Global Clinical Lead Milano

Global Clinical Lead
Milano
Lombardia, Milano

The Global Clinical Lead plays a key role in driving the success of oncology programs, ensuring their progression from preclinical through clinical stages.

This role is integral to both the strategic and operational aspects of clinical development, providing leadership and expertise to deliver life-changing therapies to patients.

You will oversee the design, execution, and governance of clinical programs, collaborating with internal teams and external stakeholders to maintain excellence in clinical trial execution and regulatory interactions.

Strategic Leadership : Act as the clinical development leader for assigned programs, driving alignment with organizational goals and strategic priorities.

Represent the program at governance meetings and provide clear updates on progress, challenges, and milestones.

Collaborate closely with preclinical teams to integrate discovery data into clinical development plans.

Protocol Design and Execution : Contribute to the design of clinical protocols and ensure compliance with safety and regulatory standards.

Oversee the execution of clinical trials, including safety reviews, data analyses, and decision-making for dose escalation and expansion cohorts.

Ensure the preparation of high-quality regulatory documents, including briefing packages and clinical study reports.

Stakeholder Collaboration : Partner with internal teams (regulatory, CMC, and preclinical) to align on program timelines and deliverables.

Interact with investigators, CROs, and regulatory authorities to ensure efficient and high-quality trial execution.

Contribute to interactions with regulatory agencies, presenting clinical program strategies and results.

External Representation : Serve as the clinical representative in meetings with partners, investors, and stakeholders.

Present clinical program updates and outcomes at conferences, advisory boards, and other scientific forums.

Other Responsibilities: Collaborate with CRO Medical Monitors and clinical scientists to ensure high-quality medical oversight of clinical trials.

Drive the clinical team to meet project milestones while ensuring safety, scientific validity, and compliance.

Contribute to the development of key strategic documents such as clinical development plans and program-level regulatory submissions.

Support Business Development and Alliance Management teams to evaluate potential collaborations and partnerships.

Requirements and Qualifications: Education : MD or MD/PhD with board certification (or equivalent) in oncology or a related field.

Experience : At least 5 years of experience in clinical drug development, preferably in oncology.

Demonstrated ability to lead global clinical trials, including early-phase studies.

Familiarity with regulatory submission processes, including INDs, CTAs, and pivotal filings.

Skills and Competencies : Strong communication and presentation skills, with the ability to interact effectively with internal and external stakeholders.

Leadership experience in cross-functional teams, fostering collaboration and alignment.