Senior Principal, Patient Centered Outcomes

4 weeks ago

Reading, United Kingdom ICON Full time
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.
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.
The candidate will be required to support the PCO practice lead, in taking senior managerial responsibility for the department. Act as a scientific thought partner with the client and the project team throughout the project
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
Regularly pursue new business opportunities and leads the organization to meet changing client needs, responsible for teams’ alignment and support of BD efforts
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.
Master’s degree in outcomes research or related discipline, PhD strongly preferred.
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 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.
Able to efficiently direct teams on data gathering effort
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
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.
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
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.
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. 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.
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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