Associate Director, Clinical Development & Operations

Hikma Pharmaceuticals USA Inc.•Columbus, OH

5d•Onsite

About The Position

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.

Requirements

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.

Nice To Haves

Generic pharmaceutical industry is preferred
technical role which demonstrates a knowledge of the development process of complex dosage forms within the pharmaceutical industry preferred

Responsibilities

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.
Lead and support any regulatory needs from 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.
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.
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.

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
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
Career advancement and growth opportunities
Tuition reimbursement
Paid maternity and parental leave