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 R each S olutions

Internal:

Clinical project and development teams ; study delivery personne l; 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. 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Clinical Research & Development Associate Principal Scientist