Director, Clincial Operations

Alfasigma; Bologna; In loco; EUR 120.000 - 180.000; Tempo pieno

Vantaggi offerti da questo lavoro

Competitive salary

Comprehensive benefits

Professional growth

Descrizione del lavoro

Alfasigma, headquartered in Bologna and Milan, seeks a Director, Global Clinical Operations to lead strategic and operational execution of global clinical programs across Phase I–IV, ensuring trials run on time, within budget and compliant.

You will collaborate with Clinical Development, Medical, Regulatory Affairs, Biostatistics, Data Management, Pharmacovigilance, and CROs, mentor a diverse team, and drive continuous improvement.

Competenze

• Bachelor's degree in a scientific or health-related field; advanced degree preferred.
• 10+ years of experience in Clinical Operations, including at least 5 years in sponsor organizations.
• Proven leadership experience and talent development.

Mansioni

• Provide strategic oversight and operational leadership for global clinical programs (Phase I–IV).
• Ensure trials are delivered on time, within budget, with quality and regulatory compliance.
• Lead planning, execution, monitoring, and delivery of clinical studies.
• Collaborate with Clinical Development, Medical, Regulatory Affairs, Biostatistics, Data Management, and Pharmacovigilance.
• Serve as Clinical Operations representative within Development and Program Teams.
• Drive feasibility assessments, planning, risk identification, and mitigation.
• Oversee CROs/vendors; ensure performance, budgeting, and issue resolution.
• Lead contract oversight and CRO governance across global programs.
• Monitor study progress via KPIs and address operational challenges.
• Ensure compliance with ICH-GCP, FDA, EMA, and global regulations.
• Provide line management, coaching, and resource planning for team members.
• Promote a culture of quality, accountability, and continuous improvement.
• Contribute to process enhancements and inspection readiness.
• Review study protocols, CTAs, reports, and critical documentation.
• Present updates to senior leadership and external stakeholders.

Conoscenze

Leadership

Clinical Operations

CRO management

Budget & timelines

Stakeholder management

Global program management

Formazione

Bachelor's degree

Advanced degree preferred

Strumenti

Veeva

EDC

eTMF

MS Office

Descrizione del lavoro

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Alfasigma 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.

Over three years ago, we embarked on a transformative journey to become a truly global innovative healthcare company with a leading focus on Gastrointestinal (GI) health. 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.

But our journey is far from complete!

In 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.

Scope of the Role

As 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.

Acting 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.

Your Role

As Director, Global Clinical Operations, you will:

• Provide strategic oversight and operational leadership for one or more global clinical programs across Phase I-IV studies.
• Ensure clinical trials are delivered according to timelines, budgets, quality standards, and applicable regulatory requirements.
• Lead the planning, execution, monitoring, and delivery of clinical studies to achieve program and departmental objectives.
• Partner closely with Clinical Development, Medical, Regulatory Affairs, Biostatistics, Data Management, Pharmacovigilance, and other key functions to align operational execution with development goals.
• Serve as the Clinical Operations representative within Clinical Development Teams and Program Teams.
• Drive study feasibility assessments, operational planning, risk identification, and mitigation activities.
• Oversee and manage Contract Research Organizations (CROs) and vendors, ensuring performance, governance, budget control, and issue resolution.
• Lead contract oversight and CRO governance activities across complex global programs.
• Monitor study progress through key performance indicators and proactively address operational challenges.
• Ensure compliance with ICH-GCP guidelines, FDA, EMA, and other applicable global regulatory requirements.
• Provide direct line management, coaching, mentoring, performance development, and resource planning for Clinical Operations team members.
• Champion a culture of quality, accountability, collaboration, and continuous improvement across teams.
• Contribute to departmental process enhancements, inspection readiness activities, and strategic Development initiatives.
• Review and contribute to study protocols, clinical study reports, operational plans, and other critical study documentation.
• Present study and program updates to senior leadership and external stakeholders as required.
• Support organizational goals by promoting a strong "One Team" mindset focused on patients, science, and business success.

Who Are You

You 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.

What you bring:

• Bachelor's degree in a scientific or health-related field; advanced degree preferred.
• 10+ years of experience in Clinical Operations, including at least 5 years within a pharmaceutical or biotech sponsor organization.
• Previous people management experience, with a passion for coaching and developing talent.
• Proven expertise in managing Phase I-IV clinical trials and global clinical programs.
• Strong knowledge of ICH-GCP, FDA, EMA, and global regulatory requirements.
• Demonstrated success managing CROs, vendors, budgets, timelines, and study risks.
• Excellent leadership, project management, communication, and stakeholder management skills.
• Experience working effectively in global, cross-functional, and matrix organizations.
• Proficiency with clinical trial systems (eTMF, EDC, Veeva) and Microsoft Office applications.
• A proactive, collaborative, and solution-oriented mindset, with a strong commitment to quality and continuous improvement.
• Fluent English and willingness to travel internationally (approximately 15%).

Location: Europe and US (East Coast Time Zone)

Why Join Alfasigma:

At Alfasigma, we foster a culture where the courage to innovate is key to our success.
We offer a competitive salary, comprehensive benefits, and extensive opportunities for professional growth and development.

Our 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.

Join Alfasigma and become part of a forward-thinking team dedicated to shaping the future of the pharmaceutical industry.