Director - Clinical Outcome Assessments

We are seeking a London, Hybrid or UK remote Director of Clinical Outcome Assessments, reporting to the Practice Lead, to serve as a senior member of our COA team by providing high-level technical expertise, strategic leadership and creativity to billable client engagements, business development efforts and internal initiatives.

The role holder will provide strategic input and advice to clients, lead a team of COA analysts, and develop robust and valuable conclusions and recommendations. They are vital to ensuring that we provide our clients with the insights and information they need to achieve success.

This role is focused in a high-growth area of the consulting business; the Clinical Outcome Assessment (COA) team. You will be expected to:

• Provide high level, technical expertise and strategic input and advice to clients.
• Lead a team of COA analysts, providing technical domain training and guidance in US and EU regulatory guidance for PRO/COA endpoints, qualitative, quantitative and mixed methods research and analysis within a COA context, literature and instrument reviews, clinical trial endpoint reviews, and development and validation of PRO endpoints for product labelling claims and to facilitate market access.
• Contribute significantly to the attainment of yearly revenue/profit targets, business development and proposal writing.

About You – experience, education, skills, and accomplishments

• A Master’s degree in health psychology, psychology, sociology, life sciences or other relevant topic, or a Bachelor’s degree .
• +10 years’ experience in Patient Reported Outcomes/Clinical Outcomes Assessment
• In-depth knowledge and experience of clinical outcomes assessments, patient reported outcomes, development and validation of outcome measures, and clinical trial endpoint strategy
• In-depth knowledge and experience of the pharmaceutical industry and the client’s operating environment (regulatory and HTA)
• Significant consulting experience in a client facing role, and the ability to instill confidence and convey authority with colleagues and clients
• Ability to lead multiple complex projects and project teams consecutively

It would be great if you also have:

• Experience of line management and training
• Experience of financial management
• Demonstrated business development experience
• Demonstrated thought leadership experience

What will you be doing in this role?

• Provide strategic advice to clients, in the context of their regulatory and commercial environment, identifying key issues and opportunities and recommending courses of action
• Lead strategic direction and take overall responsibility for the delivery and quality of multiple projects at once, proactively removing barriers to delivery
• Identify and develop new business opportunities with new and existing clients, prepare proposals, present at pitches and meet agreed sales targets
• Build a strong external profile in the COA community by attending conferences, driving thought leadership initiatives and representing Insira
• Line manage and develop direct reports, including appraisals, career progression plans and personnel issues
• Develop and deliver internal COA training (e.g. instrument reviews, research methods, regulatory and HTA guidance) and identify training needs for self and team
• Manage project financials, including profitability, invoicing, scope, time recording and monthly income forecasts

About the Team

Our team consists of 30+ outcomes researchers who have extensive methodological and commercial experience. We are experienced in the design, validation, and implementation of PRO measures and other COA instruments for clinical trials and clinical practice, with a focus on FDA, EMA, and HTA bodies. We have significant experience across a range of therapy areas, such as rare disease, oncology, immune disorders, respiratory, psychiatry, CNS, autoimmune, infectious diseases, pain, and women's health. Supported by a global multi-disciplinary team from the wider Insira team, we can involve medical writers, health economists, systematic reviewers, and strategic advisors in our projects as needed. Together, our experts provide integrated health economics and outcomes research (HEOR) and market access solutions across the product life cycle.

Hours of Work

This is a full-time permanent position (Remote UK or London Hybrid)

This position requires weekday (Monday - Friday) attendance with some scheduling flexibility available around core working hours.

Our UK Employee Benefits include:

• Private Medical Insurance or Health Cash plan
• Generous Pension Plan contribution rates
• Income protection insurance
• Life insurance
• Emergency Childcare or Adult care cover
• Eyecare vouchers
• From 25 Days Annual Leave + 8 Bank Holidays (option to buy and sell Annual leave)