COA (Clinical Outcome Assessment) Lead

ICON plc

11d • Remote

About The Position

Principal Clinical Data Scientist Lead (COA Lead) - Spain/Poland/Ireland/UK/US - Home or office based 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 The COA Lead is accountable for the definition of COA endpoint strategies and responsible for the conduct of related activities in relation to specific programs, assets or indications. The scope evolves as the COA Lead gains experience in role and demonstrates ability to take more in quantity (TA portfolio), impact (primary and key secondary endpoints) and exposure (strategic assets or indications). Responsibilities Contribute to the Target Value Proposition with respect to patient-centric outcomes value messaging Contribute to a successful strategy for innovative product by an optimized COA endpoint strategy aligned with Sponsor’s Best In Class / First In Class approach Generate a comprehensive understanding of a disease and treatment paradigm through primary and secondary research Advise on the use and/or development of Fit-for-Purpose COA instruments in clinical research projects; including gap analyses, implementation, statistical analyses, psychometric validation and dissemination Ensure proper input into medical evidence generation plans, and effective implementation related to COAs throughout execution Manage the qualitative and quantitative research projects to close the validation gap(s) on the selected COA instruments (including vendor management) Prepare the scientific documents (reports, regulatory documents, publications,...) for internal and external communication Manage vendors as needed (from Request For Proposal to reception of deliverables, including project management and budget control). Specific role activities for a COA Lead also include advanced activities: Leads specific internal organizational initiatives, within COA and PID-HVT (eg. RACI, templates, guidance) Advocate for the role of quantitative and qualitative COA across Sponsor, participate in creating and delivering education on COAs for internal business partners Identify, track and participate in global external collaborations regarding policy, standards and use of COAs e.g. Critical Path PRO Consortium, ISPOR and DIA Working Groups, IMI… Mentor more junior COA scientists, share specific knowledge and expertise with the COA team. Provide direction and delegate specific tasks to associate COA scientist Implement new methodologies and promote innovative approaches. Define or update overarching approach and framework to COA endpoints strategies in strategic area (eg Oncology, I&I, rare diseases) Experience needed Relevant experience in COA in Pharma/CRO/Consultancy : ideally proven track record from scientific publications in core COA disciplines such COA data analyses and/or creation or validation of new COAs and/or COA endpoint strategy implementation Knowledge of the drug development process and the regulatory (FDA, EMA, local agencies) and payer (EUnetHTA, NICE, HAS, G-BA, other local agencies) environment Qualification Relevant advanced academic degree (e.g. doctorate or masters in psychology, anthropology, sociology, public health, epidemiology, psychometrics, clinical research, physiotherapy, pharmacy, medicine, biostatistics…) Training in COA methods Soft and technical skills : Strong analytical and synthesis skills of qualitative and quantitative data Accountability and hands-on mindset, autonomy and sense of initiative Scientific rigor, Attention to detail, Analytical Thinking Good interpersonal and communication skills, both written and oral Ability to manage multiple priorities and projects, and balance workload and timelines Appetite for innovation and change management Ability to interact and manage external and internal networks 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, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised 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, subsidised travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON 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 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 ICON is an award-winning workplace that enables you to make a difference to patients’ lives by being part of a world-class clinical research organisation that helps deliver new medicines & medical devices that are benefitting patients worldwide. You are also part of a diverse company that cares about our world and is dedicated to conducting business more sustainably and supporting the communities in which we live. If you’re as driven as we are, join us. You’ll be working in a great environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry. Didn’t find the role you were looking for? Even if the perfect role isn’t available right now, we’re always excited to connect with talented individuals. Register to our Talent Community to receive updates on roles that align with your career goals.

Requirements

• Relevant experience in COA in Pharma/CRO/Consultancy : ideally proven track record from scientific publications in core COA disciplines such COA data analyses and/or creation or validation of new COAs and/or COA endpoint strategy implementation
• Knowledge of the drug development process and the regulatory (FDA, EMA, local agencies) and payer (EUnetHTA, NICE, HAS, G-BA, other local agencies) environment
• Relevant advanced academic degree (e.g. doctorate or masters in psychology, anthropology, sociology, public health, epidemiology, psychometrics, clinical research, physiotherapy, pharmacy, medicine, biostatistics…)
• Training in COA methods
• Strong analytical and synthesis skills of qualitative and quantitative data
• Accountability and hands-on mindset, autonomy and sense of initiative
• Scientific rigor, Attention to detail, Analytical Thinking
• Good interpersonal and communication skills, both written and oral
• Ability to manage multiple priorities and projects, and balance workload and timelines
• Appetite for innovation and change management
• Ability to interact and manage external and internal networks

Responsibilities

• Contribute to the Target Value Proposition with respect to patient-centric outcomes value messaging
• Contribute to a successful strategy for innovative product by an optimized COA endpoint strategy aligned with Sponsor’s Best In Class / First In Class approach
• Generate a comprehensive understanding of a disease and treatment paradigm through primary and secondary research
• Advise on the use and/or development of Fit-for-Purpose COA instruments in clinical research projects; including gap analyses, implementation, statistical analyses, psychometric validation and dissemination
• Ensure proper input into medical evidence generation plans, and effective implementation related to COAs throughout execution
• Manage the qualitative and quantitative research projects to close the validation gap(s) on the selected COA instruments (including vendor management)
• Prepare the scientific documents (reports, regulatory documents, publications,...) for internal and external communication
• Manage vendors as needed (from Request For Proposal to reception of deliverables, including project management and budget control)
• Leads specific internal organizational initiatives, within COA and PID-HVT (eg. RACI, templates, guidance)
• Advocate for the role of quantitative and qualitative COA across Sponsor, participate in creating and delivering education on COAs for internal business partners
• Identify, track and participate in global external collaborations regarding policy, standards and use of COAs e.g. Critical Path PRO Consortium, ISPOR and DIA Working Groups, IMI…
• Mentor more junior COA scientists, share specific knowledge and expertise with the COA team.
• Provide direction and delegate specific tasks to associate COA scientist
• Implement new methodologies and promote innovative approaches.
• Define or update overarching approach and framework to COA endpoints strategies in strategic area (eg Oncology, I&I, rare diseases)

Benefits

• 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, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised 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, subsidised travel passes, health assessments, among others.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees