Clinical Science Specialist

Job title:

Clinical Science Specialist

Company

MoonLake Immunotherapeutics

Job description

Job PurposeThe Clinical Scientist Specialist participates in development of the clinical development strategy and plan and supports 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 others in conducting clinical review of study data, identifying and evaluating study data trends, outliers, protocol violators, etc. and working with others to develop and communicate relevant medical inquiries.
• Where assigned, acts as the primary liaison/point-of-contact from the team for medical monitor inquiries from clinical operations, clinical research organizations (CROs), etc.
• Collaborates with clinical operations, Medical Directors, and other groups etc. in the development of clinical science documentation, including the protocol (e.g., eligibility, safety, protocol updates etc.), Informed Consent Form (ICF), Case Report Forms (CRFs), Clinical Study Reports, etc.
• Provides input into other documentation managed by other MoonLake groups as required (e.g., protocol summaries, safety monitoring plans, process documents, investigator brochures, safety-related documentation etc.).
• Leads and/or collaborates in the development of clinical presentation slides and other materials for internal/external meetings and/or ongoing communications (e.g., Investigator and Steering Committee meetings, study coordinator or clinical research administrator training, study newsletters, communications to study sites, etc.).
• Plays a role in completion and submission of regulatory filings and other regulatory documentation, including responses to questions from other internal and external parties regarding assigned studies and programs.
• Plays a role in the development and implementation of communications strategies to support existing and concluded studies. Includes Key Opinion Leader (KOL) interactions, major medical meetings, congresses and other events, publications and other materials.
• Maintains scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment. Including internal and external developments, relevant to clinical development that can have internal/external influences and/or implications for the assigned therapeutic and disease area(s).
• As appropriate, leads/participates in ongoing enhancements/development of core and sub-team processes, structures, systems, tools and other resources.
• Consistently complies with all governing laws, regulations, MoonLake Standard Operating Procedures (SOPs) and other guidelines.

Your profileEducation:

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

Experience:

• Experience in the pharmaceutical and/or Biotech industry, experience in the relevant disease areas would be an advantage.
• Experience working in drug development of large Phase II or Phase III clinical trials.
• Experience in designing and conducting large Phase II or Phase III clinical trials

Skills/knowledge/behavioural competencies:

• Robust working knowledge of GxP and related regulatory standards relating to drug development and promotional activities.
• Excellent oral and written skills.
• Ability to interpret, process and present information/data in innovative ways to meet the needs of multiple stakeholders.
• Highly organized, able to priorities work, work well under pressure and meet deadlines.
• Independent, self-starter with a proactive, problem-solving approach.
• Ability to work with and influence others in a flexible, collaborative style with internal and external teams (including CROs and Consultants).
• Ability to see complex projects to completion, and to work on a broad range of tasks within a project.

Work Location:

• 2 days a week in our brand new Cambridge or Porto Office(s)

Why us?An exciting job opportunity awaits you!MoonLake is a dynamic and innovative company pushing the boundaries of possibility, and we are looking for passionate individuals to join our stellar team.What we offer:Learning Environment: An opportunity to learn and grow alongside experienced professionals in a supportive and innovative biotech environment.Impactful Work: Contribute to ground-breaking projects that have the potential to transform global healthcare.Flexibility and Balance: Work remotely/hybrid, enjoying a healthy work-life balance while making meaningful contributions to our team.Career Growth: A clear path for career progression, with the chance to take on more responsibilities as you develop your skills.Our Core ValuesWe look for potential MoonLakers that embody our three core values that drive our pursuit of excellence:We do Stellar Science: We aspire to create novel therapies that elevate treatment horizons, with innovative science, and high quality, always.We go beyond: We aspire to be positively disruptive in our field, and bold in the way we challenge the norms and each other.We unlock value: We aspire to create long-term value for investors and communities.About usMoonLake Immunotherapeutics is a clinical-stage biopharmaceutical company unlocking the potential of sonelokimab, a novel investigational Nanobody® for the treatment of the inflammatory disease, to revolutionize outcomes for patients.We continue to make significant progress in our Global Clinical Development Programs. The company’s focus is on inflammatory diseases with a major unmet need, including hidradenitis suppurativa and psoriatic arthritis – conditions affecting millions of people worldwide with a large need for improved treatment options. MoonLake was founded in 2021 and is headquarted in Zug, with hubs in Cambridge & Porto.Further information is available at

Expected salary

Location

Cambridge

Job date

Sat, 14 Jun 2025 22:50:01 GMT

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