Global Feasibility Lead/Clinical Operations Program Associate Director

#LI-Hybrid

Location: London UK and Dublin Ireland

The Global Feasibility Lead / Clinical Operations Program Associate Director is accountable for the oversight, coordination and development of early viability assessments, global feasibility assessments (pre-IMB and trial feasibility), recruitment projections and allocation strategies for the assigned trials and programs. As a key member of the GCO sub-team, you will provide precise oversight and ensure alignment with the overarching strategy and Global Clinical Operations (GCO) operational position adding directly into the feasibility strategies.

This role is based in London UK or Dublin Ireland. Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.

Key requirements

• Analyse various data sources, including clinical trial data, historical performance, publications, epidemiology, clinical trial and commercial landscape, etc.
• Provide modelling and viability analysis to support early recruitment projections and clinical trial planning
• Conduct end to end clinical trial feasibility in collaboration with the country feasibility managers, clinical trial team and medical teams
• Propose optimal country and site allocation, including associated risks and opportunities in alignment with the global program strategy
• Provide feedback on study design based on available data and feasibility insights
• Demonstrated experience in feasibility for global clinical trials.

Essential requirements

• Degree in Life Sciences or related scientific discipline
• 3 years pharmaceutical clinical drug development experience
• Solid understanding of all aspects of clinical drug development with particular emphasis on clinical trial design and trial execution
• Demonstrated experience in data driven feasibility for global clinical trials

Desirable requirements

• Ability to collaborate in a matrix environment
• Understand the Clinical Trial matrixed process from research through post marketing phase IV, health authority guidelines, country challenges as well as sources for therapeutic area data.
• Demonstrated ability to collaborate across partner functions in a matrix environment, without direct reports, but able to coordinate the activities of others.
• Has had success in identifying, proactively flagging, and resolving risks; experience with strategic scenario planning and management.
• Proven ability on strategic planning and managing operational challenges at global, regional, or country level.
• Strong ability to understand analytical data insights with proven ability to communicate background details and rationale.
• Thorough knowledge of the international aspects of drug development process, the international standards (GCP/ICH), health authority regulations, and clinical development process.
• Strong leadership and negotiation skills.

Commitment to Diversity and Inclusion / EEO paragraph

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.