Key responsibilities:

Study Director Community Lead

• Leader of a Study Leadership community. This includes people management responsibility within the Study Leadership organization
• Oversees the execution and delivery of a portfolio of GCO supported clinical studies for Novartis of diverse complexities and priorities within the assigned community.
• As a community lead:
• a) Establish and manage a community of Study Leaders that is self-organized, disciplined and able to independently set community objectives.
• b) Constantly improve and innovate in the operational execution of the type of trials within the assigned community.
• c) Together with the Head Study Leadership and the SSO S&O office, performs ongoing assessment and promotes efficient allocation of Study Leaders to ensure balanced workload in line with SSO priorities
• d) Hiring, onboarding, development, and retention of Study Leaders
• e) Coaches Study Leaders to have the required level of capabilities, including understanding of agile principles and therapeutic area knowledge, to successfully deliver timely, high-quality studies that meet business outcomes
• f) Apply and encourage an agile mindset, values, and principles; be an ambassador and a catalyst for the established ways of working (with focus on CTT)
• g) Partner with Study Leaders to foster their growth in leadership through role modeling, mentoring and coaching; refrain from command-and-control leadership

Co-leader of the Clinical Trial Team

• Leads independently the Clinical Trial Team (CTT) together with the CSL in collaboration with the Clinical Operations Program Head (COPH), delivery of multiple complex global studies and promotes learning, sharing, consistent performance, and operational excellence through an agile mindset, agile principles, and a team of team’s model
• Acts as the CTT product co-owner with duties and responsibilities for delivery of the operational strategy per established ways of working
• Guides planning and decision making at the study level and delivers assigned clinical study/studies per the Operational Execution Plan (OEP) and clinical study protocol
• Fosters an agile culture within assigned studies to achieve sprint goals and cycles, maximizing collaboration and minimizing dependencies in order to achieve long-term business impact
• In collaboration with regulatory writing and clinical development, promotes operational excellence in the development of global clinical study protocol(s), by translating the approved study concept sheet(s) into efficient, high quality, executable clinical protocols, and study-related documents
• Create effective CTT dynamics and achieve on performance, prioritization, and communication in close collaboration with CTT sub-team leaders
• Proactive risk management and inspection readiness
• Responsible for developing clinical study timelines in collaboration with the Clinical Operations Program Head (COPH), and overseeing assigned study budgets
• Ensures systems are maintained with up-to-date study status, risks, and issues
• Fosters a close working relationship with the SSO Clinical Program Managers (CPMs) to strengthen the relationship between the global and local teams
• Oversees study recruitment and responsible for activating mitigation strategies in collaboration with the SSO Clinical Program Managers (CPMs)
• Fosters a close working relationship with the Vendor Partnerships & Governance (VPG) Trial Vendor Managers (TVMs) to strengthen the relationship between the vendors and CTT to deliver on clinical study objectives
• Fosters a close working relationship with the Clinical Data Operations (CDO) Trial Data Scientist (TDS) to deliver on clinical study objectives
• Ensures proper handling of all study close out activities including, but not limited to, site close out, final drug accountability, and audit readiness of Trial Master File documentation
• Promotes operational excellence and contributes to the development of Clinical Study Reports; reporting of clinical study results, and internal/external publications, when appropriate
• Partners and collaborates with Program Strategy & Planning (PSP)/Clinical Operations Program Head (COPH) to deliver clinical studies in alignment with program strategy
• Achieves excellence in study operations and management through process improvement in collaboration with the Head Study Leadership or the Study Leader Community Lead/Host (as applicable) and GCO Process, Training, and Compliance (PTC)
• May deputize for the COPH as a leader and spokesperson for the CTT at Novartis internal meetings

CTT coaching and resource management

• Partners and collaborates with functional line leadership to ensure optimal people staffing of the study team
• Build high-performing teams and creates an empowered, psychologically safe culture to foster high performance in a matrix environment
• Serves as the single point of contact

Essential requirements:

• Bachelor’s degree in life sciences/healthcare (or clinically relevant degree) is required. Advanced degree is strongly preferred.
• ≥ 8 years of recent involvement in clinical research or drug development in an academic or industry environment spanning clinical activities in Phases I through IV studies of medium to highly complexity
• ≥ 5 years of recent contribution to and accomplishment in all aspects of conducting clinical studies of medium to highly complexity and of high priority for novartis (e.g., planning, executing, reporting, and publishing) in a global/matrix environment in pharmaceutical industry or a contract research organization, including expert knowledge of international standards (GCP/ICH), health authorities (FDA/EMA), local/National Health Authorities regulations
• ≥5 years recent people management in a complex matrix environment. Experience in managing people globally strongly preferred
• Management of virtual teams. Proven ability and strong experience leading teams and building capabilities
• Experience in developing effective working relationships with internal and external stakeholders

Desirable requirements:

• Excellent communicator and presenter (oral and written); ability to communicate at all levels
• Outstanding organization and prioritization
• Excellent negotiation and conflict resolution skills and enterprise mindset
• Strong project management skills and demonstrated ability to meet timelines
• Proven track record in study operations process improvement(s)
• Superior strategic thinking with strong analytical and problem-solving skills
• Extensive knowledge of appropriate therapeutic area preferred