Sr. Director, Clinical Programs, Global Rare Diseases

Purpose

• Ensures that clinical programs are adequately planned, design and executed to gain product approval in multiple geographies/ jurisdictions by overseeing clinical activities across programs.
• Effectively leads, mentors and develops the clinical team personnel under their responsibility
• Supports the Head of Clinical Development in coordinating the efficient planning and utilization of GRD Clinical Development resources and budget prioritization, and setting the future strategy for the group

#LI-Hybrid

Main Responsibilities

• Provide effective leadership, oversight, and guidance to team of Clinical Program Leaders, Clinical Research Physicians and Clinical Research Scientists and/or Scientific Medical Writers
• Contribute to fostering and developing an environment of high-quality drug development and clinical excellence within GRD R&D
• Provide clinical oversight, guidance and support across all relevant studies and programs from study design, conduct through to interpretation and regulatory submissions
• Responsible for the development and oversight of robust, well-designed, effective, and innovative Clinical Development Plans
• Accountable to ensure that clinical development plans, objectives, and deliverables are consistently accomplished on-time and on-target
• Supports in establishing a compelling vision for the relevant assets, assist in the positioning of the medicine within the R&D strategy taking the competitive landscape into account
• Serve on the Clinical Development Leadership Team and actively contribute to strategic discussions on the future vision of GRD Clinical Development
• Responsible for the assignment of team members to projects, recruitment, and training and/or coaching of new team members
• Remain up to date on internal and external developments, trends and other dynamics relevant to the work of Clinical Development
• Maintain a fully current view and perspective of internal/external influences and/or implications for the assigned disease area(s)
• Maintain the highest standards and levels of scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment
• Advise on strategic issues for Lifecycle management of assets and post-marketing commitments for assigned products
• Communicate with Health Authorities, as and when needed, or otherwise appropriate. Ethically, effectively, and professionally represent the interests of Chiesi and patients
• Drive ongoing data generation. Play a lead role within the assigned therapeutic area(s) to identify significant opportunities for unmet medical needs
• Participate in ongoing enhancements/development of processes, structures, systems, tools, and other resources
• Foster talent management, career development and attracting top talent to Chiesi
• Responsible for interface with Research, and to work in collaboration with the Project Leaders to deliver the portfolio and project priorities
• May serve as deputy for the Head of Clinical Development for key activities and meetings
• Support the provision of high-quality clinical input into evaluation of new opportunities and due diligence projects

Experience Required

• 4+ years of experience as Global Clinical Leader/Clinical Program Leader is required. Direct resources management experience is a plus.
  
  • Relevant experience in clinical or academic research in rare diseases or
  • Experience in Clinical Development (clinical trial design, conduct and interpretation)

Education

• Medical Doctor Degree is required; 
  
  • Preferred Specializations (not binding), Pediatrics, Neurology, Neuropsychiatry
  • Past experience in Rare Diseases is desirable as well as in development of treatment for rare pediatric/neurologic indications is considered a plus