Title:  Sr. Scientist, Clinical R&D

Hikma Pharmaceuticals’ purpose is to put better health, within reach, every day for millions of patients around the world. Through our global footprint of 30+ manufacturing plants, 8+ R&D centers, and 9,000+ empowered employees, we are committed to making high-quality medicines accessible to the people who need them.

We are hiring a Sr. Scientist in Clinical R&D on-site in Zagreb, Croatia and this position is a unique opportunity to be involved in clinical development programs. In this role you will be given the freedom to handle a wide variety of tasks as part of Clinical R&D with Hikma Pharmaceuticals US Inc. But also, in more general terms, Hikma offers an exciting opportunity to contribute and grow.

Sr. Scientist, Clinical R&D

Location: Zagreb

Key Responsibilities:

• Assist with defining the scope of clinical trial projects within Hikma RX, responsible for the quality design of clinical trials demonstrating bioequivalence or bio similarity, including:
  • Vendor Selection and Contract Initiation
  • Estimate the resources and participants needed to achieve project goals
  • Protocol, Case Report Form, Informed Consent review and approval
  • Review of Preliminary Data and final Clinical Study Reports
  • Provide Sponsor Oversight of Clinical Trials
• Build, develop and grow any business relationships vital to the success of the portfolio.
• Provide prompt inter-departmental communication to provide clinical supplies to meet critical timelines.
• Effectively communicates clinical trial progress and status to key stakeholders in a timely and clear fashion.
• Identify and resolve issues/conflicts and potential barriers determining appropriate solutions and utilizing resources to drive improvements with the clinical research trial project key resources.
• Assist 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, and presentations.
• Support clinical trial project post-mortems and make recommendations regarding successful and unsuccessful factors of the clinical trial.
• Assures optimal and efficient development of clinical trials within project timelines and budget, with delivery of regulatory documents for submissions in compliance with high quality and regulatory requirements of global markets (US, EU, Jordan, Canada).
• Keeps current in technologies and regulatory guidance’s best practices and their implementation to support company strategy.
• Effectively enables strong collaboration within multi-disciplinary teams at a local and global company level.
• Maintain an environment of cooperation and teamwork.

What We Expect:

• Bachelor’s, Master’s, or advanced degree in scientific or technical discipline preferred; Relevant experience and certifications considered a plus.
• At least 5 years of experience in project management (any industry) and/or a technical role which demonstrates a knowledge of the development process within the pharmaceutical industry preferred; in lieu of pharmaceutical industry, experience in highly regulated industry required. 
• Excellent presentation skills, meeting facilitation skills, verbal and written communication skills
• Demonstrated knowledge and experience in Project Management and Clinical Trial Monitoring
• Ability to influence others by presenting alternative options persuasively
• Demonstrated knowledge of clinical trial data analytics preferred
• Solid understanding of Manufacturing, Research & Development and Quality Operations
• Demonstrated ability/experience in the preparation of ANDA documentation (authoring and compilation of Module 2.7 & Module 5 documents)
• Understanding of ICH GCP E6 (R3) and EU & FDA requirements for clinical research.
• Understanding of budget and resource planning.
• Effectively processes thoughts quickly and accurately from one project to another
• Fluency in English language (spoken and written)
• Willingness to travel to Columbus, OH, global locations of CROs and clinical research sites

What We Offer:

• Collaboration across teams and functions, building relationships with colleagues from different departments and regions
• A dynamic international work environment that values curiosity, growth, and innovation
• Permanent full-time position
• Competitive compensation package
• Annual health check-up and incident insurance policy
• Monthly food and travel allowances
• Free drinks, fruit and parking slot
• Opportunities for travel

If you are collaborative, like to innovate in the way you work, care about others, and are interested in a career where you can make a positive impact on people’s lives, please send your English CV via the application link.