Clinical Science Specialist

MoonLake Immunotherapeutics; Cambridge; Hybrid; GBP 50,000 - 90,000; Full time

Job summary

A leading company in innovative therapeutic development seeks a Clinical Scientist Specialist to advance clinical studies and ensure compliance with regulatory standards. This role emphasizes collaboration with clinical teams and requires a postgraduate degree along with significant experience in the pharmaceutical/biotech sector. Enjoy flexible working arrangements and opportunities for career growth in a dynamic environment.

Benefits

Flexible work arrangements

Career growth opportunities

Qualifications

• Education in a science discipline essential.
• Experience in pharmaceutical/biotech industry preferred.
• Involvement in Phase II or III clinical trials is critical.

Responsibilities

• Provides support for clinical study designs and reviews.
• Acts as primary liaison for medical monitor inquiries.
• Leads process improvements and ensures regulatory compliance.

Skills

Communication

Data Interpretation

Project Management

Collaboration

Education

Postgraduate degree (MSc or PhD)

Job description

Job Purpose

The Clinical Scientist Specialist participates in the development of the clinical development strategy and plan, supporting various deliverables for effective and efficient execution of the plan for the assigned molecule(s)/indication(s).

Major Accountabilities

• Provides strategic clinical science support for assigned studies and programs, including development of clinical study designs.
• Conducts or oversees clinical review of study data, identifying and evaluating data trends, outliers, protocol violators, etc., and communicates relevant medical inquiries.
• Acts as the primary liaison for medical monitor inquiries from clinical operations, CROs, etc.
• Collaborates with clinical operations, Medical Directors, and other groups in developing clinical science documentation such as protocols, ICFs, CRFs, and Clinical Study Reports.
• Contributes to other documentation like protocol summaries, safety monitoring plans, investigator brochures, etc.
• Develops clinical presentation materials for internal/external meetings and communications.
• Participates in regulatory filings and responses to queries from internal and external parties.
• Supports communication strategies for studies, including KOL interactions and medical meetings.
• Maintains scientific and clinical knowledge in relevant therapeutic areas.
• Leads or participates in process improvements within teams.
• Ensures compliance with laws, regulations, SOPs, and guidelines.

Your Profile

Education: Postgraduate degree (MSc or PhD) in a science discipline.

Experience: Experience in the pharmaceutical/biotech industry, with relevant disease area experience preferred. Experience in drug development of large Phase II or III trials, including design and conduct.

Skills/Knowledge/Behavioral Competencies: Knowledge of GxP and regulatory standards, excellent communication skills, data interpretation and presentation skills, organizational ability, independence, collaboration skills, and project management capability.

Work Location

• 2 days a week in Cambridge or Porto offices.

Why us?

An exciting opportunity! MoonLake is a dynamic, innovative company seeking passionate individuals. We offer a learning environment, impactful work, flexible work arrangements, and career growth opportunities.

Our Core Values

• We do Stellar Science: Creating innovative therapies with high quality.
• We go beyond: Challenging norms boldly and positively disrupting our field.
• We unlock value: Creating long-term value for investors and communities.