20 publicaciones de empleo destacadas de community associate en catalunya (¡Están contratando!)

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Clinical Development Medical Director

Novartis -
Barcelona, Barcelona provincia

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Detalles del empleo

Jornada completa

Cualificaciones

Investigación clínica
Investigación
Liderazgo

Descripción completa del empleo

Summary

The Senior Clinical Development Medical Director (Sr CDMD) will lead the end-to-end strategy and execution of assigned renal clinical development program(s) across the full Research, Development and Commercial (RDC) continuum; from early development through pivotal/registrational phases. This is a key leadership role requiring hands-on experience in both early and late phase renal drug development. With the ability to translate emerging data into a clear clinical and regulatory path, drive delivery in a global matrix, and ensure rigorous benefit–risk decision making throughout the program lifecycle.

About the Role

Major accountabilities:

Your responsibilities will include, but are not limited to:

Providing clinical leadership and strategic medical input for all clinical deliverables in the assigned project or section of a clinical program
Leading development of clinical sections of trial and program level regulatory documents
Driving execution of 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
As a medical expert, supporting the (Sr.) GPCH or CDH in interactions with external and internal stakeholders and decision boards
May work with BR (Biomedical Research/ Translational Medical Sciences) to drive transition of pre-PoC (Proof of Concept) projects to DDP (Development Decision Point) and with BD&L (Business Development & Licensing) 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 advanced knowledge and clinical training in medical/scientific area; Clinical practice experience 4 years (including residency) and board certification or eligibility in disease area preferred
Minimum of 10 years of experience in clinical research or drug development
Experience in an academic clinical research or industry environment spanning clinical activities in Phases I through IV is required.
Working knowledge of renal disease area is required, with proven 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 stakeholders
Working knowledge 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.

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

Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: Novartis Life Handbook

Accessibility and accommodation Novartis is committed to working with and providing reasonable accommodation to all individuals.

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Benefits and Rewards: Learn about all the ways we’ll help you thrive personally and professionally.
Read our handbook (PDF 30 MB)

Division

Development

Business Unit

Development

Location

Spain

Site

Barcelona Gran Vía

Company / Legal Entity

ES06 (FCRS = ES006) Novartis Farmacéutica, S.A.

Functional Area

Research & Development

Job Type

Full time

Employment Type

Regular

Shift Work

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