Summary
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 a 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:
1. Leader of a Study Leadership community. This includes people management responsibility within the Study Leadership organization
2. Oversees the execution and delivery of a portfolio of GCO supported clinical studies for Novartis of diverse complexities and priorities within the assigned community.
3. 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
About the Role
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? https://www.novartis.com/about/strategy/people-and-culture
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
Commitment to Diversity & Inclusion: The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.
Novartis Compensation and Benefit Summary: The pay range for this position at commencement of employment is expected to be between $201,600 - $302,400/year; however, while salary ranges are effective from 1/1/24 through 12/31/24, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills, and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about
suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
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? https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
EEO Statement:
The Novartis Group of Companies are Equal Opportunity Employers who are focused on building and advancing a culture of inclusion that values and celebrates individual differences, uniqueness, backgrounds and perspectives. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to fostering a diverse and inclusive workplace that reflects the world around us and connects us to the patients, customers and communities we serve.
Accessibility & Reasonable Accommodations
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [email protected] or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
