Senior Medical Director, Early R&i
hace 3 semanas
**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 first-in 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 cross-functional alignment across wider AZ organization
- Provide clinical development /disease expertise to Research, Translational Medicine, Early and Late-stage 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 in-licensing 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 non-oncology indications
- Must have significant experience of more than 8 years in clinical development, including hands-on 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 data-driven 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 high-quality 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**:
- Subject matter expertise in rheumatology, immunology and /or inflammatory bowel disease via training is strongly preferred
- Experience with cell th
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