Senior Medical Director, Early R&i - Barcelona, España - AstraZeneca

AstraZeneca

Empresa verificada

Barcelona, España

hace 3 semanas

Publicado por:

Isabel García

beBee Recruiter

Descripción

Job Title - Senior Medical Director, Early Clinical Research, Rheumatology/Clinical Immunology:

Location - Office based role in Gaithersburg MD OR Boston MA OR Barcelona Spain OR Gothenburg Sweden - (_all locations have hybrid model of in office + remote work)_**:

Here at AstraZeneca (AZ) you will have the opportunity to make a significant difference to patients' lives around the globe.

With science at its heart, this is the place where breakthroughs born in the lab become transformative medicines for the world's most complex diseases and answer unmet medical needs by pioneering the next wave of science, focusing on outcomes and shaping the patient ecosystem.

The Role:

AZ is seeking to appoint a Senior Medical Director in Early Clinical Development for one or more immunology programs, including the development of novel biologics, small molecules and / or cell therapies for autoimmune and/or inflammatory diseases.

This is an excellent opportunity for an experienced and motivated drug developer to shape and deliver the AZ Immunology pipeline.

The Senior Medical Director will provide medical and scientific input to preclinical and clinical stage assets focused on Immunology / Rheumatology / Inflammatory Bowel Disease.

Experience in early-stage drug development in non-oncology indications is a must.

Drug development experience in immunology indications strongly preferred (eg trials in diseases such as systemic lupus erythematosus (SLE), rheumatoid arthritis (RA) and/or inflammatory bowel disease).

Responsibilities:

Responsible for the design, delivery and interpretation of clinical studies from firstin human through Ph2b, ensuring compliance with GCP and ethical / scientific integrity of studies
Lead ongoing monitoring of clinical data to ensure quality and safety, including SAE/SUSAR/protocol deviations and periodic review of emerging safety data by SRC/DMCs, and support of investigational sites on protocol related matters and investigation of unexpected trends in data
Lead clinical development strategy from early target identification through Phase 2b (with senior support as necessary) and secure crossfunctional alignment across wider AZ organization
Provide clinical development /disease expertise to Research, Translational Medicine, Early and Latestage Clinical Development and Commercial colleagues as part of a cross functional teams
Closely follow medical developments within the autoimmune / inflammatory diseases and disseminate new information within the clinical development team to transform trends and emerging data into agile and innovative clinical plans
Represent Early Clinical Development at internal governance interactions and with external collaborators, including Investigators, key opinion leaders, and patient advocacy groups (eg regulatory, site, CROs and KEEs)
Medical lead for regulatory communications and preparation of higher level study documents (protocols, briefing books, ICFs, PIPs, SAPs)
Support qualification of pharmacodynamic/disease markers for early assessment of efficacy
As available, provide clinical strategic input to inlicensing opportunities

Education, Experience and Skills Required:

Terminal degree in relevant scientific discipline (
MD (or international equivalent) or PhD) is required
Subject matter authority in rheumatology, immunology and /or inflammatory bowel disease from drug development experience in nononcology indications
Must have significant experience of more than 8 years in clinical development, including handson experience in early development areas of design, delivery and interpretation of multiple Ph1 / Ph2 studies
Significant experience in the authoring or relevant regulatory documents, including INDs, protocols, ICFs, PIPs, briefing books as well authoring responses to HAs / ECs and site queries
Thorough understanding of the entire drug development process, including clinical study design and execution, a thorough understanding of clinical research methodology and biostatistics principles to facilitate innovative and efficient clinical trial design, development plans with clear datadriven decision framework
Thorough command of FDA, MHRA and ICH GCP guidelines to ensure the appropriate conduct of global clinical studies
Attention to detail, internal motivation to generate highquality work, a sense of passion and urgency to achieve team and program goals
Demonstrated experience leading sophisticated projects and working collaboratively with multiple partners regarding new strategies to ensure best approach
Demonstrated track record in delivering results and in expressing outstanding verbal and written communication skills
Excellent analytical, problem solving and strategic planning skills

Education, Experience and Skills Preferred: