Clinical Strategy and Project Management

✔ Take charge of overseeing clinical development, managing the life cycle, and maintaining products within the designated scope.

✔ Conduct evaluations, planning, and reporting for global projects and studies in the relevant areas.

✔ Supervise, organize, and review clinical and scientific-pharmaceutical documents for various purposes, ensuring compliance with standard formats.

✔ Offer scientific and pharmaceutical guidance to diverse teams, including medical affairs, marketing, regulatory, and quality control.

✔ Cooperate, interact and exchange information with external experts, specialists, opinion leaders, service providers

✔ Interact and exchange information with regulatory authorities, and governmental policy makers

✔ Support preparation and implementation of company-owned instructions / standard operating procedures (SOPs) within area of expertise

✔ Identification and evaluation of product opportunities developed internally or externally in the assigned therapeutic area

✔ Guide or head diverse teams in assessing product opportunities, ensuring a comprehensive review and recommendation for global or regional clinical evaluations.

✔ Provide medical and clinical development expertise for the evaluation of internal and external R&D opportunities

✔ Evaluate suggested clinical development plans or create new ones for potential in-licensing deals, including budget and timelines. Assess products for regulatory compliance and clinical best practices.

✔ Collaborates with Global BD, Global Commercial Development, and Global R&D, offering insights for business cases on product strategy, costs, and success probabilities.

✔ Builds and sustains a robust network of experts within and outside the organization for insights into product evaluations and clinical development programs.

✔ Blend scientific, regulatory, and commercial elements to craft an effective clinical development plan, securing approval from stakeholders.

✔ Estimate costs and timelines for the clinical plan, assessing success probabilities with GCO's help. Determine key decision points for Go-No-Go choices.