Research Scientist – Patient-Centered Outcomes & In-Trial Research

Description

The team is the in-trial research team inside the Patient-Centered Research group, which combines health sciences, psychometrics, epidemiology, psychology and other social sciences. The group runs quantitative and qualitative studies, including clinical outcomes assessment development, patient preference and utility work, implementation science, Delphi panels and secondary data analysis with advanced statistics.

The in-trial research team runs qualitative interview studies and surveys inside clinical trials to gather feedback from participants, caregivers, investigators and study staff. Topics include patients' experience of their condition and its effect on their lives, treatment benefit, trial participant experience and the burden of taking part. This work can use an embedded design, where it is part of the trial protocol and consent form, or an associated design, where it runs under its own protocol, consent form, ethics approval, and separate site recruitment and contracting. It can happen in any trial phase and at screening, mid-trial or exit. Regulators have shown growing interest in this work to support the meaning of trial outcomes, meaningful change and meaningful treatment benefit.

This is a research scientist role on the team, working in the office. The role is the independent principal investigator on projects, owning delivery and scientific quality while delegating project management to more junior staff. You will oversee and take part in a large project portfolio, bring new scientific approaches, and carry significant responsibility for sales targets and client development.

Responsibilities

• Apply deep knowledge of scientific methods, mostly qualitative and some quantitative.
• Lead the science on your projects and give scientific direction to team members.
• Produce high-quality deliverables and advise on the best methods and innovations in project plans and design.
• Publish in peer-reviewed journals and present at professional meetings.
• Carry a high volume of projects, whether you run them, join them or consult on them.
• Keep up with regulatory requirements and guidelines.
• Deliver studies and results directly to clients, help colleagues refine study design when you have specialist expertise, and take part in non-project work such as publications, workshops, advisory boards and FDA meetings.
• Build and maintain client relationships and understand the structure of the pharmaceutical industry and the FDA.
• Recommend the methods that will and will not help a client reach their goals, and provide rigorous deliverables that meet their objectives.
• Help clients prepare for regulatory meetings, and attend them with clients when asked.
• Bring in proposal leads, write proposals, manage the proposal process and close sales.
• Reach an annual utilization target of 60%, unless a different target is set.
• Keep internal timelines aligned with client deadlines and keep project hours and budget within the contracted amount.
• Manage scope creep, out-of-scope work and legal or contracting issues.
• Develop and present internal scientific training, follow SOPs and company requirements, and support new product development and scientific innovation.

Requirements

• A doctorate in a life sciences or social sciences field such as psychology, epidemiology, health services or public health, with more than 3 years of experience in a relevant area.
• Or a master's degree in a similar field, with more than 5-7 years of experience in a relevant area.
• Equivalent combinations of education, training and directly related experience may be considered.
• Experience with qualitative analysis software such as Atlas.ti, NVivo, MAXQDA or Dedoose.
• Experience analyzing patient experience data, such as interviews, surveys or clinical outcome assessments.
• Experience managing several projects at once.
• Preferred: experience in pharma or consulting companies.
• Preferred: familiarity with working in a clinical research environment.
• Deep understanding of qualitative research principles and how they apply in clinical trials, plus broad knowledge of qualitative methods.
• Advanced understanding of the operational and logistical challenges of in-trial research.
• Strong written and verbal communication, including scientific writing.
• Strong analytical and problem-solving skills.
• Ability to manage, oversee or lead project tasks independently and delegate them well to the team.
• Ability to manage client relationships.
• A collaborative team member who can juggle several tasks efficiently.

Conditions

Standard Monday to Friday schedule.

Office-based work.

Equal opportunity applies to all candidates.

Benefits

• You join a global company where collaboration and development are part of daily work, and your contributions have visible impact.