AstraZeneca

Clinical Research & Development Associate Principal Scientist

Full-time · US - Gaithersburg - MD
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Senior

Requirements

Education: Bachelor's degree

Skills & tools

ResearchOperationsMarketingClinical DevelopmentRecruitingClinical TrialsProject ManagementFinancial Analysis
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Full job description

What You Will Do Expert in the field of drug research and development, contributing deep specialist knowledge of inflammatory myopathies, JIA and /or Sjogren's Disease. Operate with significant independence, integrate advanced scientific, operational, and commercial expertise to guide the full lifecycle of clinical research and development projects.

Ensure alignment of scientific and business objectives across multiple functions for drug candidates, actively lead multidisciplinary teams, steer project strategy and execution, and champion process innovation and compliance to deliver high-impact results. Accountabilities - Provide specialist scientific and technical expertise for clinical research and development, acting as a subject matter expert both internally and externally. - Plan, coordinate, and direct input from cross-functional teams-spanning research, development, regulatory, marketing, and manufacturing-to advance a portfolio of drug projects through all phases of the development process. - Design, implement, and optimize clinical development strategies and protocols, ensuring scientific integrity as well as commercial and regulatory viability. - Execute recruitment strategies and lead the operational planning for clinical studies, including timeline, budget forecasting, feasibility, and resource allocation. - Plan the preparation and timely delivery of clinical documents, submissions, and regulatory materials (such as CSRs, CTDs, INDs, and annual reports), ensuring appropriate input from all stakeholders. - Manage activities associated with audits to ensure compliance with GCP, ICH, AZ standards, and local/international regulations. - Guide and support initiatives to improve the efficiency and quality of the clinical development process, leveraging new technologies and best practices. - Oversee risk and contingency planning for clinical projects, proactively managing issues impacting quality, budget, and timelines and escalating appropriately. - May mentor and manage clinical research professionals and study teams, providing performance management and supporting career growth. - Ensure comprehensive and ongoing training for investigators and monitors to uphold study delivery standards. - Continuously monitor, interpret, and share relevant scientific, commercial, and regulatory developments, integrating insights into ongoing projects. - Contribute significantly to decision-making regarding the scientific and commercial viability of drug candidates, including go/no-go and resource investment decisions. - Has personal responsibility for creating a culture of courageous leadership, creativity and collaboration Qualifications and Skills Essential: Bachelor's degree in a scientific field, or equivalent qualification.; Considerable experience in the pharmaceutical industry, particularly in drug development; Experience managing and interpreting the results of clinical trials.

Knowledge of autoimmune disease biology, clinical manifestations and treatments, knowledge of relevant scientific literature and clinical trials. Desirable: Master's, PharmD, PhD or equivalent qualification in a relevant scientific field (advanced degree preferred); Significant experience in the pharmaceutical industry; Proven leadership in cross-functional teams and complex clinical projects from design through to regulatory submission; In-depth knowledge of GCP, ICH, drug development processes, and regulatory requirements; Strong strategic, analytical, and project management skills, including budget/resource management and risk planning; Excellent communication, negotiation, and stakeholder management capabilities.

Key Relationship to Reach Solutions Internal: Clinical project and development teams; study delivery personnel; manufacturing; regulatory; marketing/business development; therapy/brand leaders; data management; pharmacology; regional/monitoring teams. External: Regulatory bodies; external service providers; clinical sites; marketing company personnel.

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. AstraZeneca is a global, science-led, patient-focused biopharmaceutical company. We focus on discovering, developing and commercialising prescription medicines for some of the world's most serious diseases.

But we are more than one of the world's leading pharmaceutical companies. At AstraZeneca, we're dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science, challenge convention and unleash your entrepreneurial spirit.

To embrace differences and take bold actions to drive the change needed to meet global healthcare and sustainability challenges. There is no better place to make a difference in medicine, patients, and society. An inclusive culture where you will connect different thinking to generate new and valuable opportunities.

Where you will find a commitment to lifelong learning, growth and development for all. Our Inclusion & Diversity (I&D) mission is to create an inclusive and equitable environment where people belong, using the power of our diversity to push the boundaries of science to deliver life-changing medicines to patients. Inclusion and diversity are fundamental to the success of our company, because innovation requires breakthrough ideas that only come from a diverse workforce empowered to challenge conventional thinking.

We're curious about science and the advancement of knowledge. We find creative ways to approach new challenges. We're driven to make the right choices and be accountable for our actions.

As an organisation centred around what makes us human, we put a big focus on people. Across our business, we want colleagues to wake up excited about their day at the office, in the field, or in the lab. Along with our purpose to bring life-changing medicines to people across the globe, we have a promise to you: to help you realise the full breadth of your potential.

Here, you'll do work that has the potential to change your life and improve countless others. And, together with your team, you'll shape a culture that unites and inspires us every day. This is your life at AstraZeneca.

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