Clin Ops Prog Dir (Feasibility)

Summary

Onsite, East Hanover, NJ But a Distant Work Arrangement could be considered for the right candidate About the role: The Clinical Operational Program Director (COPD) 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 Global Clinical Operations Program Management team this leadership role will provide oversight and ensure data driven feasibility outputs alignment with the overarching strategy and GCO operational position.

About the Role

Your Key Responsibilities:

• Lead and conduct the end-to-end feasibility process starting from early viability assessments as well as pre-IMB and trial feasibilities and for developing strategic allocation, site selection and recruitment plans scenarios for the assigned programs and trials

• Serve 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.

• Identify and mitigate events in the indication landscape that represent operational risks for the execution of clinical trials. Lead integration of regional and local indication strategies within global execution plans

• Partner closely with the country feasibility team to align on the end-to-end quality of feasibility product

• Manage 4-6 associates with the responsibility to apply people management processes and act as coach and mentor for the associates

• Will also be crucial contributor to our Operational Execution Plan. This would include:

a. Create and maintain of patient enrolment forecast, at study levels

b. Ensure 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.

c. Improve and develops tools and processes for early viability assessments, feasibilities, recruitment projections, etc.

d. Act as Practice Network Leader within the Clinical Operational Program Management organization that owns, develops, and disseminates processes, best-practices (inclusive of timely BD&L assessments), and new technologies related to early viability, feasibility trial allocation and related risk management

Minimum Requirements:

Bachelor's degree (or equivalent) in life science/healthcare

• 7 years of pharmaceutical clinical drug development experience, with 3 years in planning/execution in global clinical trials.

• Demonstrated profound experience in data driven feasibility for global clinical trials.

• Strong understanding of all aspects of clinical drug development with emphasis on clinical trial design, trial execution, and strong knowledge about the feasibility and allocation process of a program and/or study.

• Possess strong, resourceful research skills to locate unusual information and have capacity to develop a deep domain specific knowledge base.

• Understand the Clinical Trial matrixed process from research through post marketing phase IV, health authority guidelines, country challenges and sources for therapeutic area data.

• Demonstrated ability to collaborate across partner functions in a matrix environment, without direct reports, but able to coordinate the activities of others.

• Proven success in identifying, proactively flagging, and resolving risks; experience with strategic scenario planning

Why Novartis: Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world.

How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions.

Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture

You'll receive:

You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook.

https://www.novartis.com/careers/benefits-rewards

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.

Accessibility and 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 in order to perform the essential functions of a position, please send an e-mail to tas.nacomms@novartis.com 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.

Novartis Compensation and Benefit Summary: The pay range for this position at commencement of employment is expected to be between $201,000 - $302,000/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 performance, and market factors.

Join our Novartis Network: If this role is not for you, but you wish to stay connected to learn more about Novartis and our career opportunities,

join the Novartis Network here: https://talentnetworork.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?