Mission• The Senior Clinical Development Scientist is an important member of the Global Project Team, Strategic Clinical Team and Clinical Study Teams working cross functionally with other R&D and non-R&D departments such as Regulatory and Patient Safety, Disease Biology, Global Market Access and Pricing, Medical affairs, Marketing, Market Companies and Business Development.
• The Senior Clinical Development Scientist collaborates closely with Global Clinical Program Lead (GCPL) on all scientific and clinical aspects of the clinical program, as well as providing scientific/clinical support for the program/clinical studies execution. This role supports clinical programs within Global Clinical Development with regular consultations with the GCPL and Early/Late-stage Clinical Development Directors.
• This position demands analysis/synthesis and communication skills, with some level of autonomy.
Tasks & Responsibilities• Work cross-functionally within project/study teams to ensure the clinical strategy is translated into the development of the study concept document, study protocol and related documents.
• Support GCPL in preparation of scientific meetings
• Provide regular scientific disease state updates, monitoring of the scientific aspects of the competitive landscape (maintain the scientific updates of competitors in targeted indications which will be the basis for Early Disease Roadmaps [EDR] and Target Product Profile [TPP] definition, key strategic documents for evaluation of new external and internal opportunities).
• Analyze and present clinical trial results when required (internal Committees)
• Support the scientific review in potential due diligences during evaluation of external opportunities (External Innovation and Licensing department), and presenting and defending conclusions to proper decision-making Committees.
• Support the GCPL on the design of clinical development plans (focus on critical review of studies from competitors and aiming to optimize the clinical quality of the clinical design) for internal assets and for evaluation of external opportunities.
• Provides content to the clinical study synopsis with guidance from GCPLs and is responsible for accuracy of the scientific content of the study protocol, amendments, CSRs, ICF, CRF, as well as scientific/clinical content of key internal or external project related documents (eg. IB, briefing package for regulatory authorities, responses to Health Authorities for clinical studies approvals, ISE, ISS, publication).
• Provides support for the definition and review of protocol deviations.
• Support the GCPL in data analysis, data review and content proposals for the publications.
• Coordinate transversal training activities with the objective of increasing the scientific knowledge related to projects and programs (new methodologies, regulatory actualizations, new trial designs)
• Core member of the Strategic Clinical Team and Clinical Study Team
• Permanent member of the Global Project Team.
Education & Experience• Bachelor's degree in life sciences or equivalent (e.g., Pharmacy, Biology, Molecular Medicine, Bioengineering).
• Advanced Degree (PhD or master's degree in Pharmaceutical Medicine) valuable.
• Prior experience in immunology or dermatology may be also considered.
• Minimum of 3 years of Pharmaceutical Industry experience in drug development,
• Demonstrates understanding of methodology in the design, conduct, review and interpretation, and presentation of clinical research.
• Fluency in English (written and spoken), Proficiency with MS Office.
Skills & Competences• Data analysis, communication, and presentations skills in team settings and in formal presentations to internal teams and Committees.
Values Care : we listen & empathize, we value diverse perspectives & backgrounds and we help each other succeed. Courage : we challenge the status quo, we take full ownership and we learn from our success & failures Innovation : we put the patient and customer at the center, we create novel solutions and we empower entrepreneurial mindsets. Simplicity : we act decisively and avoid over-analysis, we understand why before we act and we are agile & keep things simple.
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