About the Role
As the Clinical Development Medical Director (CDMD) Immunology you will lead clinical teams dedicated to autoimmune rheumatic disease development programs in indications such as Sjogren's disease or systemic lupus erythematosus, 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.
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 the Novartis Institute of 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.
This position will be located at the East Hanover, New Jersey site and will not have the ability to be located remotely. This position will require 3% travel as defined by the business (domestic and/ or international).
Diversity & Inclusion / EEO
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.
Role Requirements
What you'll bring to the role:
• 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. Specialty training in rheumatology is desired but not an absolute prerequisite.
• 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 & safety data relating to clinical trials.
• Understanding of GCP, clinical trial design, statistics, and regulatory and clinical development processes.
• Readiness to leverage scientific and clinical networks and establish scientific partnerships with key partners.
• Demonstrating ability to lead independent data monitoring committees and phase 2b/3 advisory boards
Desirable:
• Clinical practice experience 4+years (including residency in rheumatology) preferred.
• Previous global people management experience in clinical trial settings is preferred, though this may include management in a matrix environment.
You'll receive:
Competitive salary, annual bonus, pension scheme, share scheme, health insurance, 25 days annual leave, flexible working arrangements, subsidized dining facilities, employee recognition scheme and learning and development opportunities as well.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here:
https://talentnetwork.novartis.com/network
Why Novartis?
769 million lives were touched by Novartis medicines in 2020, and while we're proud of this, we know there is so much more we could do to help improve and extend people's lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world's toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do here at Novartis!
The pay range for this position at commencement of employment is expected to be between $257,600-386,400 a year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. 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.
Division
Development
Business Unit
IMMUNOLOGY DU
Location
USA
Site
East Hanover, NJ
Company / Legal Entity
Novartis Pharmaceuticals
Functional Area
Research & Development
Job Type
Full Time
Employment Type
Regular
Shift Work
No