Senior Principal, Patient Centered Outcomes

4 weeks ago

Darwin, Australia Pharmiweb Full time
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.

Senior Principal, Patient Centred Outcomes

ICON Patient Centred Outcomes (PCO) is part of ICON plc, a leading global Clinical Research Organization headquartered in Dublin, Ireland. Our PCO group undertakes consultancy projects for international clients in both the pharmaceutical and medical device sectors, supporting development of medicines and clinical trials.

The work of the PCO group focuses on patient-centred research, including health related quality of life, disease signs and symptoms, treatment preference, adherence and satisfaction. The group is respected globally for the quality and innovation of their applied qualitative and quantitative work. Much of their work involves Clinical Outcome Assessment (COA) measurement development and validation including conducting patient interviews and focus groups, qualitative analysis, and psychometric evaluation.

Our PCO team is primarily based in UK, US (East Coast and West Coast), Canada, and France (Lyon), as well as having staff in other countries in Europe and the Americas.

The candidate will be required to support the PCO practice lead, in taking senior managerial responsibility for the department. In addition, the candidate recruited for this role will be expected to utilise their skills in outcomes research and related work to contribute to all aspects of the department's work as well as supporting the development of the team globally.

Key Responsibilities
  • Act as a scientific thought partner with the client and the project team throughout the project
  • Identify and apply leading edge tools/techniques and develops new and insightful analytic approaches.
  • Develop endpoint reviews that include consolidating evidence, identifying gaps, and proposals on how to address gaps
  • Critically evaluate COA instruments to identify gaps and strategies to address gaps.
  • Review and finalize project deliverables and ensure study findings are valid and reliable and presented in a manner that is up to a high standard.
  • Lead regulatory EMA/FDA dossier development.
  • Independently develop project plans and scientific content in proposals and achieves good conversion rate of submitted and won proposals.
  • Serve as KOL on project methodology, project risk and project execution.
  • Develop a comprehensive set of sound recommendations on scientific methods and approaches that help clients meet their goals as well as identify those that will not help clients meet their goals. Prioritizes recommendations based on ease of implementation and expected impact.
  • Lead interactions with clients in the pharma/biotech/medical device industries
  • Initiate and nurture client relationships and maintains contacts to build reputation and deal flow.
  • Contribute to shaping business strategy and new product/service development.
  • Regularly pursue new business opportunities and leads the organization to meet changing client needs, responsible for teams’ alignment and support of BD efforts
  • Represent COA at internal and external meetings and strategy review presentations/overviews.
  • Regularly contribute to external efforts such as International Society of Quality-of-Life Research (ISOQOL), International Society of Pharmacoeconomics & Outcomes Research (ISPOR), CPATH, DIA, FDA initiatives, National Institute of Health (NIH) initiatives etc.
Experience Requirements:
  • Master’s degree in outcomes research or related discipline, PhD strongly preferred.
  • Significant proven industry experience in a similar role. Extensive academic research experience in a related methodology may offset some of this work experience.
  • Direct experience leading a diverse set of bespoke outcomes research studies in collaboration with pharma / biotech / medical device study teams or CRO Clinical Operations divisions.
  • Demonstrated experience in consulting.
  • Demonstrated advanced scientific leadership experience and directing project teams.
  • Assesses whether instruments are fit-for-purpose with particular attention to content validity and psychometric properties specific to context of use.
Skill Requirements:
  • Able to efficiently direct teams on data gathering effort
  • Able to lead team in formulating, articulating and prioritizing key conclusions
  • Demonstrated ability to work well within diverse project teams
  • Excellent communication and scientific writing skills, as demonstrated by peer-reviewed publications, technical reports, or other scholarly work
  • Articulate and persuasive. Draws information well from others
  • Strong analytical and problem-solving skills
  • Proficient in methodology around ePRO and translations
  • Ability to manage or direct large portfolio of projects in terms of dollar volume and number of projects
  • Demonstrated ability to analyze project risks, define mitigation actions of identified risks, and apply lessons learned across projects and during the proposal development stage.
  • Able to successfully communicate with and advise clients
Knowledge Requirements
  • In depth knowledge of regulatory and scientific guidance including FDA & EMA guidance’s, FDA qualification documentation, ISPOR Task Force papers, etc.
  • Extensive knowledge of practical research implementation
  • Comprehensive understanding of health outcomes research principles and familiarity with key aspects of the literature
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.

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.

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