Senior Clinical Scientist

TFS HealthScience; Malmö kommun; Presencial; SEK 900 000 - 1 200 000; Tempo integral

Resumo da oferta

TFS HealthScience is seeking a Senior Clinical Scientist / Clinical Development Consultant to support a biotechnology partner advancing a clinical programme in Major Depressive Disorder.

You will lead the development of study synopses and protocols, shape development strategy, and collaborate with Clinical Operations, Biometrics, Regulatory Affairs, and senior stakeholders to ensure scientifically robust and regulatorily compliant studies.

Qualificações

• Advanced degree in Medicine, Neuroscience, Pharmacy, Life Sciences or related discipline.
• Extensive hands-on experience in clinical development within depression.
• 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.

Responsabilidades

• 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.

Conhecimentos

Study design

Endpoint selection

Stakeholder management

Communication skills

Clinical development

MDD experience

Formação académica

Advanced degree in Medicine, Neuroscience, Pharmacy, Life Sciences

Descrição da oferta de emprego

About This Role

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.

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 clinical development programme within Major Depressive Disorder (MDD).

Key Responsibilities

• 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.

Future Responsibilities

• 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.

Qualifications

• 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.