Serve as US Medical Director for multiple global clinical development trials and/or US Medical Affairs Trials (phase I-IV, Expanded Access Programs, 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.
Participate in designing and optimizing clinical trials and ensure they meet ethical and regulatory standards
Responsible for the quality, coordination, medical accuracy, and timeliness of various medical documents (clinical study reports, clinical sections of INDs, IBs, clinical expert reports, etc)
Review and provide US feedback to Global Protocols and Global Development Plans.
Develop strategy for US Medical Affairs and integrate US plan with overall Global Medical Affairs strategy.
Oversee the review and approval of IIT concepts.
Lead the Clinical Team, including interactions with Safety, HEOR, Marketing, Regulatory, Research, and other functions.
Work with Clinical Team and other functions to prepare scientific communications for external meetings as well as author clinical sections of regulatory documents (i.e. IB, IND sections), for US Medical Affairs trials.
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.
Foster interactions with academic thought leaders to optimize clinical trial strategies.
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, required. Board Certified or Board Eligible in either Hematology or Oncology, or relevant Medical Specialty desirable.
At least 6 years of experience in hematology/oncology clinical research in the pharmaceutical industry OR/AND experience in clinical research is preferable
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.
Moderate travel required (mostly within US)
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