At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives.
Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organization: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organization that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.
That’s our vision. We’re driven by it. And we need talented people who share it.
If you’re as driven as we are, join us. You’ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry.
• Leads the Clinical Development (CD) Team, a cross functional, multinational team of internal experts, through clinical phase II – III trials through global product registration, as well as supporting product life cycle optimization. Sets project-related objectives with Global Project Team (GPT) members and provides input to their annual performance evaluation (PMP completed by the functional line manager). Requests CD team members and clarifies resource availability with global functional heads
.• Member of the Global Project Team and member of the Global Brand team, representing CD
• In consultation with relevant key disciplines, prepares the Clinical Development Plan (CDP), including an operational plan with high level resource planning (timelines, budget and manpower). Responsible for planning and managing the clinical timelines, managing clinical budget (external clinical grants and CRO management fees) and manpower against the approved CDP and approved resources. Proactively initiates corrective action as needed.
• Responsible for the ongoing risk-benefit assessment of a compound until approval in a main country. Analyses incoming clinical data, relevant medical and scientific information and initiates actions or decisions as appropriate
.• In consultation with the Nucleus Head, Global Clinical Program Excellence Leader (GCPEL) and relevant Product Team (PT) members, is responsible for communication of medical project and study strategy, study results and clinical project results to internal and external bodies (e.g. regulatory authorities).
Prepares assessments and recommendations at Decision Points and presents them together with the GPL to the Development Management Committee.
• Responsible for defining the strategic approach and managing preparation of medical sections of key Regulatory documents (e.g. briefing document, submission package). Compiles and maintains Investigators’ Brochures (IB).• Provides medical expertise to Global Strategic Marketing (for marketed products) and Strategic New Product Marketing (for development projects) and defines together with Medical Affairs the publication strategy. Approves publications and ensures consistency of publications with clinical data and publication strategy. Contributes to Opinion Leader development and publications strategy with implementation detail. Establishes and maintains appropriate external scientific advisory boards and assists in advocacy development.• Provide medical assessment of in- and out-licensing opportunities of development projects, foster patient-centric trial designs, and consider patient involvement in clinical development and trial design planning• Approves domestic study concepts to ensure compliance with global strategy.
Biotech Expertise: Experience in pre-revenue biotech environments, particularly those who have successfully advanced drugs through registration.
• Regulatory Experience: Must have direct experience interacting with regulatory agencies and overseeing the process of bringing a drug to market.
• Cultural Adaptability: Candidates should be able to navigate the cultural differences between German and American working styles, ensuring seamless integration into the team.
• Strategic & Creative Thinking: Ideal candidates should be open-minded, innovative, and solutions-oriented, embracing the client's emphasis on out-of-the-box thinking and agility.
Benefits of Working in ICON:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a culture that rewards high performance and nurtures talent.
We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals- both ours and yours. We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans- and related benefits such as life assurance- so you and save and plan with confidence for the years ahead.
But beyond the competitive salaries and comprehensive benefits, you’ll benefit from an environment where you are encouraged to fulfill your sense of purpose and drive lasting change.
ICON is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sexual orientation, gender identity, national origin, disability, or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.
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