Job Description Summary
Posting Title: Study Director Community Lead
On site East Hanover, NJ
About the role
Oversee the execution and delivery of a portfolio of GCO supported clinical studies for Novartis, of diverse complexities and priorities, in accordance with the Clinical Development Plan (CDP) and Operational Execution Plan (OEP). The assigned portfolio is a set of clinical trials of similar types defining a Study Leadership community.
Provide developmental support and guidance to Study Leaders within the community in navigating stakeholders and operational aspects of clinical trials in accordance with Standard Operating Procedures (SOPs), Good Clinical Practices (GCP), and specific country regulations. This covers all operational aspects of a clinical trial.
Responsible to improve and innovate the operational execution of the type of trials within the assigned community. Promotes operational excellence and knowledge sharing across studies. Fosters an empowered, psychologically safe organization that can navigate a matrix environment, learns, and adjusts quickly to changing conditions and business needs.
Oversees people allocation (resource management) within assigned community. The Study Director Community Lead may act as a Study Director, being the leader of the cross-functional clinical trial team (CTT), guiding planning and management of the assigned clinical study/studies end-to-end to achieve Global Program Team (GPT), Global Clinical Team (GCT), and GCO objectives. Accountable for proactive, iterative operational planning with effective contingencies and embedded risk management mindset in the CTT.
Your Key Responsibilities:
- 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:
- Establish and manage a community of Study Leaders that is self-organized, disciplined and able to independently set community objectives.
- Constantly improve and innovate in the operational execution of the type of trials within the assigned community.
- 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.
- Hiring, onboarding, development, and retention of Study Leaders.
- 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.
- 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).
- Partner with Study Leaders to foster their growth in leadership through role modeling, mentoring and coaching; refrain from command-and-control leadership.
Role 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 and of high priority for Novartis.
- ≥ 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 and Novartis standards.
- ≥ 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.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? Learn more.
Salary Range: $201,600 - $302,400/year
Skills Desired: Agility, Budget Management, Clinical Monitoring, Clinical Research, Clinical Trials, Lifesciences, Resource Management (Organizational)
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