Novartis Pharmaceuticals is looking for a Medical Director of Non-Malignant Hematology to join our team. This role will develop and execute strategic Global Medical Affairs programs, with a focus on innovative evidence generation and launch readiness. You will provide medical expertise for strategy development, planning, and scientific engagement.
What You'll Do
- Serve as US Medical Director for multiple global clinical development trials and/or US Medical Affairs Trials.
- Interface with oncology therapeutic area Global and US Clinical Team Members and other relevant functional areas.
- Design and optimize clinical trial design and ensure clinical trials meet ethical and regulatory standards.
- Write and review protocols that are in-line with the overall indication strategy.
- Conduct medical review and interpretation of efficacy and safety data from clinical trials.
- Ensure the quality, coordination, and medical accuracy of clinical study reports, 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.
- Oversee the review and approval of Investigator Initiated Trial concepts.
- Provide oversight during the conduct of trials including safety monitoring.
- Review interim and final publications, manuscripts, or abstracts.
- Provide strategic input or develop strategy for US clinical trial programs.
- May supervise and manage individuals on the US disease team.
- Lead the Clinical Team, including interactions with Safety, HEOR, Marketing, Regulatory, and Research.
- Work with teams to prepare abstracts, manuscripts, and presentations for external meetings.
- Review and approve abstracts and publications for Investigator Initiated Trials.
- Present and discuss data and findings at relevant internal and external meetings.
- Ensure adherence to GCP/ICH and company Standard Operating Procedures.
- Collaborate with other functions for data gaps analysis, data generation, and launch readiness plans.
- Support and participate in FDA meetings including presentations and briefing books.
- Assist in the development and appropriate spending of clinical budget.
- Conduct extensive interactions with academic thought leaders to optimize clinical trial strategies.
- Collaborate with other functional teams including HEOR, Medical Information, and Commercial.
- Coach and train internal colleagues as requested.
What We're Looking For
- MD, PhD, PharmD, or equivalent required.
- If MD, Board Certified or board eligible in either Hematology or Oncology, or relevant Medical Specialty.
- At least 3-10 years of experience in Hematology/Oncology clinical research in the pharmaceutical industry, or relevant academic/clinical development experience.
- Scientific medical research experience in Oncology and/or Hematology with a demonstrated record of scientific medical publications.
- Superior leadership, networking, collaboration and communication skills.
- Experience with successful interactions with Medical Experts and investigators.
- Demonstrated capability for strategic planning along with operational skill in clinical research.
- Ability to work across multiple functions.
- Effective oral and written communications skills and strong leadership.
Nice to Have
- Experience leading the design, conduct, analysis and reporting of clinical studies.
Benefits & Compensation
- Compensation range: $204,400 - $379,600/year for the Director level.
- Full range of medical, financial, and/or other benefits.
- 401(k) eligibility.
- Various paid time off benefits, such as vacation, sick time, and parental leave.
- Sign-on bonus.
- Restricted stock units.
- Discretionary awards.
Work Mode
This position operates on a global work mode.
The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.
