Director, Clincial Operations

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pSelect how often (in days) to receive an alert: /p pAlfasigma is a privately held global healthcare company founded over 75 years ago in Italy, where it remains headquartered today in Bologna and Milan. The Group operates in over 100 markets spanning Europe, North and South America, Asia, and Africa. /p pOver three years ago, we embarked on a transformative journey to become ba truly global innovative healthcare company with a leading focus on Gastrointestinal (GI) health /b. We have experienced remarkable growth, nearly doubled our revenues, expanding geographically, and integrating several key acquisitions. We have also evolved our portfolio, expanded into rare and specialty segments, and strengthened our pipeline and people's capabilities. /p h3But our journey is far from complete! /h3 pIn fact, this is just the beginning of a bold new chapter in Alfasigma's history. We are committed to advancing innovation and leveraging our deep expertise to provide better health and a better quality of life for patients and consumers worldwide and expand our reach across diverse markets. /p h3Scope of the Role /h3 pAs Director, Global Clinical Operations, you will provide both strategic and operational leadership for the execution of global clinical development programs. You will be responsible for ensuring that clinical trials are delivered on time, within budget, and in full compliance with regulatory, quality, and company requirements. /p pActing as a key member of cross-functional Clinical Development and Program Teams, you will drive operational excellence across multiple studies and clinical programs, partnering closely with internal stakeholders and external service providers to support the successful development of innovative therapies. In addition, you will lead and develop Clinical Operations talent, foster a culture of quality and continuous improvement, and contribute to broader Development organization initiatives aligned with Alfasigma's values and strategic objectives. /p h3Your Role /h3 pAs Director, Global Clinical Operations, you will: /p ul liProvide strategic oversight and operational leadership for one or more global clinical programs across Phase I-IV studies. /li liEnsure clinical trials are delivered according to timelines, budgets,



quality standards, and applicable regulatory requirements. /li liLead the planning, execution, monitoring, and delivery of clinical studies to achieve program and departmental objectives. /li liPartner closely with Clinical Development, Medical, Regulatory Affairs, Biostatistics, Data Management, Pharmacovigilance, and other key functions to align operational execution with development goals. /li liServe as the Clinical Operations representative within Clinical Development Teams and Program Teams. /li liDrive study feasibility assessments, operational planning, risk identification, and mitigation activities. /li liOversee and manage Contract Research Organizations (CROs) and vendors, ensuring performance, governance, budget control, and issue resolution. /li liLead contract oversight and CRO governance activities across complex global programs. /li liMonitor study progress through key performance indicators and proactively address operational challenges. /li liEnsure compliance with ICH-GCP guidelines, FDA, EMA, and other applicable global regulatory requirements. /li liProvide direct line management, coaching, mentoring, performance development, and resource planning for Clinical Operations team members. /li liChampion a culture of quality, accountability, collaboration, and continuous improvement across teams. /li liContribute to departmental process enhancements, inspection readiness activities, and strategic Development initiatives. /li liReview and contribute to study protocols, clinical study reports, operational plans, and other critical study documentation. /li liPresent study and program updates to senior leadership and external stakeholders as required. /li liSupport organizational goals by promoting a strong "One Team" mindset focused on patients, science, and business success.



/li /ul h3Who Are You /h3 pYou are an experienced Clinical Operations leader with a strong track record of delivering global clinical trials in pharmaceutical or biotechnology environments. You combine strategic thinking with operational excellence, successfully leading teams, managing CRO partnerships, and driving clinical programs from planning through execution. /p pWhat you bring: /p ul liBachelor's degree in a scientific or health-related field; advanced degree preferred. /li li10+ years of experience in Clinical Operations, including at least 5 years within a pharmaceutical or biotech sponsor organization. /li liPrevious people management experience, with a passion for coaching and developing talent. /li liProven expertise in managing Phase I-IV clinical trials and global clinical programs. /li liStrong knowledge of ICH-GCP, FDA, EMA, and global regulatory requirements. /li liDemonstrated success managing CROs, vendors, budgets, timelines, and study risks. /li liExcellent leadership, project management, communication, and stakeholder management skills. /li liExperience working effectively in global, cross-functional, and matrix organizations. /li liProficiency with clinical trial systems (eTMF, EDC, Veeva) and Microsoft Office applications. /li liA proactive, collaborative, and solution-oriented mindset, with a strong commitment to quality and continuous improvement. /li liFluent English and willingness to travel internationally (approximately 15%). /li /ul pLocation: Europe and US (East Coast Time Zone) /p h3Why Join Alfasigma: /h3 pbAt Alfasigma, we foster a culture where the courage to innovate is key to our success. /bbr/We offer a competitive salary, comprehensive benefits, and extensive opportunities for professional growth and development. /p pOur commitment to people and patients is at the heart of everything we do. We value diversity and welcome individuals with unique perspectives and experiences. We believe that open-mindedness, collaboration, and a shared passion for innovation are essential to achieving meaningful progress. /p pbJoin Alfasigma and become part of a forward-thinking team dedicated to shaping the future of the pharmaceutical industry. /b /p #J-18808-Ljbffr

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/89lty1