Chiesi is an international research-focused biopharmaceutical group with 90 years' experience, operating in more than 30 countries, with its Headquarter in Parma, Italy. 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 and inclusion 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.Air and Care FranchiseWithin the three Business Units (Discover more here), Air and Care Franchises are responsible for the development and implementation of the Therapeutic Area Strategies. Each Franchise is organized by stage of development with fully empowered and enhanced teams of: Pipeline Development Team - focused on delivering innovation and programs leadership accountabilities in close collaboration with R&D, Commercial Portfolio Management Team - focused on maximizing the benefit for the patients and the full potential of marketed / close-to-launch assets, including Life Cycle Management strategies.Medical Affairs, Value & Access, and Business Excellence & Customer Experience Global functionsWithin these departments, you will actively support the Air and Care Franchises businesses. These units are responsible for the development and implementation of the Therapeutic Area Strategies. Each Franchise is organized by stage of development with fully empowered and enhanced teams of: Pipeline Development and Commercial Portfolio Management.Who we are looking forThis is what you will doWithin the Global Medical Affairs and reporting to the Vice-President, GMA Top 5 Strategic Partner, Evidence Generation & Chief Scientific Officer, the Clinical Operations Manager leads the operational activities and oversees execution of GMA-generated data, as part of the Evidence Generation Plans, with a focus on respiratory products.You will be responsible for
Leading and overseeing the GMA execution of customer insight-driven studies (all areas) in support to patient centric effortsCollaborating closely with the GMA therapeutic areas and patient-centered outcomes teams, leading the execution of the studies defined in the Evidence Generation Plans and providing operational expertise and input for assigned programsChallenging study team to ensure operational feasibility, inclusive of patient, site burden and budgetProviding guidance and act as GMA reference point for providers/CROs, in close cooperation with GMA therapeutic areasManaging and overseeing the contracting stage and work with Chiesi Global Legal Department throughout the planning and contract execution phaseOverseeing study budget planning and management. Validating and monitoring timelinesWorking with GMA therapeutic areas in liaising with Chiesi Global Clinical Development/Clin Ops, to oversee programs that are led by GMA but operationally executed by GCD Global Clinical Development (including alignment during strategic checkpoints and supervision of budget and timelines)Coordinating GMA operational activities for Chiesi sponsored multi-country studies involving the affiliates, directly liaising with local operations, and assuring application of company's high-quality standardsSupporting GMA therapeutic areas in the involvement of local medical affairs in study evaluation, identification of clinical sites and field based (MSLs) contribution to phase 3 and 4 clinical trialsLeading initiatives to progress modern and pragmatic data generation programs, leveraging patient insights and digital methodologies, e.g., decentralized, AI-based/Machine Learning approachesScouting new sources of data for evidence generation from different settings, going beyond the traditional clinical trials (e.g., public information, medical enquiries, insurance data, social media platforms, market research)
You will need to have
Bachelor's Degree (Life Sciences)At least 4 years of pharma industry experienceExperience in managing Clinical Trials, including interventional and non-interventional studies; coordination and tracking methodologies for data generation, including using databases; knowledge of global regulatory and compliance requirements for clinical research, e.g., US CFR, EU CTD, and ICH GCP.Knowledge of budget, contract negotiations and project managementSelf-directed, motivated and results-driven with ability to manage multiple priorities and projects Customer and quality focused with high sense of accountability and urgency to prioritize deliverables. Able to proactively identify issues and risks, analyze root cause, propose solutions, and elevate to managementDetail oriented and highly organized with excellent planning and time management skillsCollaborative with internal and external stakeholders to ensure all expectations are clearly defined and achievedEnthusiastic, energetic, with a positive, flexible, and approachable attitude, professional and team-oriented
LocationThe role is based in the HQ in Parma with hybrid working arrangements, combining presence in the office with remote working.What we offerNo 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 every step of the way.We provide top-class benefits, including comprehensive healthcare programs, work-life balance initiatives, and robust relocation support. Our salary package is competitive, comprising a basic salary, performance bonuses, and benefits benchmarked against the external market. Additionally, we offer flexible working arrangements, remote work options, and tax assistance services for foreign colleagues, all designed to help you thrive.Chiesi is an equal opportunity employer committed to hiring a diverse workforce at all levels of our business. All qualified applicants receive consideration for employment based on attitude and merit, without regard to race, national origin, age, sex, religion, disability, sexual orientation, marital status, military status, gender identity or expression, or any other basis protected by applicable laws. This policy applies to all aspects of employment, including hiring, transfer, promotion, compensation, eligibility for benefits, and termination.#J-18808-Ljbffr