Job Description Summary
-Influential leader within Data Operations accountable in ensuring that drug-development plans are executed efficiently, timely & with high quality The delivery of clean data with high quality and in alignment with defined Trial Data Strategy for the studies within their assigned TA will be this role’s chief purpose. This role will oversee Coding Specialists and Clinical Data Scientists. Direct reports for this role will be Associate Director, CDD. This role’s success would be measured by the performance of the key cost, cycle-time, productivity, and quality KPIs for specific therapeutic area(s) as assigned.
It is a thought leader role within Clinical Data Operations with a strong understanding of the drug development process, experience in regulatory activities with a track record of operational, organizational and technical leadership. Having led and nurtured large teams, demonstrated adeptness in managing resource demand/supply, managed team productivity on key deliverables/priority studies, are a pre-requisite of this role. Stakeholder management within CDO sub-functions like Clinical Data Strategy, Clinical Data Standards, Clinical Data Flow and Analytics and other enabling functions within GCO. Leads, contribute to and implement initiatives to establish and maintain Novartis Clinical Data Delivery as best in class in the industry.
Job Description
Major accountabilities:
- Selects, recruits, develops, manages, motivates, mentors, coaches and appraises the performance of direct reports to ensure high quality performance across their Therapeutic Arear (TA) team. Responsible for Engagement, capability development, and retention of delivery talent
- Drive productivity and efficiency measures to meet Novartis strategic imperatives and productivity targets. Actively ensures that metrics for teams' performance are in place and being met or exceeded. Take appropriate action when needed to drive corrective measures.
- Ensure balanced workload allocation across programs and teams within assigned therapeutic areas to enable predictable delivery outcomes, sustained quality, and efficient resource utilization.
- Proactively identify resourcing gaps, capacity constraints, and demand–supply risks at therapeutic area and portfolio level, and escalate with clear mitigation options (e.g., rebalancing, prioritization, recruitment) to the Head, Clinical Data Delivery.
- When required, represent Clinical Data Delivery regarding business requirements regarding selection and evaluation of computer systems (hardware & software) that relate to Clinical Data Delivery activities.
- As a member of the Data Delivery Leadership Team, this role is fully involved in all aspects of Clinical Data Delivery operations and helps develop future strategies and inputs on processes. This role will actively participate in the development of the Clinical Data Delivery objectives and key results annually. This role will develop execution plans based on the Trial Data Strategy
- Understands the needs of the different Health Authorities, ensures that group is always audit ready and participates in Health Authority inspections as required by monitoring that all assigned projects in the group comply with company, department and industry standards (e.g. Clinical Data Interchange Standards Consortium (CDISC)) and processes
- Lead adoption of delivery best practices; ensure compliance and quality targets are met for the function and support continuous improvement initiatives. Builds a strong sense of belonging & engagement, mentor, and coach Program Delivery Lead roles for leadership readiness in matrix environment and creates a team founded on excellence in performance and Novartis values and behaviors
- Build and maintain a robust delivery leadership pipeline by identifying, mentoring, and developing high potential Program Delivery Leads and Associate Directors, supporting succession readiness and long-term stability of Clinical Data Delivery leadership
- Highlights the need for training programs and supports the establishment of these (technical, business, and soft skills) for clinical Data Delivery roles and ensure staff training is conducted and properly documented
- Provide oversight, governance and leadership to external partners and their team responsible for delivering on Novartis Portfolio.
- Leads and supports non-clinical/non-drug special projects and initiatives to drive functional excellence, productivity, and quality. Ensures high-quality communication and information flow of all deliverables to stakeholders, mitigates and manages risks. If required, deputizes for the Head of Data Delivery
Minimum Requirements:
- Proven leadership, collaboration and organizational skills with demonstrated ability to successfully achieve set goals and targets while ensuring high employee engagement, talent development and retention
- Excellent understanding of clinical trials methodology, Good Clinical Practice (GCP) and medical terminology
- Must be able to anticipate challenges and risks and proactively suggest/implement solutions
- Ability to work under pressure demonstrating agility through effective and innovative team leadership
- Excellent interpersonal skills and proven ability to operate effectively in a global environment. Ability to influence and communicate across sub-functions within CDO, line functions within GCO and with ex-GCO external stakeholders
- Ideally 12 years’ experience in Drug Development with at least 10 years in end-to-end clinical Data Management At least 8 years line management or leadership experience
- University or college degree in life science, computer science, pharmacy, nursing or equivalent relevant degree
Skills Desired
Clinical Trials, Data Architecture Development, Data Governance, Data Integration, Data Management, Data Quality, Data Science, Drug Development, Global Project Management, People Management