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Senior Medical Director / Senior Director, Early Clinical Research Early R&I Clinical Development, Immunology / Rheumatology

Ort Gaithersburg, Maryland, USA Boston, Massachusetts, USA Göteborg, Västra Götaland County, Schweden Anzeigen-ID R-196799 Veröffentlichungsdatum 10/07/2024

Location

US: Boston or Gaithersburg, MD

Spain: Barcelona

Sweden: Gothenburg

Are you an experienced drug developer with expertise in immunology, rheumatology or inflammatory bowel disease? Would you like to be a part of a talented and high performing team of clinical research professionals, clinical scientists and physicians who are translating scientific discoveries into early phase clinical development plans and clinical studies across a wide range of diseases?

This role will be located at one of our Global Research and Development strategic sites, in the US, Spain or Sweden.

At AstraZeneca, we’re dedicated to being a Great Place to Work with an inclusive and diverse team who work in a solution-oriented, trusting, and collaborative work environment. We are dedicated to improving the health care and quality of life for patients across a wide range of diseases and disorders by developing innovative therapies that address unmet clinical needs and provide clinicians with novel evidence-based treatment options to optimize the care of their patients.

Who We Are

In the Respiratory and Immunology Early Clinical Development team, we are investigating the drivers of key respiratory and immunology diseases, with access to cutting edge science, innovative drug discovery approaches and key collaborations with academic centers around the world. We are investigating a wide range of different drug modalities – small molecules, biologics, oligonucleotides and cell therapies – across multiple diseases with high unmet medical need.

Early Clinical Development, part of the Early R&I organization, is where science meets clinical drug development with a focus upon delivering innovative, early phase clinical studies (Phase 1 – Phase 2b), while collaborating closely with our late phase clinical development colleagues who guide our phase 3 clinical studies. We are a diverse team of experienced physicians and clinical scientists who collaborate with scientists and translational medicine colleagues to define our early phase clinical development strategies, design innovative phase 1-2b clinical trials, develop and validate new clinical endpoints and translate scientific ideas to proof-of-concept studies in targeted patient populations.

We are recruiting for a Senior Medical Director (physician) and/or Senior Director (clinical scientists). In this role, you will have the opportunity to work at the forefront of early clinical and translational research within immunology at AZ. In a multidisciplinary environment, you will play a key role in progressing a rich and diverse pipeline in numerous active clinical programs.

What You Will Do

You will be responsible for managing and contributing to early phase I-IIb global clinical trials and related clinical research projects for compounds that are targeting immunology indications ranging from SLE and RA to IBD, as well as serving as an expert on the design, conduct, monitoring, data interpretation, and reporting of these studies. Additionally, you will work on cross-functional teams within our ECD group and across the broader early R&I organization that are framing our strategies and development plans for compounds that are a range of indications, including asthma, COPD and additional immunology indications.

You will take responsibility for clinical development in cross-functional teams to support early phase clinical development activities. These activities include the creation of overall clinical development plans and clinical study design as well writing protocols, key study and health authority documentation, medical monitoring and ensuring timely delivery of studies, all in close collaboration with relevant internal and external partners and clinical research organizations.

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 oversee the 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 Clinical Development and the wider organization to transform trends and emerging data into agile and innovative clinical plans.
  • Represent Early R&I Clinical Development at internal governance interactions and with external stakeholders, including Investigators, key external experts and patient advocacy groups (eg regulatory, site, CROs and KEEs)
  • Medical lead for regulatory communication 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.

Who You Are

We believe you are a medical doctor with relevant specialty clinical training or scientist with an advanced scientific degree (PhD or Pharm D) and training relevant for the role. We believe you will have had a minimum of 7-10 years of clinical research experience, including significant experience in early phase drug development in non-oncology diseases within the biopharmaceutical/biotechnology industry.  You will thrive in a fast-paced, proactive can-do culture, be a highly effective internal and external team player, as well as a strong communicator and collaborator.

Required Education Skills and Experience

  • Advanced degree in relevant scientific discipline (MD, PhD, PharmD), with relevance for immunology / rheumatology a plus. Subject matter expertise in rheumatology, immunology and /or inflammatory bowel disease via training and/or experience strongly preferred.
  • Must have significant experience (more than 9 years experience) in early phase clinical development, including hands-on experience in the design, delivery and interpretation of multiple Ph1 / Ph2 studies in relevant non-oncology indications
  • 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 and non-clinical study design and execution, and a thorough understanding of clinical research methodology and biostatistics principles, to facilitate innovative and efficient clinical trial design, and clinical development plans with clear data-driven decision rules.
  • Thorough command of FDA, MHRA and ICH GCP guidelines to ensure the appropriate conduct of global clinical studies in the United States, Europe and rest of world.
  • Attention to detail, internal drive to generate high-quality work, and sense of passion and urgency to achieve team and program goals.
  • Demonstrated experience managing complex projects and working collaboratively with multiple stakeholders regarding new strategies to ensure consistent communication.
  • Demonstrated track record in delivering results.
  • Outstanding verbal and written communication skills.
  • Excellent analytical, problem solving and strategic planning skills.
  • Ability to thrive in a fast-paced environment.

Why AstraZeneca?

Here, we need leadership at every level - leaders who not only have expertise, but also the ability to build a case, engage multiple partners, and communicate effectively with different audiences. Early clinical development is at the forefront of discovery of new medicines for patients with high unmet need. With that kind of remit comes great responsibility. Your curiosity and passion for personal development combined with support from colleagues, mentors and leaders, will ensure you maximize your skills, abilities and contribution. We offer a competitive salary and excellent benefits.

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working give us the platform we need to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn’t mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious culture.

So, what’s next?

Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you. Welcome to apply!

Where can I find out more?

AstraZeneca Boston: https://www.astrazeneca.com/r-d/our-strategic-r-d-centres.html

R&I at AstraZeneca:
https://www.astrazeneca.com/our-therapy-areas/respiratory-and-immunology.html


This is what we’re made of: https://www.youtube.com/watch?v=pmFx_jr2eFo&t=2s



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