COA (Clinical Outcome Assessment) Lead

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.

As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.

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

Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• Competitive base salary and performance related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

Benefits may vary depending on role and location.

Visit our careers site to read more about the benefits ICON offers.

Inclusion and Accessibility

ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.

If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.

Are you a current ICON Employee? Please click here to apply

Global contract research organization providing outsourced clinical development services. Headquartered in Dublin, Ireland.

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