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Clinical Research & Development Associate Director

AstraZeneca

MD, Gaithersburg, USonsite

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About this role

What You Will Do A leadership role combining   clinical,   scientific, commercial, and operational   expertise   to drive the successful development and delivery of novel therapeutic   approaches   for inflammatory   myopathies, JIA, and/or Sjogren’s Disease . Responsible for integrating research and development strategies, ensuring robust, commercially   viable   study designs and execution, and   optimizing   cross-functional collaboration from early research through to late-stage clinical development and lifecycle management.  

Typical   Accountabilities  

•Integrate the research and commercial aspects of drug development to ensure successful, value creating product development, either by overseeing a team of clinical research professionals, or by supporting such a team as an expert in one or more areas of clinical research     • Design and oversee studies to assess both scientific and commercial viability of drugs and portfolios, interpreting results as team head or expert contributor.     •   Maintain   a continuous focus on both scientific rigor and commercial goals, ensuring products meet regulatory, market, and patient needs throughout their lifecycle.     • Plan, monitor, and manage the delivery of all clinical development study components, including operational feasibility assessment, timelines, budgets, risk/contingency planning, and resource allocation.     • Provide strategic and operational input into global clinical development plans and ensures implementation of agreed processes, technologies, and best practices.     • Lead the   selection   and negotiation processes for CROs and external partners, ensuring   timely , quality delivery to specified standards.     •   Participate   in steering committees, regulatory   defense   teams, and submission assemblies; coordinates and contributes to the preparation of submission documentation for regulatory authorities.     • Serve as a communication bridge between internal and external stakeholders, ensuring alignment and   timely   dissemination of critical project information throughout the product lifecycle.     • Champion and sustains a culture of courageous leadership, innovation, and collaboration; develops and mentors clinical research and development staff in support of professional growth and project excellence.     •   Monitor   team and project performance, provides constructive feedback, and ensure compliance with Safety, Health, Environment, and all other relevant internal or external standards and regulations.      

Qualifications   and   Skills  

• Essential :   Advanced   clinical   degree (M .D. , PhD, or equivalent) in a scientific, medical, or health-related discipline ; Comprehensive knowledge of the drug development process; Demonstrated knowledge of AstraZeneca line and project management tools and processes; Good understanding of the therapeutic areas related to AZ products; Ability to understand integrated worldwide and regional delivery needs; Very good knowledge of oral and written communication in English; Ability to travel nationally and internationally  

• Desirable :   Ability to mentor, develop and educate staff; Proven leadership promoting motivation and empowerment of others   in order to   accomplish   individual, team and   organizational   objectives ; Manages change with a positive approach and flexibility to the challenges of change for self,   team   and   business . Sees change as an opportunity to improve performance and add value to the business; Ability to look for and champion more efficient and effective methods/processes of delivering Clinical Development   focusing   on key performance metrics around reliability, productivity, cost and quality; Excellent written and verbal communication skills,   negotiation, collaboration and interpersonal skills with ability to work effectively with others at all levels of the organization; Demonstrated ability to set and manage priorities, resources, performance targets and project initiatives in a regional and local environment; Integrity and high ethical standards  

Key Relationship to   R each   S olutions  

• Internal:   Study Delivery personnel; Data Management Centre representatives; Clinical Project Team and therapy area personnel; Clinical Development personnel; Clinical Pharmacology Units; Study Site personnel; Regional Monitoring personnel; Other Skill   Centres   as appropriate  

• External:   External service providers;   Clinicians and scientists; Patient advocacy groups ; Alliance site partners  

Date Posted 09-Aug-2026 Closing Date 03-Sep-2026 Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.

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