Regional Medical Director, CART - Remote

Company: Novartis Farmac--utica
Location: Washington
Posted on: April 9, 2021

Job Description:

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 people's lives?

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 indication strategy.
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 functions.

--- 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 external meetings.

--- Ensure adherence to GCP/ICH and company Standard Operating Procedures (SOPs).

--- 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 requested

--- 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 role:

--- 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 pharmaceutical industry.

--- Scientific medical research experience in Hematology (or relevant specialty) with demonstrated record of scientific medical publications.

--- Successful interactions with Medical Experts and investigators with the ability to work across multiple functions is essential.

--- Demonstrated capability for strategic planning along with operations skill and experience related to clinical research involving both single and multiple centers.

Desirable requirements:

--- 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 experience.

--- 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 challenges.

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 potential.

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.

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