Senior Clinical Scientist, MDD Development & Strategy

TFS HealthScience; København; Vor Ort; DKK 900.000 - 1.300.000; Vollzeit

Zusammenfassung

TFS HealthScience is seeking a Senior Clinical Scientist / Clinical Development Consultant in Copenhagen to support a clinical development programme for Major Depressive Disorder. You will lead study synopsis and protocol development, shape strategy, and work closely with Operations, Biometrics, Regulatory, and senior stakeholders.

You will interpret data with statisticians and physicians, prepare study reports, and ensure compliance with scientific, regulatory, and ethical standards in a small

Qualifikationen

• Advanced degree in Medicine, Neuroscience, Pharmacy, Life Sciences, or a related discipline.
• Extensive hands-on experience in clinical development within depression.
• Demonstrated experience authoring clinical study synopses and full study protocols.
• Strong understanding of study design and endpoint selection in MDD studies.
• Experience supporting Phase I, Phase Ib, or Phase II clinical development programmes.
• Ability to work independently and contribute strategically within a small biotech environment.
• Excellent communication and stakeholder management skills.

Aufgaben

• Lead the development of clinical study synopses and full study protocols for upcoming MDD studies.
• Contribute to clinical development strategy and overall programme planning.
• Define study objectives, endpoints, eligibility criteria, and key design elements.
• Collaborate with Clinical Operations, Biometrics, Regulatory Affairs, and senior stakeholders.
• Provide scientific expertise to support development decisions and program advancement.
• Interpret and analyse clinical study data together with statisticians and physicians.
• Support the preparation and review of clinical study reports and related documentation.
• Present scientific findings internally and externally.
• Ensure studies meet scientific, regulatory, and ethical requirements.

Jobbeschreibung

TFS HealthScience is seeking a Senior Clinical Scientist / Clinical Development Consultant in Copenhagen to support a clinical development programme for Major Depressive Disorder. You will lead study synopsis and protocol development, shape strategy, and work closely with Operations, Biometrics, Regulatory, and senior stakeholders.

You will interpret data with statisticians and physicians, prepare study reports, and ensure compliance with scientific, regulatory, and ethical standards in a small