Clinical Operations Program Associate Director-Global Feasibility Role

Job Description

100,000+ That’s how many patients participate in our clinical trials at any given time. GCO is Novartis’ powerhouse of Global Clinical Operations, redesigned to enable faster trial recruitment and enhanced trial delivery resulting in more timely access for patients to potential novel treatments. Every day, we are the link between science and medicine - imagine the impact you could have as a Clinical Operations Program Associate Director!
#GCO

The Clinical Operations Program Associate Director (COPaD) is accountable for the oversight, coordination and development of early viability assessments, global feasibility assessments (pre-IMB and trial feasibility), recruitment projections and allocation strategies for the assigned trials and programs. As a key member of the GCO sub-team, the COPaD will provide precise oversight and ensure alignment with the overarching strategy and GCO operational position adding directly into the feasibility strategies.

The COPaD scope of activities include pre-IMB project feasibility and/or early viability assessment, trial feasibility assessment, validation and refinement of trial allocation strategy, including scenario planning and risk management, and any re-feasibility assessments, as applicable. Drives operational excellence through overall project milestone management and system requirements, process improvement and knowledge sharing across clinical indication(s)/program(s) within Development Unit. Navigates in a matrix environment and adjusts quickly to business needs.

Leads analyses of external and internal data to validate and refine strategic allocation of assigned trials and programs enabling accurate overall decision making by Clinical Operations Program Head (COPH) and GCO sub-team.

Partners with OPH and is a key member of the GCO sub-team ensuring delivery of the Operational Execution Plan (OEP) by applying agile and product-oriented ways of working. Displays full allegiance to the COPH and GCO sub-team and is accountable for high quality and timely contributions to the OEP.

Key partner to the Feasibility Managers and CRMAs to ensure overall quality and delivery of feasibility assessments from initial site identification until final site allocation

This role will be part of the GCO Selection University approach. If you wish to apply for any more Selection University positions, please make sure you do so within the same day to ensure your applications can be reviewed jointly by the selection panel.

Your key responsibilities:
•Accountable for leading and conducting the end-to-end feasibility process.
•As part of the GCO sub-team, remains as the point of contact for assigned program and trial feasibilities, leading the multidisciplinary feasibility teams to develop, validate and refine allocation strategy, including timelines, scenarios, and risk mitigation plans. Identifies and resolves events in the indication landscape that represent operational risks for the execution of clinical trials within the given indication/program.
•Partners closely with the country feasibility team to align on the end-to-end quality of feasibility product
•Key contributor to the Operational Execution Plan:
•Responsible for the creation and maintenance of patient enrolment forecast, at study levels
•Ensures alignment of feasibility and allocation strategy and seamless start up planning with COPH, Study Start-Up Lead and feasibility teams, in collaboration with teams/associates responsible for regional feasibility.
•Improves and develops tools and processes for early viability assessments, feasibilities, recruitment projections, etc.
•May participate in cross-functional strategic initiatives

Diversity & Inclusion / EEO

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.

Minimum Requirements

What you'll bring to the role:
• ≥ 5 years of pharmaceutical clinical drug development experience recommended
• Strong understanding of all aspects of clinical drug development with particular emphasis on clinical trial design, trial execution, and strong knowledge about the feasibility and allocation process of a program and/or study.
• Understand the Clinical Trial matrixed process from research through post marketing phase IV, health authority guidelines.

Why 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!

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network

The ideal location for this role is East Hanover, but employees with an existing Distant Working Arrangement (DWA) or remote designation who have been impacted through restructuring will be considered for a DWA. Please note that this role would not provide relocation as a result. All home office expenses and any travel/lodging to a primary work site for periodic live meetings will be at the employee’s expense. The expectation of working hours and travel (domestic and/or international) will be defined by the hiring manager.

US Accessibility and Reasonable Accommodations:
Individuals in need of a reasonable accommodation due to a medical condition or disability 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.

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

The pay range for this position at commencement of employment is expected to be between $151,200 and $226,800; however, while salary ranges are effective from 1/1/23 through 12/31/23, 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.