Chiesi USA, Inc.
Sr. Director, Clinical Programs, Global Rare Diseases
Chiesi USA, Inc., Boston, Massachusetts, us, 02298
Overview
Sr. Director, Clinical Programs, Global Rare Diseases role at Chiesi USA, Inc. Join to apply for the Sr. Director, Clinical Programs, Global Rare Diseases role at Chiesi USA, Inc. Chiesi USA is based in Parma, Italy. Chiesi is a research-focused biopharmaceutical group with 90 years of experience, operating in 31 countries. The group employs 8,000+ people and is committed to sustainability and ethical practice as a Benefit Corporation and a certified B Corp. Diversity, inclusion, and equal opportunity are at the heart of who we are. We are a vibrant ecosystem of passionate, talented individuals united by strong values. Responsibilities
Ensure clinical programs are adequately planned, designed, and executed to gain product approval in multiple geographies by overseeing clinical activities across programs. Lead, mentor, and develop the clinical team personnel under their responsibility. Support the Head of Clinical Development in coordinating efficient planning and utilization of GRD Clinical Development resources and budget prioritization, and set future strategy for the group. Provide leadership, oversight, and guidance to a team of Clinical Program Leaders, Clinical Research Physicians and Clinical Research Scientists and/or Scientific Medical Writers. Contribute to fostering an environment of high-quality drug development and clinical excellence within GRD R&D. Provide clinical oversight across studies and programs from study design and conduct through interpretation and regulatory submissions. Develop and oversee robust, well-designed Clinical Development Plans and ensure plans and deliverables are achieved on time and on target. Assist in shaping the asset strategy within the R&D plan, considering the competitive landscape. Serve on the Clinical Development Leadership Team and contribute to strategic discussions on GRD Clinical Development's future vision. Assign team members to projects, oversee recruitment, and provide training or coaching as needed. Stay current on internal and external developments relevant to Clinical Development; maintain awareness of disease-area influences. Maintain high standards of scientific and clinical knowledge in assigned therapeutic areas. Advise on lifecycle management and post-marketing commitments for assigned products. Communicate with Health Authorities as appropriate and represent Chiesi and patients ethically and professionally. Drive ongoing data generation and identify opportunities for unmet medical needs within the therapeutic area(s). Participate in process, structure, system, tool, and resource improvements; foster talent management and attract top talent to Chiesi. Interface with Research and collaborate with Project Leaders to deliver portfolio and project priorities; may serve as deputy for the Head of Clinical Development for key activities and meetings. Provide 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 in Clinical Development (trial design, conduct, interpretation). Education
Medical Doctor Degree is required. Preferred Specializations (not binding): Pediatrics, Neurology, Neuropsychiatry. Past experience in Rare Diseases and development of treatment for rare pediatric/neurologic indications is desirable. What we offer
No matter where your path starts at Chiesi, it leads to inspiring possibilities. Your future is our focus, and we are committed to nurturing your development in our dynamic, friendly environment with access to resources and training. We provide top-class benefits, including comprehensive healthcare programs, work-life balance initiatives, relocation support, and a competitive salary package with bonuses and market-aligned benefits. Flexible working arrangements, remote options, and tax assistance for foreign colleagues are available. Chiesi USA is an equal opportunity employer committed to hiring a diverse workforce. All qualified applicants receive consideration without regard to race, national origin, age, sex, religion, disability, marital status, veteran status, or any other basis protected by law. Seniority level
Director Employment type
Full-time Job function
Research, Analyst, and Information Technology Industries: Pharmaceutical Manufacturing
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Sr. Director, Clinical Programs, Global Rare Diseases role at Chiesi USA, Inc. Join to apply for the Sr. Director, Clinical Programs, Global Rare Diseases role at Chiesi USA, Inc. Chiesi USA is based in Parma, Italy. Chiesi is a research-focused biopharmaceutical group with 90 years of experience, operating in 31 countries. The group employs 8,000+ people and is committed to sustainability and ethical practice as a Benefit Corporation and a certified B Corp. Diversity, inclusion, and equal opportunity are at the heart of who we are. We are a vibrant ecosystem of passionate, talented individuals united by strong values. Responsibilities
Ensure clinical programs are adequately planned, designed, and executed to gain product approval in multiple geographies by overseeing clinical activities across programs. Lead, mentor, and develop the clinical team personnel under their responsibility. Support the Head of Clinical Development in coordinating efficient planning and utilization of GRD Clinical Development resources and budget prioritization, and set future strategy for the group. Provide leadership, oversight, and guidance to a team of Clinical Program Leaders, Clinical Research Physicians and Clinical Research Scientists and/or Scientific Medical Writers. Contribute to fostering an environment of high-quality drug development and clinical excellence within GRD R&D. Provide clinical oversight across studies and programs from study design and conduct through interpretation and regulatory submissions. Develop and oversee robust, well-designed Clinical Development Plans and ensure plans and deliverables are achieved on time and on target. Assist in shaping the asset strategy within the R&D plan, considering the competitive landscape. Serve on the Clinical Development Leadership Team and contribute to strategic discussions on GRD Clinical Development's future vision. Assign team members to projects, oversee recruitment, and provide training or coaching as needed. Stay current on internal and external developments relevant to Clinical Development; maintain awareness of disease-area influences. Maintain high standards of scientific and clinical knowledge in assigned therapeutic areas. Advise on lifecycle management and post-marketing commitments for assigned products. Communicate with Health Authorities as appropriate and represent Chiesi and patients ethically and professionally. Drive ongoing data generation and identify opportunities for unmet medical needs within the therapeutic area(s). Participate in process, structure, system, tool, and resource improvements; foster talent management and attract top talent to Chiesi. Interface with Research and collaborate with Project Leaders to deliver portfolio and project priorities; may serve as deputy for the Head of Clinical Development for key activities and meetings. Provide 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 in Clinical Development (trial design, conduct, interpretation). Education
Medical Doctor Degree is required. Preferred Specializations (not binding): Pediatrics, Neurology, Neuropsychiatry. Past experience in Rare Diseases and development of treatment for rare pediatric/neurologic indications is desirable. What we offer
No matter where your path starts at Chiesi, it leads to inspiring possibilities. Your future is our focus, and we are committed to nurturing your development in our dynamic, friendly environment with access to resources and training. We provide top-class benefits, including comprehensive healthcare programs, work-life balance initiatives, relocation support, and a competitive salary package with bonuses and market-aligned benefits. Flexible working arrangements, remote options, and tax assistance for foreign colleagues are available. Chiesi USA is an equal opportunity employer committed to hiring a diverse workforce. All qualified applicants receive consideration without regard to race, national origin, age, sex, religion, disability, marital status, veteran status, or any other basis protected by law. Seniority level
Director Employment type
Full-time Job function
Research, Analyst, and Information Technology Industries: Pharmaceutical Manufacturing
#J-18808-Ljbffr