Senior Clinical Development Medical Director

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

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 confidently 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.

Languages :

English

Novartis Compensation and Benefit Summary : The pay range for this position at commencement of employment is expected to be between : $ 257,600 - $386,400; however, while salary ranges are effective from 1 / 1 / 25 through 12 / 31 / 25, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills, and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and / or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an "at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department / team performance, and market factors.

EEO Statement :

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.

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 to perform the essential functions of a position, please send an e-mail to us.reasonableaccommodations@novartis.com or 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.

Salary Range

$236,600.00 - $439,400.00

Skills Desired

Budget Management, Clinical Research, Clinical Trials, Coaching, Cross-Functional Teams, Lifesciences, People Management, Risk Management, Risk Monitoring