Regional Medical Director, CART - Remote
Company: Novartis Farmac--utica
Posted on: April 9, 2021
Regional Medical Director, CART - Remote Job ID 316164BR
Position Title Regional Medical Director, CART - Remote Job
Description 769 million patients were impacted by Novartis products
in 2020. And while we're proud of that fact, in this world of
digital and technological transformation, we must also ask
ourselves this: how can we continue to improve and extend even more
The U.S. Regional Medical Director, CART will partner with the
global clinical development teams on US site participation and/or
lead U.S. Medical Affairs Trials (including phase I-IV, Expanded
Access, Investigator Initiated, registries and Compassionate Use).
The U.S. Regional Medical Director, CART will work with the
oncology therapeutic area Global and U.S. Clinical Team Members,
Clinical Operations, Scientific Operations, Regulatory Affairs,
Drug Supply, Data Management, Finance, Quality, Compliance, and
other relevant functional areas.
Your responsibilities include, but are not limited to:
--- Design and optimize clinical trial design and ensure clinical
trials meet ethical and regulatory standards including:
o Write and review protocols that are in-line with the overall
o Conduct medical review and interpretation of efficacy and safety
data from clinical trials.
--- Responsible for the quality, coordination, medical accuracy,
and timeliness of clinical study reports, clinical expert reports,
and label reviews.
--- Review and provide US feedback to Global Protocols and Global
Development Plans. Develop strategy for US Medical Affairs
including exploratory indications and integrate US plan with
overall Global Medical Affairs strategy.
--- Supervise the approval process for IIT concepts. Oversight
during the conduct of trials including safety monitoring. Review of
interim and final publication, manuscripts, or abstracts.
--- Provide strategic input or develop strategy for US clinical
trial programs. May also evaluate global strategy for the clinical
trial programs, supervise and lead individuals on the US CDMA team
as appropriate and lead the Clinical Team, including interactions
with Safety, HEOR, Marketing, Regulatory, Research, and other
--- Work with Clinical Team and other functions to prepare
abstracts, manuscripts and presentations for external meetings as
well as author clinical sections of regulatory documents (i.e. IB,
IND sections), for Company Sponsored project. Review and approve
abstracts publications & manuscripts for Investigator Initiated
Trials to ensure clinical accuracy and appropriate safety review.
Present and discuss data and findings at relevant internal and
--- Ensure adherence to GCP/ICH and company Standard Operating
--- Where applicable, may lead disease area teams to:
o Ensure delivery of US medical tactical plan and development
activities across all of a compound's related to the disease area,
cost, time and quality.
o Collaborate and work with other USOM line functions for data gaps
analysis, data generation activities, strategic congress
management, strategic trial management, external partner management
and launch readiness plans.
--- Support and participate in FDA meetings including
presentations, briefing books, and responding to FDA inquiries as
needed. Assist in the development and appropriate spending of
clinical budget and coach and train internal colleagues as
--- Extensive interactions with academic thought leaders to
optimize clinical trial strategies, as well as extensive
interactions with other functional teams including HEOR, Medical
Information, Scientific Communication, Commercial, Regulatory and
others, to refine compound strategy and projects.
EEO Statement 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
--- MD required with Board Certified or board eligible in either
Hematology or Oncology, or relevant Medical Specialty.
--- A minimum 3+ years of experience in Hematology clinical
research in the pharmaceutical industry OR experience in clinical
research or medical affairs is preferable or a combination of
experience in academic medicine with clinical research and or
clinical development experience in collaboration with the
--- Scientific medical research experience in Hematology (or
relevant specialty) with demonstrated record of scientific medical
--- Successful interactions with Medical Experts and investigators
with the ability to work across multiple functions is
--- Demonstrated capability for strategic planning along with
operations skill and experience related to clinical research
involving both single and multiple centers.
--- Experience leading the design, conduct, analysis and reporting
of clinical studies is strongly preferred.
--- Superior leadership, networking and collaboration skills,
coupled with effective oral and written communications skills and
strong leadership are strongly preferred and essential for success
in the role.
--- Position will be filled at level commensurate with
--- This position can be based remotely anywhere in the U.S. (there
may be some exceptions based on legal entity registration). Please
note that this role would not provide relocation as a result. The
expectation of working hours and travel (domestic and/or
international) will be defined by the hiring manager.
We believe the answers are found when curious, courageous and
collaborative people like you are brought together in an inspiring
environment. Where you're given opportunities to explore the power
of digital and data. Where you're empowered to risk failure by
taking smart risks, and where you're surrounded by people who share
your determination to tackle the world's toughest medical
Imagine what you could do at Novartis!
Commitment to Diversity & Inclusion:
Novartis embraces diversity, equal opportunity and inclusion. 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
Join our Novartis Network: If this role is not suitable to your
experience or career goals but you wish to stay connected to learn
more about Novartis and our career opportunities, join the Novartis
Network here: https://talentnetwork.novartis.com/network Division
ONCOLOGY Business Unit ONCOLOGY BU Location USA Site East Hanover,
NJ Company/Legal Entity Novartis Pharmaceuticals This site is
intended for a global audience.
Keywords: Novartis Farmac--utica, Washington DC , Regional Medical Director, CART - Remote, Hospitality & Tourism , Washington, DC
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