Global Clinical Program Director
hace 4 semanas
As a Global Clinical Program Lead at Almirall Hermal, you will be accountable for the continuous benefit-risk evaluation of one or more clinical assets. This involves providing overall clinical/medical leadership, including clinical development strategy, and overseeing the implementation of a clinical development plan for assigned projects.
Key Tasks:
• Define the Clinical Development Plan, including clinical development strategy and study concept documents.
• Lead the Strategic Clinical Team within Global Clinical Development and serve as a primary source of clinical/medical accountability and oversight for assigned clinical studies.
• Develop and implement a clinical development strategy, including defining study concept documents and reviewing and approving critical study documents.
• Provide medical input and support to study teams for clinical development trials, in line with defined clinical development strategy and target product profile.
• Deliver and interpret clinical study results, and develop content proposals for publications.
Interactions:
• Collaborate with cross-functional teams, including Regulatory and Patient Safety, Disease Biology, Global Market Access and Pricing, Medical Affairs, Marketing, Market Companies, and Business Development.
• Represent Global Clinical Development at meetings with Health Authorities and other external stakeholders, in consultation with Early or Late-Stage Global Clinical Development Director.
• Ensure clinical review/oversight of potential due diligences during evaluation of external opportunities, presenting and defending conclusions to appropriate decision-making Committees, in consultation with Early or Late-Stage Global Clinical Development Director.
Requirements:
• Medical degree. Specialty in dermatology is a plus. Advanced Degree (PhD or master's degree in Pharmaceutical Medicine) is valuable.
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