Clinical Research & Development Associate Principal Scientist

Socket.dev; Gaithersburg (MD); On-site; USD 120,000 - 180,000; Full time

Job summary

Socket.dev seeks a senior Clinical Scientist to lead the full lifecycle of clinical research projects, from strategy to execution. You will guide multidisciplinary teams, ensure scientific integrity, and align business objectives with regulatory requirements.

The role emphasizes independence, process innovation, and compliance with GCP/ICH standards across trials, with responsibility for planning input, budgets, and timelines while mentoring teams.

Qualifications

• Essential: Bachelor's degree in a scientific field with experience in pharmaceutical drug development and clinical trials.
• Desirable: Advanced degree (Master’s/PhD/PharmD) and leadership in cross-functional teams through regulatory submissions.
• Strong knowledge of GCP, ICH guidelines, regulatory requirements, and clinical study design.

Responsibilities

• Provide specialist scientific and technical expertise for clinical research and development; act as a subject matter expert.
• Coordinate cross-functional input to advance drug projects through development stages and regulatory submissions.
• Design and optimize clinical development strategies and protocols for regulatory viability and commercial considerations.

Skills

Clinical development

GCP/ICH knowledge

Education

Bachelor's degree in a scientific field

Master’s/PhD/PharmD (preferred)

Job description

What You Will Do

Expert in the field of drug research and development, contributing deep specialist knowledgeof inflammatory myopathies, JIA and /or Sjogren’s Disease. Operatewith significant independence,integrate advanced scientific, operational, and commercialexpertiseto guide the full lifecycle of clinical research and development projects.Ensure alignment of scientific and businessobjectivesacross 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 technicalexpertisefor clinical research and development, acting as asubject matter expertboth 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, andoptimizeclinical 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 andtimelydelivery of clinical documents, submissions, and regulatory materials (such as CSRs, CTDs, INDs, and annual reports), ensuringappropriate inputfrom 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, leveragingnew technologiesand best practices.
• Oversee risk and contingency planning for clinical projects, proactively managing issuesimpactingquality, 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.
• Continuouslymonitor, interpret, and share relevant scientific, commercial, and regulatory developments, integrating insights into ongoing projects.
• Contribute significantly to decision-makingregardingthe 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,creativityand collaboration

QualificationsandSkills

• 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, PhDor equivalent qualificationin a relevant scientific field (advanced degree preferred);Significant experience in the pharmaceutical industry;Proven leadership in cross-functional teamsand 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 toReachSolutions

• 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.