Clinical Development Leader

4 weeks ago


Cary, North Carolina, United States Chiesi USA Full time
About the Role

We are seeking a highly skilled Clinical Development Leader to join our team at Chiesi USA. As a key member of our R&D department, you will play a critical role in defining the target disease profile, target product profile, and development and life cycle strategies for our projects.

As a Clinical Development Leader, you will lead the Clinical Development Team in the design and execution of the clinical development plan from Phase I to Phase IV. You will be responsible for all clinical aspects related to the Clinical Trial Dossier, including clinical modules, briefing books, scientific advice, meetings with regulatory agencies, and more.

You will serve as the principal internal clinical resource for R&D concerning the disease area and project, working with other members of the Core Team to raise disease awareness and product knowledge levels within Chiesi.

Key Responsibilities:

  • Develop the Target Product Profile and Clinical Development strategy as a member of the Core Team
  • Coordinate alignment and agreement on Clinical Development Plan matters with the Clinical Development 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 for 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 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 Clinical Development Plan elements
  • Ensure accurate and timely documentation of all actions and decisions related to the Clinical Development Plan

Requirements:

  • 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 clinical investigator track record
  • Experience within the respiratory therapeutic area is highly preferred
  • Fluent written and verbal communication skills in English
  • Ability to interact with academic and regulatory experts with confidence, integrity, and persuasion
  • Strong business acumen, able to see the big picture and weigh pros and cons and drive towards an informed decision
  • Strong ability in analyzing and interpreting complex data sets
  • Leading a cross-functional team, working in a matrix environment, problem-solving, motivating team members, and providing a safe environment for the expression and exchange of innovative thoughts and ideas
  • Courage to take initiative and learn from failures and setbacks
  • Excellent communication with peers, stakeholders, Sr. managers, and teammates

What We Offer:

Chiesi USA is a specialty pharmaceutical company focused on developing and promoting products for the hospital, adjacent specialty, and rare disease markets. We offer a competitive benefits package, opportunities for professional growth and development, and a collaborative work environment.

Join our team and contribute to the development of innovative treatments that improve the lives of patients worldwide.



  • Cary, North Carolina, United States Chiesi USA Full time

    About UsChiesi 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,...


  • Cary, North Carolina, United States Chiesi USA Full time

    About Chiesi USAWe are a specialty pharmaceutical company focused on developing and promoting products for the hospital, adjacent specialty and rare disease markets. Our mission is to improve people's quality of life by acting responsibly towards society and the environment.Our ValuesWe share an entrepreneurial spirit and act as a force for good, pursuing...


  • Cary, North Carolina, United States CenterWell Full time

    Job SummaryWe are seeking a highly skilled RN Clinical Manager to lead our home health operations team. As a key member of our leadership team, you will be responsible for overseeing the delivery of high-quality patient care, managing clinical operations, and ensuring compliance with regulatory requirements.Key ResponsibilitiesLead and manage a team of...


  • Cary, North Carolina, United States YMCA OF THE TRIANGLE AREA Full time

    **Job Summary:**We are seeking a motivated and dedicated Youth Program Leader to join our team at the YMCA of the Triangle Area. As a Youth Program Leader, you will be responsible for leading and developing relationships with youth participants in our program.**About the Role:Lead and supervise a group of elementary and/or middle school students in various...

  • Physical Therapist

    2 weeks ago


    Cary, North Carolina, United States BreakThrough Physical Therapy Full time

    BreakThrough Physical Therapy is a member of the Confluent Health family of outpatient physical and occupational therapy companies. We are committed to developing and educating today’s highly effective clinicians and providing them with career development pathways to become industry leaders. As a Physical Therapist at BreakThrough, you will have the...


  • Cary, North Carolina, United States Ladgov Corporation Full time

    Job Title: Jewish RabbiWe are seeking a qualified Jewish Rabbi to provide spiritual guidance and education to our community.Job Summary:The successful candidate will be responsible for leading worship services, providing religious instruction, and promoting Jewish values and traditions.Key Responsibilities:Lead worship services and provide spiritual guidance...


  • Cary, North Carolina, United States The Dignify Solutions LLC Full time

    Job SummaryAs a seasoned Java Full Stack Senior Leader, you will lead the development of complex, cloud-native applications using Java and related technologies. You will be responsible for designing and implementing scalable, secure, and high-quality software solutions that meet the needs of our clients. Your expertise in DevOps practices and tooling, such...


  • Cary, North Carolina, United States Dude Solutions Full time

    About the RoleThe Principal Software Architect will provide Enterprise Architecture leadership, vision, and deliver efficient architecture designs, using technology, evaluating design alternatives, and balancing long and short-term views and conflicting requirements. This is a great opportunity for a leader to bring their experience, discernment, and...

  • Software Developer

    4 weeks ago


    Cary, North Carolina, United States SAS Full time

    About the JobThe Customer Intelligence R&D team at SAS is seeking a skilled Full-Stack Software Developer to contribute to the advancement of our data engineering framework, support various value-stream teams, and drive innovation in data pipelines, orchestration, and manipulation of customer event data.As a key member of the Data Engineering team, you will...


  • Cary, North Carolina, United States OnLogic Full time

    About the Role:We are seeking a highly skilled Strategic Account Manager to join our team at OnLogic. As a sales leader, you will be responsible for driving exponential revenue growth and executing strategic go-to-market initiatives. You will have the ability to construct and execute a successful business development strategy, manage complex customer...


  • Cary, North Carolina, United States YMCA OF THE TRIANGLE AREA Full time

    POSITION SUMMARY:The Northwest Cary YMCA is seeking a highly motivated and experienced Youth Program Leader to join our team. As a Youth Program Leader, you will be responsible for leading and developing relationships with youth participants in the program, while ensuring a safe and fun environment for all.This is a part-time position, typically working...

  • Pharmacy Technician

    4 weeks ago


    Cary, North Carolina, United States Actalent Full time

    Job Title:Pharmacy TechnicianJob Summary:Actalent is seeking a Pharmacy Technician to support our clinical operations team. The successful candidate will work on assignments that are moderately complex in nature, requiring judgment to resolve problems and make routine recommendations.Key Responsibilities:• Review contents of referral to ensure complete and...


  • Cary, North Carolina, United States Zifo Full time

    Job SummaryZifo is seeking a Business Development Manager to join their Commercial team. This role will focus on expanding relationships with new clients and managing different aspects of the business development process.Key Responsibilities:Develop and expand relationships with clients new to ZifoProvide management and support for new business pipeline...

  • Oracle Apex Developer

    4 weeks ago


    Cary, North Carolina, United States ClinDCast LLC Full time

    Job Title: Oracle Apex DeveloperJob Summary:We are seeking an experienced Oracle APEX Developer to join our team at ClinDCast LLC. As an Oracle APEX Developer, you will be responsible for designing, developing, and maintaining Oracle APEX applications to meet business requirements.Key Responsibilities:Lead design, develop, and maintain Oracle APEX...


  • Cary, North Carolina, United States Riverbed Technology Full time

    Job Title: Senior AI Software DeveloperWe are seeking a highly skilled Senior AI Software Developer to join our team. As a key member of our engineering team, you will be responsible for designing, developing, and implementing cutting-edge AI solutions.### Key Responsibilities* Design and develop AI services, algorithms, and machine learning models* Train,...


  • Cary, North Carolina, United States Epic Games Full time

    Job Title: Senior Full Stack DeveloperAbout the Role:We are seeking a highly skilled Senior Full Stack Developer to join our Service Management Platform team. As a key member of our team, you will be responsible for designing, developing, and maintaining our service management platform based on Backstage. Your expertise in full-stack development, including...


  • Cary, North Carolina, United States Epic Games Full time

    About the RoleEpic Games is seeking a highly skilled Business Development Manager to join our Unreal Industry Solutions team. As a key member of our team, you will be responsible for driving the adoption and licensing of our industry-leading Real-Time 3D technology across the Fashion, Retail, and CPG market verticals in North America.Key...


  • Cary, North Carolina, United States WakeMed Full time

    About WakeMed:WakeMed is a leading healthcare provider in Wake County, committed to delivering exceptional patient care and improving the health and well-being of our community. Our nurse residency program is designed to support the growth and development of new graduate nurses, providing a comprehensive and supportive environment for professional and...


  • Cary, North Carolina, United States Parker Hannifin Corporation Full time

    Job SummaryWe are seeking a highly skilled Digital Transformation Leader to lead our IT Infrastructure and Operations team. As a key member of our organization, you will be responsible for driving the development and management of our IT infrastructure and operations strategy.About the RoleThe ideal candidate will have 8+ years of experience in IT...


  • Cary, North Carolina, United States Allucent Full time

    About the RoleWe are seeking an experienced Clinical Systems Product Manager to join our team at Allucent. As a key member of our clinical operations team, you will be responsible for supporting and optimizing our clinical systems to ensure seamless execution of clinical trials.Key Responsibilities:Collaborate with business stakeholders to understand needs...