The Clinical Scientist Specialist participates in developing the clinical development strategy and supports various deliverables for the effective and efficient execution of plans for assigned molecules/indications.
Major Accountabilities
* Provides strategic clinical science support for assigned studies and programs, including the development of clinical study designs.
* Conducts or oversees clinical reviews of study data, identifying and evaluating data trends, outliers, protocol violations, and working with others to develop and communicate relevant medical inquiries.
* Acts as the primary liaison for medical monitor inquiries from clinical operations, CROs, etc., where assigned.
* Collaborates in developing clinical documentation such as protocols, ICFs, CRFs, and Clinical Study Reports with clinical operations, Medical Directors, and other groups.
* Contributes to other documentation like protocol summaries, safety monitoring plans, investigator brochures, and safety-related documentation.
* Leads or collaborates on developing presentation materials for meetings and communications, including investigator and steering committee meetings, training sessions, newsletters, and site communications.
* Supports the completion and submission of regulatory filings and responds to questions from internal and external parties regarding studies and programs.
* Participates in developing and implementing communication strategies for studies, including KOL interactions, medical meetings, congresses, publications, and related materials.
* Maintains current scientific and clinical knowledge in relevant therapeutic and disease areas, considering internal and external developments.
* Leads or participates in enhancing core and sub-team processes, structures, systems, tools, and resources.
* 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 or biotech industry, with relevant disease area knowledge preferred. Experience in large Phase II or III clinical trials and drug development is essential.
Skills/Knowledge/Behavioral Competencies:
* Strong knowledge of GxP and related regulatory standards.
* Excellent oral and written communication skills.
* Ability to interpret and present complex data innovatively.
* Highly organized, with the ability to prioritize, work under pressure, and meet deadlines.
* Proactive, independent, and problem-solving mindset.
* Collaborative and influential working style with internal and external teams.
* Capable of managing multiple projects to completion.
Work Location
* 2 days a week in our Cambridge or Porto office.
Why us?
An exciting job opportunity awaits you!
MoonLake is a dynamic and innovative company pushing the boundaries of possibility. We seek passionate individuals to join our stellar team.
What we offer:
* Learning environment with experienced professionals.
* Opportunity to contribute to ground-breaking healthcare projects.
* Flexible, hybrid work arrangements promoting work-life balance.
* Clear career progression paths.
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.
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