Sr. Director, Clinical Programs, Global Rare Diseases

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Department: GRD Clinical Development

Job Type: Direct Employee

Business Area: R&D, Pharmacovigilance & Regulatory Affairs

Contract Type:
Permanent

Location:

Boston, MA, US

Chiesi USA

Based in Parma, Italy, Chiesi is an international research-focused biopharmaceutical group with 90 years’ experience, operating in 31 countries. More than 8,000 employees across the group are united by a singular purpose: promoting a healthier world for our people, patients, and the planet. This is what drives us as we research, develop, and market innovative drugs across our main therapeutic areas.

Discover more here.

At Chiesi we are thinking generations ahead, driving sustainable innovation with purpose. This fosters a culture of reliability, transparency, and ethical behaviour at every level. As a Benefit Corporation and a certified B Corp, we have embedded sustainability in our bylaws and continuously measure our impact.

Diversity, inclusion, and equal opportunity are at the heart of who we are. We believe our differences make us stronger. We are a vibrant ecosystem of passionate, talented individuals united by strong values, each bringing unique perspectives that help us to continuously challenge the status quo for the better.

Who we are looking for

• 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

• 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

• 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.
• Experience in Clinical Development (clinical trial design, conduct and interpretation).

• 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…