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.