Global Development Scientist Director

Are you an authority in clinical drug development, possessing the capabilities to drive a successful strategy in accelerating the development of cellular therapies for patients with immune-mediated diseases? Are you dedicated to revolutionizing the treatment of immune-mediated diseases and crafting a significant impact on patients' lives? Do you have a passion for science and clinical development experience in Immunology and CAR-T cell therapies? Do you possess both strategic and operational leadership skills? If so, we invite you to join us! We are currently seeking a Global Development Scientist Director to be based in Boston Seaport.

About AstraZeneca

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world’s most serious diseases. We are more than one of the world’s leading pharmaceutical companies.

Immunology Cell Therapy

Our ambition is to build a premier organization that accelerates the delivery of ground-breaking cell therapies for patients with immune mediated diseases. It’s our vision that unites and encourages us. Cell therapies represent a fundamental evolution of how drugs are discovered, developed and manufactured, these new advanced potentially curative cellular modalities require a development strategy to ensure their rapid availability to patients. With multiple autoimmune and inflammatory indications and clinical stage cell therapies in global development, we actively move forward. Focus on pioneering science with the latest technology to achieve breakthroughs. AZ is a place built on courage, curiosity and collaboration – we make ambitious decisions driven by patient outcomes.

Responsibilities

The Global Development Scientist Director will provide scientific and clinical input to all aspects of late-stage product development. This includes but is not limited to the design, delivery and interpretation of pivotal clinical trials and of studies that further characterize the overall benefit and risk and value of products in respiratory and immunology therapeutic area (TA) in late-stage development. In this role the scientist will seek input from the appropriate functional authorities and will coordinate these activities in support of clinical studies and programs.

The Global Development Scientist Director ensures that the safety evaluation process for the pivotal phase III trials is seamless and complete.

The objectives of the Global Development Scientist Director will be set by the Global Clinical Product Lead in agreement with Global Clinical Head(s).

The role will have a special focus on late-stage clinical trials within the respiratory and immunology TA where the Global Development Scientist Director will work in close collaboration with the study team physician and other collaborators with all aspects of scientific input, clinical data quality metrics and safety evaluation.

You will be expected to effectively collaborate with colleagues in the late stage respiratory and immunology development and early development groups. Other capabilities are to demonstrate clear and professional verbal and written communication, presenting scientific results to multidisciplinary teams and key collaborators. Work as a member of a diverse and motivated team of scientists spanning across multiple divisions of Biopharmaceuticals R&D.

The Global Development Scientist Director will lead independently some activities and contribute to regulatory submissions, process improvement, and mentoring.

Accountabilities

• Provide scientific leadership in the design, execution, and interpretation of clinical trials in one or more development programs.
• Effectively collaborate with colleagues in other functions including Patient Safety, Regulatory Affairs, and Clinical Operations, and early development groups.
• Be involved primarily in late stage (Ph2b and Phase 3) clinical programs but will be expected to collaborate with clinical colleagues supporting early-stage programs as well as medical affairs colleagues.
• Provide experienced scientific input into the preparation of regulatory documents and interactions with regulatory authorities.
• Provide expert scientific analysis and interpretation of data from studies and in the literature.
• Lead development of quality metrics and data review plan for assigned studies.
• Support and contribute to medical monitoring of trials.
• Lead and participate in activities that ensure quality, consistency and integration of clinical study related deliverables and ensure safety evaluation process within the clinical team.
• Ensure scientific input to TA standards.
• Provide scientific evidence to support strategic de