Oct 26, 2022

Job Description

100,000. That’s how many patients participate in our clinical trials at any given time. Global Clinical Operations touches patients’ lives every day acting as a link between science and medicine. Envision the impact you could have as the Global Head of Study Start-Up! #GCOTransformation

The Global Head Study Start-Up (SSU) sets the objectives for the SSU organization in Global Clinical Operations (GCO) including defining and implementing strategy and key priorities, hiring and coaching team leaders, aligning internal and external partners on key tools, processes and metrics to complete the clinical trial portfolio. The role has responsibility for ensuring the Novartis portfolio delivers the fastest start up time in the industry.

Responsibilities include but are not limited to:

• Driving operational excellence, embedding innovation, and continuous improvement through leadership of agile and adaptive SSU communities of practice comprised of SSU roles and functions from across GCO at the global, hub and country levels.
• Developing an empowered organization which can navigate in a matrix environment, deliver consistently improving speed and quality, and pivot in anticipation of data driven business needs.
• Building a team culture of expertise, excellence and agility into the SSU trial execution model to optimize impact, deliver on cycle time and process delivery improvements and associate engagement.
• Providing proactive leadership through analysis of planned and actual GCO SSU data and industry benchmarking, trends, and regulations to adapt processes, tools and organization as needed to deliver results.
• Developing and optimizing SSU resourcing strategy; Hiring, onboarding, development, and retention of SSU Team; responsible for resource allocation of ~40 SSU Leads and CTCEs to support the GCO portfolio including external resource augmentation
• Leading Grant Plan strategy and oversight: steer the translation of clinical protocol visit schedule of assessments into intelligent Grant Plan and FMV cost estimations, ensuring clinical, scientific and operational requirements are reflected with accuracy.
• Setting standard methodology in establishing country and trial-specific cost benchmarks and budgets to improved efficiency, meet operational and scientific requirements, and positively influence trial operations as it pertains to cost for increasing simplicity and value. Leading effective engagement with FMV and Grant Plan vendor to ensure accuracy and continuous refinement of costs at the assessment level across countries.
• Ensure execution and delivery of all global clinical trials across all programs, in accordance with GCP, ICH, SOP’s, and regulations. Have oversight of functional budget and resource allocation and management.

Accessibility and accommodation

Novartis is committed to working with and providing reasonable accommodation to all individuals. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to receive more detailed information about the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Diversity & Inclusion / EEO

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

Minimum Requirements

• 10+ years of pharmaceutical industry experience, with previous experience in either clinical research or project management, in a Pharmaceutical Industry or CROs. Specific SSU experience preferred
• At least 6 years experience in people management and/or team leadership
• Education (minimum/desirable): University degree in life science, business or operations; Advance degree preferred
• Strong clinical and budgeting/finance experience in Pharma research or CRO with excellent understanding of clinical trial development processes and the management of clinical trials
• Thorough understanding of the international aspects of drug development process, including extensive knowledge of international standards (GCP/ICH), health authorities (FDA/EMEA), local/National Health Authorities regulations and Novartis standards
• Strong leadership and people management skills in global matrixed environment setting and proven track record to develop impactful teams and diverse profiles including manager of manager experience
• Proven expert level knowledge of and experience with operational management, and exceptional technical, analytical and quantitative problem solving skills
• Credible and confident at building relationships at the leadership level while demonstrating organizational agility. Proven ability to build strong, effective relationships with internal partners. Demonstrated effective influencing and negotiation skills at all levels.
• Data and Digital expertise. Experience working with electronic databases, clinical and/or project management planning and reporting and analytics systems.

Why consider Novartis?

766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.

We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.

We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do here at Novartis!
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Global Drug Development
United Kingdom
Research & Development
Full Time
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Global Head Study Start-Up

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