Clinical Research & Development Associate Principal Scientist

AstraZeneca•Gaithersburg, MD

About The Position

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.

Requirements

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.

Nice To Haves

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.

Responsibilities

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.