Novartis Oncology is a leader in discovering, developing and marketing innovative drugs for patients with cancer and, due to rapid growth, we are seeking a board certified oncologist/hematologist with BMT experience and Clinical Research experience and interest to join our successful and growing US CDMA organization
The ideal candidate will provide strategic medical and scientific leadership in the CTL019 program, including new therapeutic areas. This position encompasses national studies and research projects. The candidate will also be involved in any US launch activities related to CTL019.
The successful candidate will direct US clinical activities including:
Serve as U.S. Senior Medical Director for global clinical development trials and/or U.S. Medical Affairs Trials (including both Novartis Sponsored and Investigator Initiated) in the therapeutic area of CART.
Manage a team of 2-4 MDs and 4 clinical scientists
Design and optimize clinical trial design and ensure clinical trials meet ethical and regulatory standards;
o Develop US specific clinical research plan for CTL019 in the areas of malignant hematology (eg. Pediatric ALL and DLBCL) that compliments global plan;
o Medical support regarding the execution of launches in the US for CTL019;
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, responses to clinical questions from Health Authorities or IRBs related to sponsored studies within EDSI, and other documents for external or internal audiences related to EDSI sponsored studies.
US representative on CART GPT;
US Medical expert for review and feedback to Global Protocols and Global Development Plans.
Develop strategy for US CTL019 studies including exploratory indications and integrate US plan with overall Global strategy. Oversee the review and approval of IIT concepts. Oversight during the conduct of trials including safety monitoring. Review of interim and final publication, manuscripts, or abstracts.
Supervise and manage individuals on the EDSI team as appropriate. Lead the Clinical Team, including interactions with Safety, HEOR, Marketing, Regulatory, Research, and other functions.
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).
Assist in the development and appropriate spending of US CART clinical budget.
Extensive interactions with academic thought leaders to optimize clinical trial strategies.
Extensive interactions with other functional teams including HEOR, Medical Information, Scientific Communication, Commercial, Regulatory and others, to refine compound strategy and projects.
Coach and train internal colleagues as requested.
Medical liaison on CTL019 with US commercial
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 any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
MD, or equivalent required. Board Certified in Hematology required, with clinical experience in stem cell transplantation preferred.
At least 5 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 and or transplantation (or relevant specialty) with demonstrated record of scientific medical publications, preferred.
Experience leading the design, conduct, analysis and reporting of clinical studies is strongly preferred.
Superior leadership, networking, collaboration and communication skills.
Successful interactions with Medical Experts and investigators.
Demonstrated the capability for strategic planning along with operations skill and experience related to clinical research involving both single and multiple centers.
Ability to work across multiple functions is essential.
Effective oral and written communications skills and strong leadership are essential for success in the role.
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