Serve as U.S. Medical Director for multiple 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 breast cancer 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, clinical sections of INDs, Investigator Brochures, CTAs, ISS s, ISE s, 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. 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.
Provide strategic input to individual clinical trial strategy and participate in strategy setting for clinical trial program.
Supervise and manage individuals on the US CDMA team as appropriate. 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).
Lead US cross functional Medical Product Teams and activities.
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.
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.
Position Requirements MD, board certified or board eligible in either Hematology or Oncology, or relevant Medical Specialty preferred. At least 4 years of experience in 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 with demonstrated record of scientific medical publications. Experience within breast cancer disease area highly 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 in the role. leadership are essential for success
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