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Clinical Development Leader

4 weeks ago

Cary, North Carolina, United States Chiesi USA Full time
About Us

Chiesi USA is a leading pharmaceutical company with a strong commitment to improving people's quality of life. Our research-focused approach has enabled us to develop innovative drugs in key therapeutic areas, including respiratory diseases. We are proud to be a global family made up of diverse cultures, genders, generations, ethnicities, abilities, and sexual identities.

Our R&D Team

Our R&D team is a fundamental asset for our business, consisting of integrated functional areas focusing on pipeline projects, including discovery and preclinical research, chemical manufacturing and controls, drug delivery technology, clinical development, regulatory affairs, pharmacovigilance, intellectual property, quality assurance, and R&D project and portfolio management. Our team is headquartered in Parma, Italy, with important operations in Paris, France, Chippenham, UK, Cary, US, Stockholm, Sweden, and Toronto, Canada.

Job Summary

We are seeking a Clinical Development Leader to join our cross-functional R&D global Core Team. The successful candidate will play a key role in defining the target disease profile, target product profile, and development and life cycle strategies of a given project. The Clinical Development Leader will lead the Clinical Development Plan Team in the design and execution of the clinical development plan from Phase I-IV worldwide.

Main Responsibilities
  • Develop the Target Product Profile and Clinical Development strategy as a member of the Core Team and with input from the Clinical Development Plan Team
  • Coordinate alignment and agreement on Clinical Development Plan matters with the Clinical Development Plan Team, Core Team, and Global Clinical Development Leadership Team
  • Ensure that the design of each clinical study is consistent with the Clinical Development Plan
  • Ensure that the Clinical Development Plan is in line with the approval path agreed with Regulatory Agencies and with the agreed business plan and objectives
  • Provide clinical approval (protocols, CSRs, lay summaries, clinical trial disclosure and/or deferral strategy, data sharing requests)
  • As part of the Submission Team, prepare/review Briefing Books, eCTD modules, and represent clinical aspects during interaction with Regulatory Authorities
  • Regularly update the Clinical Development Plan Team on all aspects discussed at Core Team or internal bodies
  • Secure necessary internal approvals and external endorsement (e.g., disease area experts, consultants) to the Clinical Development Plan elements
  • Ensure accurate and timely documentation of all actions and decisions related to the Clinical Development Plan
Requirements
  • A significant experience in designing and executing a comprehensive clinical research and development plan
  • At least 5 years in an R&D role in the pharmaceutical/biotech industry, or 7-10 years in academia with a clinical investigator track record
  • Experience within the asthma therapeutic area is a plus
  • Medical Doctor Degree; certification in Respiratory Diseases/Pulmonology will represent a plus
  • Fluent in English
What We Offer

You would join a dynamic, fast-growing, challenging, and friendly environment. We believe that our people are our most valuable asset, and that is why we invest in continuous training, learning, and development. We strive to continuously promote and satisfy development needs, paying particular attention to the quality of our working environment and to collective well-being. We want our people to come to work happy every day, and we know how important it is to find the right work-life balance in order to be able to give our best. That is why we offer flexible working approach, remote working, support in the relocation process, tax assistance service for foreign colleagues, and many other people-care services.