Disease Area Clinical Operations Lead
Cary, NC, US
About us
Based in Parma, Italy, Chiesi is an international research-focused pharmaceuticals and healthcare group with over 85 years’ experience, operating in 30 countries with more than 6,000 employees (Chiesi Group). To achieve its mission of improving people’s quality of life by acting responsibly towards society and the environment, the Group research, develops and markets innovative drugs in its three therapeutic areas: AIR (products and services that promote respiration, from new-born to adult populations), RARE (treatment for patients with rare and ultra-rare diseases) and CARE (products and services that support special care and consumer-facing self-care).
We are proud to be the largest global pharmaceutical group to be awarded B Corp Certification, a recognition of high social and environmental standards. We are a reliable company that adopts and promotes transparent ethical behavior at all levels.
We are committed to embrace diversity, inclusion and equal opportunities. In fact, we are a global family made up of different cultures, different genders, generations, ethnicities, abilities, sexual identities and many other enriching diversities.
Chiesi USA
Chiesi USA is a specialty pharmaceutical company focused on developing and promoting products for the hospital, adjacent specialty and rare disease markets. We are a B Corp™ and Benefit company awarded Top Employer status for six consecutive years and certified as a Great Place to Work.
At Chiesi, we share an entrepreneurial spirit and act as a force for good, pursuing high social and environmental standards, to ensure the wellbeing of our people, patients, and communities. We offer a work environment where professionals have the opportunity to build a purposeful career focused on helping others while achieving a fulfilling work-life balance, meeting exciting challenges, and engaging in important and rewarding work.
What we offer
Chiesi offers competitive benefits, services, and programs that enrich the personal and professional lives of our employees. Our shared values of passion, innovation, trust and integrity bring out the individual talents and diverse perspectives of each of our colleagues. Our environment encourages each individual to reach his or her full potential and drive outstanding results. We celebrate that “Every one of us is different. Every one of us is Chiesi."
Who we are looking for
Purpose
The role is responsible for integrating high-level expertise across studies to ensure a cohesive program vision. It involves coordinating the operational management of projects, overseeing the entire value chain of Clinical Operations, and maintaining program budgets. The position also includes line management of Clinical Project Managers (CPMs), ensuring adherence to timelines and budgets, and contributing to strategic planning and governance. Additionally, the role requires managing vendor selection, ensuring compliance with regulatory standards, and supporting documentation and training efforts.
Main Responsibilities
- Program Integration: Ensure the connection between high-level expertise across studies and the overall program vision. Integrate early, late phase, and Real-World Evidence (RWE) components into a cohesive program.
- Operational Coordination: Coordinate the operational management of assigned projects to align with Chiesi goals and medical/scientific standards. Oversee the entire value chain of Clinical Operations, ensuring continuity in development.
- Team Leadership: Serve as the main point of contact for the Clinical Development Plan (CDP) team, with Clinical Project Managers (CPMs) as subject matter experts. Perform line management of CPMs, ensuring their adherence to scope, timelines, and budget. Define yearly objectives for CPMs and conduct periodic assessments, including individual performance evaluations and IDP reviews.
- Budget Management: Maintain and manage the program budget.
- Project Planning: Set up and manage Gantt charts for clinical operations activities, coordinating all phases and RWE. Contribute to the CDP definition, including operational aspects, geographic feasibilities, costs, and timelines.
- Vendor Management: Supervise and ensure the selection of fit-for-purpose Clinical Research Organizations (CROs) and providers.
- Documentation and Compliance: Participate in the preparation of documentation for electronic Common Technical Document (eCTD) submissions. Support CPMs in operational decisions to ensure projects meet quality standards and regulatory requirements. Provide strategic and operational input during study design and Clinical Protocol Approval Committee (CPAC) preparation.
- Governance and Reporting: Act as a core member of strategic governance bodies, interacting with all functions supporting the CDP. Contribute to updates for various review forums and committees. Report to stakeholders and top management at critical study milestones.
- SOPs and Training: Involved in writing/reviewing SOPs and working instructions, and completing assigned trainings.
Experience Required
- At least 5 years of experience in a Clinical Research Project Management in a pharmaceutical company or CRO.
- Track record of achievements in successful planning and execution of at least 10 clinical studies.
- Previous managerial experience is recommended.
- Knowledge of principles of clinical study design, Clinical Research Statistics, planning tools and planning principle and ICH/GCP and company SOPs.
- Demonstrated proficiency in Written, Verbal and Face-to-face communication to effectively present information to and influence decision making of managers, working partners (local and global), and government agencies.
- Ability to successfully manage multiple tasks and multifunctional resources concurrently while maintaining high attention to detail while responding to rapidly changing priorities and aggressive deadlines.
Education
BS/BA Degree in Life Sciences (biological science, pharmacy or other health related discipline) or equivalent
Chiesi USA is an equal opportunity employer committed to hiring a diverse work force at all levels of our business. All qualified applicants receive consideration for employment without regard to race, national origin, age, sex, religion, disability, sexual orientation, marital status, veteran status, gender identity or expression or any other basis protected by local, state or federal law. This policy applies with regard to all aspects of one’s employment, including hiring, transfer, promotion, compensation, eligibility for benefits and termination.
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