Clinical Development Medical Director

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.

• 2+ years minimum in clinical research or drug development in immunology/inflammation with a preference for candidates with industry-based experience in dermatology clinical development• 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.