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Clinical Development Medical Director
3 months ago
**Summary**:
As the Clinical Development Medical Director (CDMD) Immunology you will lead clinical teams dedicated to inflammatory skin disease development programs in indications such as atopic dermatitis or vitiligo, 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.
**About the Role**:
**Major accountabilities**:
- Providing clinical leadership and strategic medical input for all clinical deliverables in the assigned project or section of a clinical programCollaborate with the Novartis Biomedical Research/Translational Medical Sciences to facilitate the progression of pre-proof-of-concept (PoC) projects towards a development decision point (DDP) and liaise with the Business Development & Licensing (BD&L) group, engaging in tasks such as target identification and due diligence assessments to evaluate external opportunities.
- 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 (GPCH) 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 (CDH) 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
**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. Specialty training in dermatology is desired but not an absolute prerequisite.
- 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 dermatology) preferred.
- Previous global people management experience in clinical trial settings is preferred, though this may include management in a matrix environment.
Division
Development
Business Unit
Pharmaceuticals
Location
USA
Site
East Hanover
Company / Legal Entity
U014 (FCRS = US014) Novartis Pharmaceuticals Corporation
Alternative Location 1
Ireland
Alternative Location 2
United Kingdom
Alternative Location 3
Switzerland
Functional Area
Research & Development
Job Type
Full time
Employment Type
Regular
Shift Work
No
