BioPharma Fellows Program - Associate Director, Clinical Development
AstraZeneca

Job Info

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Are you an experienced clinician, or scientist, with clinical research experience in either immunology, cell therapy or metabolism-related diseases? Would you like to be part of a dedicated and high performing team of clinical research professionals, clinical scientists, and physicians who are translating rigorous scientific discoveries into early and late phase clinical development plans and studies across a wide range of chronic and debilitating diseases?

The AstraZeneca BioPharma Fellows Program, is a newly developed, competitive, 12-month immersive research and training program in clinical development for early-career physicians and scientists who are inspired by science and by how clinical development has the potential to transform patient care. As part of the selected cohort of fellows, you'll have an opportunity to learn from a diverse group of experts across the drug development continuum and play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients' lives. We are currently recruiting for the 2025 class, aimed at beginning the fellowship in the summer of 2025.

This is an office-based role that is located at AstraZeneca's vibrant R&D site in Boston (Seaport Blvd), Massachusetts, transferring to our purpose-built facility in Kendall Square once it opens in 2026.

At AstraZeneca, we are dedicated to building an outstanding work environment where diversity and inclusivity thrive, encouraging collaboration and trust among our team members. We're pushing the boundaries of science to deliver life-changing medicines to patients, with a passion for discovery and a pipeline to show for it. 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 (R&I) Late Clinical Development team, we are investigating the novel and advanced science of R&I diseases to deliver life-changing medicines to patients. Our ambition is to pioneer innovative research and explore novel therapeutic pipelines to become the worldwide leading company in immunology. With such passion, our portfolio includes various gastrointestinal, rheumatology, immunology, and respiratory diseases.

In Immunology Cell Therapy, we are advancing our growing ambition in immunology by driving next-generation cell therapies (including CAR-T cells and other modalities) with the potential to restore immune tolerance and possibly cure immune-mediated and inflammatory diseases. Our innovative approaches and deep expertise in cell therapy give us an opportunity to deliver life-changing therapeutics to patients. This is an excellent program to provide medical and scientific input to T-cell therapy clinical stage assets working in collaboration with and learning from cross-functional teams including basic research, clinical pharmacology and translational medicine, clinical operations, medical directors, safety, regulatory affairs, biostatistics, cell product manufacturing, and commercial.

In the Cardiovascular, Renal & Metabolism (CVRM) Early Clinical Development team, we are investigating the drivers of CVRM disease progression through ground-breaking scientific methods and data-driven drug discovery approaches. In this context, we are investigating a wide range of different drug modalities from our rich CVRM portfolio of compounds across diverse metabolic patient populations including obesity, T2DM, and MASH.

Early Clinical Development (ECD), part of the Early CVRM organization, is where science meets clinical drug development with a focus upon delivering innovative, early phase clinical studies and accelerating human target validation while collaborating closely with our late phase clinical development and regulatory colleagues who guide our pivotal phase 3 clinical studies. We are a diverse team of experienced physicians and clinical scientists who collaborate to delineate early phase clinical development strategies, design innovative phase I-IIb clinical trials, develop and validate novel surrogate endpoints, and translate scientific ideas to proof-of-concept studies in targeted patient populations.

What you'll do

The 2025 AstraZeneca BioPharma Fellows will join AstraZeneca at a time of tremendous growth and acceleration in the BioPharma portfolio. This rotational program will allow you to work in Early and Late Clinical development, ending with a fixed placement in one of our development teams.Working in a fast-paced and dynamic work environment, you will experienceincreasing levels of responsibility, following a structured learning plan in the following domains:

• Scientific support for the development and maintenance of clinical projects strategies including the latest thinking about mechanisms of disease, diagnostic approaches, current treatment options, drug development trends, and regulatory requirements in relevant disease and therapeutic areas.
  
• Providing long-range clinical development planning.
  
• Planning and managing clinical development programs.
  
• Collaborating with, and providing clinical input and expertise to, pre-clinical and translational sciences.
  
• Learning and working with regulatory and biostatistics teams.
  

In addition, you will participate in regular clinical and scientific meetings related to your project, attend training programs through the course of the program, and participate in internal and external AstraZeneca and scientific meetings. You will serve as the lead for a longitudinal clinical project. Specific duties and major responsibilities may include any of the following:

• Establishing and approving scientific methods for design and implementation of applicable clinical protocols, data collection systems, and final reports.
  
• Assisting in design of clinical development plans and overall strategy for compounds, therapeutic classes of compounds or indications in light of recent developments in the therapy area of interest.
  
• Collaborating with pre-clinical and translational sciences and senior management in assessing requirements for emerging products.
  
• Participating in the selection and management activities of Clinical Research Organizations (CROs).
  
• Supervising project team members in planning, conducting and evaluating clinical trials.
  
• Planning and managing investigator meetings, advisory boards and other scientific committees.
  
• If you are medically qualified, serving as the medical monitor with primary responsibility for patient safety and conduct of assigned trials, as well as overall data interpretation and safety surveillance.
  

You will work in a global, cross-functional environment with representatives from other functions as well as Early and Late-Stage Development. You will contribute to and support Department/Clinical initiatives to improve the quality and content of all clinical programs as well as the cross functional/organization processes designed to effectively deliver our R&D portfolio.

Minimum Qualifications:

• Experienced scientist with a PhD qualification or an MD, potentially also with other advanced masters or doctoral degrees.
• At least 5 years' experience working in a clinical practice or research setting and a good publication track record.
  
• Demonstrated scientific knowledge in one of the areas of interest i.e. metabolism-related diseases (e.g. T2Dm, obesity, MASH), immunology (e.g., gastroenterology or rheumatology diseases), respiratory or cell therapy.
  
• Evidence of strong collaborative working, a delivery focus and good communication skills is essential.
  
• Must be a U.S. Citizen or Permanent Resident.
  

Desirable Qualifications:

• Additional advanced academic degrees, such as PhD, MPH, etc.
  
• If you are medically qualified, medical specialty and sub-specialty training and board certification.
  
• If you are a PhD qualified scientist, experience in clinical trials or relevant clinical/basic research.
  
• Results driven to achieve creative and sound outcomes.
  
• Proven leadership skills and demonstrated ability to interact collaboratively in a cross-functional environment.
  
• Ability to make sound and timely decisions; agile in learning and action-oriented.
  
• High level of emotional intelligence; able to deal with ambiguity.
  
• Able to relate to varied level audiences across the organization; able to set priorities for team and maintain accountability; skilled in negotiating organizational boundaries and hierarchy; able to build effective teams.
  

So, what's next?

• Complete your application before the below closing date.
  
• This role is open from 11/08/2024, we invite you to apply no later than 12/20/2024.
  

Where can I find out more?

Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/

Follow AstraZeneca on Facebook https://www.facebook.com/astrazenecacareers/

Follow AstraZeneca on Instagram https://www.instagram.com/astrazeneca_careers/?hl=en

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

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