• Serve as U.S. Medical Director for global clinical development trials and/or U.S. Medical Affairs Trials (including phase I-IV, Expanded Access, Investigator Initiated, registries and Compassionate Use). Interface 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.
• 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, 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.
• Responsible for creation, coordination and review of abstracts and manuscripts related to EDSI sponsored studies.
• Review and provide US feedback to Global Protocols and Global Development Plans.
• Develop strategy for US EDSI studies including exploratory indications and integrate US plan with overall Global TCO 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.
• Develop strategy for clinical trial programs.
• 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).
• Support US cross functional iDOCS teams and activities.
• Assist in the development and appropriate spending of 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.
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, PhD Pharm D, or equivalent required. If MD, Board Certified or board eligible in either Hematology or Oncology. If PhD or Pharm D, strong background involving immuno-oncology or molecular biology (including basic and/or clinical experience).
• At least 6 years of experience in Hematology/Oncology 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 Oncology and or Hematology (or relevant specialty) with demonstrated record of scientific medical publications.
• 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.