Global Study Director CAR-T - BioPharma R&D at AstraZeneca in Gaithersburg, Maryland

Job Description:

Do you have a passion for Science? Would you like to apply your expertise to impact a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you!


At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being high-reaching, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you're our kind of person.



Summary:



Are you ready to play a pivotal role in our BioPharmaceuticals Clinical Operations team and shaping the future of clinical research? We are seeking a dynamic Global Study Director (GSD) to provide strategic direction and lead the planning and delivery of high-priority and complex clinical studies that are on the cutting edge of Immunology with a specialized emphasis on CAR-T.




Responsibilities:

• Provides strategic and operational insight into the design and delivery of global clinical programs, particularly in the development of innovative CAR-T therapies for autoimmune diseases.
  
  


• Taking accountability for the operational planning, leadership, and delivery of multiple studies or being responsible for sophisticated complex/novel studies across assets to ensure they meet set timelines, cost, and quality standards.
  
  


• Supplying authority clinical operational input into project strategy and study design, and engaging in operational interactions with external entities, including regulatory agencies and external collaborators.
  
  


• Leading, providing mentorship, and delegating appropriately to a cross-functional study team to ensure the clinical study progresses as planned, driving achievement of breakthroughs according to timelines, budget, and quality standards.
  
  


• Facilitating communication across all functions, collaborating with other teams to establish strategies and identify commonalities sought at growing efficiency of global study teams.
  
  


• Leading and conducting investigator meetings and other study-related meetings and contributing to the development of crucial study documents in accordance with relevant AZ SOPs.
  
  


• Helping to craft AstraZeneca's approach to drug development in the innovative cell therapy field.
  
  

Required Education & Experience:

• A Bachelors Degree preferably in medical or biological sciences or a subject area associated with clinical research.
  
  


• 
  Must have at least 2 plus years in CAR-T program development and execution
  
  
  


• Minimum of 7 years dynamic experience in clinical research, with at least 5 years of clinical development project management experience (or equivalent).
  
  


• Extensive knowledge of ICH-GCP, relevant regulatory/ethics requirements, and clinical/drug development, as well as a thorough understanding of cross-functional clinical processes.
  
  

Desired Qualifications:

• Advanced degree- Masters level education (or higher).
  
  


• Background in immunology, specifically in autoimmune diseases program development and execution
  
  


• Project management certification and shown experience on a global level.
  
  


• Experience in all phases of a clinical study lifecycle.
  
  

When we put unexpected teams in the same room, we fuel bold thinking with the power to encourage life-changing medicines. In-person working gives 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 world.


The annual base pay (or hourly rate of compensation) for this position ranges from $154,724 to $232,086. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an "at-will position" and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.


At AstraZeneca, we are committed to turning our drug development strategies into reality. We work at all stages of development to translate our life-changing science into medicines to get the best results for AstraZeneca, patients in need and healthcare professionals. We are a diverse and open-minded team harnessing our different skills and experiences. Our differences enable us to explore new ideas and ways of doing things. It keeps us on our toes and excited for what's next. We are part of the solution, involved in key discussions. In our role we act as both a drug developer and Regulator. We think broadly about patients and what it takes to prevent and treat diseases to develop progressive solutions. Are you ready to lead the way for a new breed of solutions-oriented Regulators? Champion a new approach to Regulatory that supports quick decision-making and balanced risk-taking. Apply now to join our efficient and nimble team at AstraZeneca!


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. Apply Now