Clinical Development Medical Director - Basel, Schweiz - Novartis

Novartis

Geprüftes Unternehmen

Basel, Schweiz

vor 3 Wochen

Geschrieben von:

Lena Schneider

beBee Recruiter

Beschreibung

About the Role:

The Clinical Development Medical Director (CDMD) is responsible for leading the strategic planning and management of the assigned clinical program(s) from an end-to-end clinical development perspective.

As CDMD in Renal development, you will have oversight of the clinical development for the assigned programs and drive execution of the clinical development plan.

In addition, you will enable an empowered organization, which can navigate in a matrix environment and adjust quickly to business needs.

Your responsibilities:

Providing clinical leadership and strategic medical input for all clinical results in the assigned project or section of a clinical program
Leading development of clinical sections of trial and program level regulatory documents
Driving execution the assigned clinical program and/or clinical trial in partnership with global line functions, assigned Global Trial Directors (GTDs), and regional/country medical associates, where applicable
Supporting (Senior) 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 (SMT), supporting overall program safety reporting in collaboration with Patient Safety colleagues
Supporting the Clinical Development Head (CDH) by providing medical input into Clinical Development Plan (CDP), Integrated Development Plan (IDP) and Clinical Trial Protocol (CTP) reviews, and contributing to/driving development of disease clinical standards for new disease areas

Diversity & Inclusion / EEO:

We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._

Role Requirements:

What you bring to the role:

MD/medical degree is required in addition to sophisticated knowledge and clinical training in medical/scientific area; Clinical practice experience 4 years (including residency) and board certification or eligibility in Renal disease area preferred
Minimum of 7 years of proven experience in clinical research or drug development
Experience in an academic clinical research or industry environment spanning clinical activities in Phases I through IV required.
2 years of contribution to and accomplishment in all aspects of conducting clinical trials (e.g., planning, driving, reporting and publishing) in a global/matrix environment in pharmaceutical industry required.
Solid understanding of Renal disease area is required, with validated ability to interpret, discuss and present efficacy and safety data relating to clinical trial(s) and proven ability to understand and interpret basic and clinical scientific research reports
Demonstrated ability to establish effective scientific partnerships with key collaborators
Solid understanding of GCP, clinical trial design, statistics, and regulatory and clinical development processes
Previous global people management experience is preferred, though this may include management in a matrix environment.

Commitment to Diversity and Inclusion:

Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

Division

Development

Business Unit

CLINICAL DEVELOPMENT DEV
Location

Switzerland

Site

Basel

Company / Legal Entity

Novartis Pharma AG

Functional Area

Research & Development

Job Type

Full Time

Employment Type

Regular

Shift Work

No

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