Head Of Clinical Operations Milano

Head Of Clinical Operations
Milano
Lombardia, Milano

We are seeking an exceptional Head of Clinical Operations to lead our clinical operations team in driving excellence across early- and late-phase oncology programs.

This role requires a seasoned leader with a strong track record in clinical operations strategy, vendor management, and regulatory filings.

As a senior leader, you will oversee all aspects of clinical operations, including trial design, CRO partnerships, budget negotiations, and regulatory submissions.

You will bring strategic insight, operational expertise, and polished communication to an adaptive and fast-paced environment.

Key Responsibilities Strategic Leadership :

Develop and implement clinical operations strategies for early- and late-phase oncology trials.

Oversee the preparation of integrated timelines, recruitment forecasts, and budget planning for global studies.

Lead scenario planning to mitigate risks and maximize feasibility, ensuring alignment with corporate goals.

Vendor and Budget Management :

Aggressively manage CRO relationships, from selection and vetting to contract negotiation and performance oversight.

Ensure cost-effective study execution while maintaining high-quality deliverables.

Regulatory and Submission Expertise :

Drive clinical operations for INDs, NDAs, and wBLAs , and oversee preparation for regulatory inspections (FDA, EMA).

Serve as a key leader in ensuring compliance with regulatory requirements across all stages of clinical development.

Lead and inspire a high-performing clinical operations team, fostering collaboration across cross-functional groups.

Build capabilities to deliver complex oncology trials, ensuring operational excellence at all levels.

Operational Execution :

Optimize protocols to improve feasibility and ensure seamless execution of first-in-human (FIH) studies and early-phase trials.

Oversee trial startup and execution, ensuring alignment with integrated timelines and recruitment goals.

Cross-Functional Collaboration :

Act as a key interface between Clinical Development, Regulatory, and Medical Affairs teams.

Drive effective communication and decision-making in matrixed environments.

Requirements and Qualifications Education :

PhD in life sciences or a related field is strongly preferred.

Experience :

10+ years of experience in clinical operations, with a focus on oncology in large pharma or biotech.

Proven track record in leading early- and late-phase oncology trials, including FIH startup and IND submissions.

Extensive experience in regulatory submissions (NDA, BLA, wBLA) and regulatory inspections (FDA, EMA).

Skills and Competencies :

Strong expertise in CRO selection, contract negotiation, and performance management.

Exceptional strategic planning skills, including mapping timelines, recruitment rates, and budget forecasts.

Proactive mindset with the ability to anticipate challenges and prepare contingency plans.

Polished communication and leadership skills, with the ability to influence across all levels of the organization.

Demonstrated ability to thrive in an adaptive, fast-paced environment.

Languages: English (Oral and written), Italian (optional)

Seniority level Mid-Senior level

Employment type Full-time

Job function Research and Science

Industries Pharmaceutical Manufacturing and Biotechnology Research

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