Education

Bachelor’s degree in scientific discipline

Master’s degree in scientific discipline

Ph.D. in pharmaceutical sciences

Job description

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

About Us

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.

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.

What We Offer

• 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
• A 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
• Safety and Quality is a top organizational priority
• Career advancement and growth opportunities
• Tuition reimbursement
• Paid maternity and parental leave
• Eligibility requirements apply to some benefits and depend on the job classification, role, and length of employment. Benefits are subject to change as well as specific plan or program terms.

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.