- Are you passionate about clinical outcomes research and has interest in innovative new COA instruments and capturing technologies?
- We are looking for a research professional to join our Clinical Development Organization as COA Scientist - Specialist.
- With our COA scientific team we aim to incorporate physician, caregiver and patient perspectives into clinical research through the development and utilization of COAs and methods.
- The team is reporting to the Head of Clinical Development Business Support, and will support all business units in deriving broad understanding of relevant conditions and measuring relevant concepts of the conditions, in a scientifically robust manner using innovative COA instruments and technologies.
Your job and key responsibilities
- As COA specialist you will be developing, assessing, implementing, interpreting and disseminating COA instruments to derive treatment benefit during the clinical development of new molecules.
- You will support the clinical development programs, working closely with the Clinical Research Scientist within Neuroscience, with advice on selection and use of suitable COAs.
- You will bring insight on psychometric assessment of the measurement properties, reliability, validity and sensitivity that can be applied also in development of new COAs. You will facilitate selection and implementation of capturing modality of COA measures .
Other responsibilities includes
- Maintain expertise up to date – following the field, regulatory requirements and developments
- Provide advice and support to Study Teams on COA activities (sourcing, translations, rater selection, training and certification, COA monitoring, rater surveillance)
- Participate in oversight of sourced COA monitoring and rater surveillance activities
- Efficient processes and training relevant to COA activities in clinical studies
- Maintain knowledge on COAs across projects incl. ensure up to date COA library
- The position offers an exciting job, with a great opportunity for further developing and advocating the role in the organization, and for mentoring of more junior staff.
- You will be part of a smaller dedicated, passionate, and dynamic department, focused on optimizing knowledge, learning, processes and outcome assessments as an integral part of the global clinical activities.
- In the position you will engage with internal and external stakeholders, including Therapeutic Areas within Psychiatry and Neurology, Bio statisticians, Regulatory teams, Medical Affairs, External Regulatory Bodies and COA vendors.
Our preferred candidate has the following personal and professional qualifications:
- Doctorate or Master’s Degree in Clinical Psychology, Neuropsychology, Psychometrics, Medicine/ Technology or other relevant scientific background
- Training in COA methodology and experience with COA regulations
- At least 3-5 years’ experience within clinical outcomes research, preferable with experience in clinical development, neuroscience and regulatory interactions
- Insight to or experience with electronic capturing of outcomes (incl. wearables/apps or other technologies)
- High performing individual, self-motivating and able to work independently and as part of a team
- Communicates effectively, being comfortable presenting to small and large audiences
- Detail-oriented when required and with strong analytical skills
- Positive mindset and strives to find innovative solutions
- Fluency in English (oral and written)
- Our company is a global pharmaceutical company specialized in psychiatric and neurological disorders.
- For more than 70 years, we have been at the forefront of research within neuroscience.
- Our key areas of focus are depression, schizophrenia, Parkinson's disease and Alzheimer's disease.
- An estimated 700 million people worldwide are living with psychiatric and neurological disorders and far too many suffer due to inadequate treatment, discrimination, a reduced number of working days, early retirement and other unnecessary consequences.
- Every day, we strive for improved treatment and a better life for people living with psychiatric and neurological disorders – we call this Progress in Mind.
- Our approximately 5,300 employees in 55 countries are engaged in the entire value chain throughout research, development, production, marketing and sales.
- Our pipeline consists of several late-stage development programmes and our products are available in more than 100 countries.