Senior Director, Study Start Up - Blue Bell, PA - remote
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
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 organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation 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.
The Senior Director, Study Start-Up, is responsible for developing and implementing an effective structure, strategies, business/department objectives, and processes to ensure accelerated site activation timelines in their region or customer, and with highest quality. This involves monitoring and improving key performance metrics around reduced cycle times, predictability of delivery, and enhanced productivity, and will comprise oversight over key customer, operational and financial activities.
In addition to providing strategic and operational leadership to the group, the Senior Director, Study Start-Up will be knowledge in local regulations, act as a senior counterpart to internal and external customers, and ensure growth of their customer and/or region.
As a Senior Director, expected to recognize the importance of and create a culture of continuous improvement with a focus on quality, streamlining our processes, adding value to our business and meeting internal and external client needs.
Evaluate changes in the competitive market as well as regulatory environment to ensure ICON is at the forefront of knowledge and advances, and is providing best in class site activation services.
Act as a change agent within and beyond the department to align with corporate and strategic goals of, and beyond, the department
• Lead customer(s) and/or regional delivery of accelerated site and study start-up with highest quality standards to exceed customer expectations. This involves monitoring and improving key performance metrics around reduced cycle times, predictability of delivery, and enhanced productivity, and will comprise oversight over key activities such as regulatory approval, critical document package (CDP) collection, EC/IRB submission/approvals, ICF development, budget and contract negotiations, and IP release. Customer oversight includes attendance of key customer internal and external meetings as outlined in any contractual or communication plan. It also includes knowledge of MSAs and Client SSU processes, procedures and systems.
• Accountable for predictability and productivity within each assigned portfolio and/or country.
Drive system compliance
Use of data analytics to assess metrics trending and proactively mitigate concerning trends
• *Accountable for appropriate resourcing and corresponding utilization, including appropriate forecasting and headcount control, to ensure staffing levels are at all times conducive to operational and financial success. This includes decisions in the hiring process whilst keeping business need and profitability in mind.
• Identify and subsequently drive process improvement, efficiencies and technological development to enable the group to deliver to year on year targets.
• Drive continuous Engagement and Enablement of team to perform to their full potential by providing them with the required tools and guidance.
• *Ensure that budget parameters are adhered to, and spending controlled, resulting in financial health of projects, portfolios and/or department.
Review budgets for the purpose of proposals and sales when and as required. • *Ensure quality by pro-actively assessing compliance and implementing measurable solutions and preventive actions. Communicate on all applicable quality issues to keep Executives and representatives informed of all critical issues.
• Act as customer/portfolio or country level client liaison and escalation point of contact; resolve customer relationship issues. • Facilitate increased productivity whilst maintaining quality levels.
• Represent Start Up at audits and inspections. Represent the department or region on committees and work groups to support the development and implementation of new initiatives and strategic direction of the department
• *Work closely with teams on Business Development opportunities to support the growth of the assigned portfolio and/or country(ies) and provide regional/client based knowledge to achieve success. • *Develop key relationships with the wider business at regional/global level.
• Lead key initiatives, or collaborate on global initiatives, across the Start Up group. Ensure best practice and continuity in the ICON services.
Contribute to business continuity plans if requested.
• Travel (approximately 20% depending on country structure and direct report levels) domestic and/or international
• Responsible for performing activities that are in compliance with applicable corporate and departmental policies, standard operating procedures and operating guidelines and performing another duties as assigned by the management.
• Facilitate increased productivity whilst maintaining quality levels.
• Represent Start Up at audits and inspections.
Represent the department or region on committees and work groups to support the development and implementation of new initiatives and strategic direction of the department
• *Work closely with teams on Business Development opportunities to support the growth of the assigned portfolio and/or country(ies) and provide regional/client based knowledge to achieve success.
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 can 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 fulfil 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, sex, 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.
What ICON can offer you:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family’s needs.
- Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
- Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.
Visit our careers site to read more about the benefits ICON offers.
ICON, including subsidiaries, 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, colour, religion, sex, 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 or submit a request here
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.
Are you a current ICON Employee? Please click here to apply
