Job Description Summary
As the Clinical Development Medical Director (CDMD) Immunology you will lead clinical teams dedicated to autoimmune rheumatic disease development programs in indications of lupus, including both systemic lupus erythematosus and lupus nephritis, through all study phases from inception/design to database lock and read-out. Core responsibilities include planning and management of the assigned clinical projects(s) from an end-to-end clinical development perspective. Together with your team, you will drive execution of the clinical development plan. You will harness the strengths of a diverse team and create a collaborative and inclusive work environment You are eager to empower your team members, in a complex matrix environment and adjust quickly to business needs.
Job Description
Your key responsibilities:
Providing clinical leadership and strategic medical input for all clinical deliverables in the assigned project or section of a clinical program
Lead development of clinical sections of trial and program level regulatory documents
Drive execution of the program and/or clinical trial in partnership with global line functions, assigned Global Trial Directors, and regional/country medical associates
Support the Global Program Clinical Head in ensuring overall safety of the molecule for the assigned section, and may act as a core member of the Safety Management Team, supporting overall program safety reporting in collaboration with Patient Safety colleagues
Support the Clinical Development Head by providing medical input into the Clinical Development Plan, Integrated Development Plan and Clinical Trial Protocol reviews. and contributing to development of disease clinical standards for new disease areas
As a medical specialist, supporting the GPCH or CDH in interactions with external and internal partners and decision boards
May work with Novartis Biomedical Research/ Translational Medical Sciences to drive transition of pre-PoC projects to DDP and with BD&L including target identification and due diligences together with other medical matters, as needed
Minimum Requirements:
MD or equivalent medical degree is required, in addition to a proven track record of clinical experience in and scientific contributions to your field of expertise.
Training or working experience in one or more of the following:
- Rheumatology or clinical immunology
- Lupus clinical trial experience (systemic lupus erythematosus and/or lupus nephritis)
- B cell-depleting biologics
3+ years minimum in clinical research or drug development in immunology/inflammation
Working knowledge in the area of Immunology and Inflammation with ability to interpret, discuss and present efficacy (clinical, biomarker) and safety data relating to clinical trials
Understanding of GCP, clinical trial design, statistics, and regulatory and clinical development processes
Availability of, and readiness to leverage scientific and clinical networks to establish scientific partnerships with key collaborators
Ability to expertly lead independent data monitoring committees and phase 2b/3 advisory boards
Desirable:
Clinical practice experience 4+years (including residency in rheumatology or clinical immunology)
Previous global people management experience in clinical trial settings is preferred, though this may include management in a matrix environment.
EEO Statement:
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 other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.
Accessibility and reasonable accommodations
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to tas.nacomms@novartis.com call +1 (877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
https://www.novartis.com/careers/careers-research/notice-all-applicants-us-job-openings
Salary Range
$257,600.00 - $386,400.00
Skills Desired
Budget Management, Clinical Research, Clinical Trials, Coaching, Cross-Functional Teams, Lifesciences, People Management, Risk Management, Risk Monitoring
