Senior Clinical Scientist - Depression
TFS HealthScience
TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full-service capabilities, resourcing, and Functional Service (FSP) solutions.
We are seeking a Senior Clinical Scientist / Clinical Development Consultant to support an innovative biotechnology company advancing a novel programme in depression . This is a part time freelance assignment.
We are open to flexibility on the FTE split for the right profile.
Key responsibilities
Current phase:
Contribute to the scientific strategy for the drug development programme.
Design and develop clinical study protocols and synopses.
Provide scientific input to study design, endpoints and development planning.
The role is expected to expand to include:
Interpreting and analysing clinical study data together with statisticians and physicians.
Writing and reviewing clinical study documentation.
Collaborating with Medical Affairs, Regulatory Affairs, biometrics and external researchers.
Presenting study results internally and externally.
Ensuring studies meet scientific, regulatory and ethical requirements.
Qualifications
Advanced degree in Life Sciences, Pharmacy, Medicine, Neuroscience or a related discipline (PhD, PharmD, MD or equivalent preferred).
Hands on clinical development experience in depression is a requirement for this assignment. Broader psychiatry or CNS experience alone will not meet the client's need.
Demonstrated experience authoring clinical study protocols and synopses in a drug development setting.
Senior enough to contribute independently to clinical development strategy in a small biotech environment.
Based in or able to commute to Copenhagen.
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