Senior Principal /Director, Patient Reported Outcomes COA job in

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Senior Principal/ Director, Patient Reported Outcomes/ COA

Location: Flexible London or Abingdon

ICON PLC is a Clinical Research Organization with a strong global reputation in our approach to clinical development. We apply scientific and operational excellence across all phases of clinical trial outsourcing services for our clients. We have offices in 40 countries with over 80 offices worldwide and over 12K employees globally and an annual turnover in excess of $1.2 billion.

ICON’s Clinical Outcome Assessment (COA) group provides services geared to meet the demands of global and national markets for high quality patient-centered data. Our COA group brings together a large team of Outcomes Research scientists and consultants with expertise in the selection, development, validation and analysis of Patient Reported Outcome (PRO) and other COA instruments. The group has a deep understanding of the marketplace and regulatory landscapes, and helps decision-makers to understand the value of patient endpoints and to estimate the impact of new health technologies.

In this role, you will serve as the project director or scientific advisor for COA projects, taking responsibility for the scientific integrity of the research and support the overall COA business strategy.

Acts as scientific thought partner with the client and the project team throughout the project
Identifies and applies leading edge tools/techniques and develops new and insightful analytic approaches
Develops endpoint reviews that include consolidating evidence, identifying gaps, and proposals on how to address gaps
Critically evaluates COA instruments to identify gaps and strategies to address gaps
Reviews and finalizes project deliverables and ensures study findings are valid and reliable and presented in a manner that is up to a high standard
Leads regulatory EMA/FDA dossier development
Independently develops project plans and scientific content in proposals and achieves good conversion rate of submitted and won proposals
Serves as KOL on project methodology, project risk and project execution
Develops 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
Leads interactions with clients in the pharma/biotech/medical device industries
Initiates and nurtures client relationships and maintains contacts to build reputation and deal flow
Contributes to shaping business strategy and new product/service development
Regularly pursues new business opportunities and leads the organization to meet changing client needs; responsible for teams’ alignment and support of BD efforts
Represents COA at internal and external meetings and strategy review presentations/overviews
Regularly contributes 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

We offer a strong benefits package that includes comprehensive health and pension plans, competitive salary, holidays, and an incentive plan for strong performers. Additionally, we have cutting edge technology to ensure better outcomes.

If you are looking to join a company which will offer you a strong support network with an inspiring and motivating working environment, this is the job for you.

ICON is an equal opportunity employer and committed to providing a workplace free of any discrimination or harassment.

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Senior Principal /Director, Patient Reported Outcomes COA

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