Clinical Research & Development Associate Principal Scientist

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.