AstraZeneca
Senior Director, Early Clinical Development, Immunology / Gastroenterology
AstraZeneca, Gaithersburg, Maryland, us, 20883
Are you ready to make a significant impact in the world of drug development?
This is an excellent time to join a team of clinical researchers, clinical scientists, and physicians who are translating scientific discoveries into early phase clinical development plans and clinical studies across a wide range of diseases.
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 pioneering science, innovative drug discovery approaches, and key collaborations with academic centers around the world. We are investigating a wide range of drug modalities – small molecules, biologics, oligonucleotides, and cell therapies – across multiple diseases with high unmet medical need.
Early Clinical Development in R&I 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.
What You Will Do
You will be responsible for managing and contributing to early phase I-2b 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 as writing protocols, key study and health authority documentation, medical monitoring, and ensuring timely delivery of studies, all in collaboration with relevant internal and external partners and clinical research organizations.
Location options:
US: Boston or Gaithersburg, MD
Spain: Barcelona
Sweden: Gothenburg
Basic Qualifications:
Advanced degree in relevant scientific subject area (MD, PhD, or PharmD), clinical training in gastroenterology/inflammatory bowel disease and/or research training in immunology or cell therapy a plus
Minimum of 9 years of 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 of relevant regulatory documents, including INDs, protocols, ICFs, PIPs, briefing books as well as 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.
Detailed understanding of FDA, MHRA, and ICH GCP guidelines to ensure the appropriate conduct of global clinical studies.
Attention to detail, internal drive to generate high-quality work, and a sense of passion and urgency to achieve team and program goals.
Demonstrated experience managing complex projects and working collaboratively with multiple stakeholders.
Outstanding communication skills.
Excellent analytical, problem-solving, and strategic planning skills.
Ability to thrive in a fast-paced environment.
At AstraZeneca, we are dedicated to being a Great Place to Work. Our team is inclusive and diverse, working in a solution-oriented, trusting, and collaborative work environment. We are committed to improving healthcare and quality of life for patients across a wide range of diseases and disorders by developing innovative therapies. Join us in the Biopharmaceuticals R&D department and contribute to our growing pipeline!
#J-18808-Ljbffr
This is an excellent time to join a team of clinical researchers, clinical scientists, and physicians who are translating scientific discoveries into early phase clinical development plans and clinical studies across a wide range of diseases.
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 pioneering science, innovative drug discovery approaches, and key collaborations with academic centers around the world. We are investigating a wide range of drug modalities – small molecules, biologics, oligonucleotides, and cell therapies – across multiple diseases with high unmet medical need.
Early Clinical Development in R&I 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.
What You Will Do
You will be responsible for managing and contributing to early phase I-2b 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 as writing protocols, key study and health authority documentation, medical monitoring, and ensuring timely delivery of studies, all in collaboration with relevant internal and external partners and clinical research organizations.
Location options:
US: Boston or Gaithersburg, MD
Spain: Barcelona
Sweden: Gothenburg
Basic Qualifications:
Advanced degree in relevant scientific subject area (MD, PhD, or PharmD), clinical training in gastroenterology/inflammatory bowel disease and/or research training in immunology or cell therapy a plus
Minimum of 9 years of 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 of relevant regulatory documents, including INDs, protocols, ICFs, PIPs, briefing books as well as 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.
Detailed understanding of FDA, MHRA, and ICH GCP guidelines to ensure the appropriate conduct of global clinical studies.
Attention to detail, internal drive to generate high-quality work, and a sense of passion and urgency to achieve team and program goals.
Demonstrated experience managing complex projects and working collaboratively with multiple stakeholders.
Outstanding communication skills.
Excellent analytical, problem-solving, and strategic planning skills.
Ability to thrive in a fast-paced environment.
At AstraZeneca, we are dedicated to being a Great Place to Work. Our team is inclusive and diverse, working in a solution-oriented, trusting, and collaborative work environment. We are committed to improving healthcare and quality of life for patients across a wide range of diseases and disorders by developing innovative therapies. Join us in the Biopharmaceuticals R&D department and contribute to our growing pipeline!
#J-18808-Ljbffr