Senior Clinical Scientist - Depression

TFS HealthScience; København; On-site; DKK 700,000 - 950,000; Part time

Job summary

TFS HealthScience is seeking a Senior Clinical Scientist / Clinical Development Consultant to support a biotech programme advancing a novel depression therapy. This is a part-time freelance assignment based in or commuting to Copenhagen.

You will contribute to scientific strategy, design and develop protocols, and provide input on endpoints, development planning and regulatory alignment. The role expands to include data interpretation, study documentation, collaboration across Medical Affairs

Qualifications

• Advanced degree in Life Sciences, Pharmacy, Medicine, Neuroscience or related discipline; PhD/MD/PharmD preferred.
• Hands-on clinical development experience in depression is required for this assignment.
• Experience authoring clinical study protocols and synopses in a drug development setting.
• Ability to contribute independently to clinical development strategy in a small biotech environment.

Responsibilities

• 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.
• Interpreting and analysing clinical study data 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.

Skills

Clinical development

Study design

Data interpretation

Regulatory awareness

Education

PhD/MD/PharmD preferred

Advanced life sciences degree

Job description

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.