Clinical Research & Development Associate Director

Socket.dev; Gaithersburg (MD); On-site; USD 180,000 - 240,000; Full time

Job summary

Socket.dev is seeking a senior leader to drive development and delivery of novel therapies for inflammatory diseases with cross-functional scientific, clinical, and commercial expertise. You will integrate research strategies, design robust studies, and oversee global development from early research through lifecycle management.

Key focus includes coordinating CROs, steering committees, regulatory submissions, and cross-border collaboration to ensure product value, patient impact, and regulatory

Qualifications

• Advanced clinical degree and broad drug development knowledge.
• Excellent English communication; able to travel internationally.
• Desirable: mentoring, change management and collaboration skills.

Responsibilities

• Integrate research and commercial aspects of drug development to guide product development and lifecycle.
• Plan, monitor, and manage delivery of clinical development study components, timelines and budgets.
• Lead CRO selection and manage external partners for quality delivery to standards.
• Contribute to regulatory submissions and cross-functional decision making.

Skills

Drug development process

Oral and written English

Travel ability (national/international

Cross-functional collaboration

Education

Advanced clinical degree (M.D., PhD, or equivalent)

Tools

AstraZeneca project management tools

Job description

What You Will Do

A leadership role combining clinical, scientific, commercial, and operational expertise to drive the successful development and delivery of novel therapeutic approaches for inflammatory myopathies, JIA, and/or Sjogren’s Disease. Responsible for integrating research and development strategies, ensuring robust, commercially viable study designs and execution, and optimizing cross-functional collaboration from early research through to late-stage clinical development and lifecycle management.

Typical Accountabilities

• Integrate the research and commercial aspects of drug development to ensure successful, value creating product development, either by overseeing a team of clinical research professionals, or by supporting such a team as an expert in one or more areas of clinical research


• Design and oversee studies to assess both scientific and commercial viability of drugs and portfolios, interpreting results as team head or expert contributor.


• Maintaina continuous focus on both scientific rigor and commercial goals, ensuring products meet regulatory, market, and patient needs throughout their lifecycle.


• Plan, monitor, and manage the delivery of all clinical development study components, including operational feasibility assessment, timelines, budgets, risk/contingency planning, and resource allocation.


• Provide strategic and operational input into global clinical development plans and ensures implementation of agreed processes, technologies, and best practices.


• Lead theselectionand negotiation processes for CROs and external partners, ensuringtimely, quality delivery to specified standards.


• Participatein steering committees, regulatorydefenseteams, and submission assemblies; coordinates and contributes to the preparation of submission documentation for regulatory authorities.


• Serve as a communication bridge between internal and external stakeholders, ensuring alignment andtimelydissemination of critical project information throughout the product lifecycle.


• Champion and sustains a culture of courageous leadership, innovation, and collaboration; develops and mentors clinical research and development staff in support of professional growth and project excellence.


• Monitorteam and project performance, provides constructive feedback, and ensure compliance with Safety, Health, Environment, and all other relevant internal or external standards and regulations.

Qualifications and Skills

• Essential: Advancedclinicaldegree (M.D., PhD, or equivalent) in a scientific, medical, or health-related discipline; Comprehensive knowledge of the drug development process; Demonstrated knowledge of AstraZeneca line and project management tools and processes; Good understanding of the therapeutic areas related to AZ products; Ability to understand integrated worldwide and regional delivery needs; Very good knowledge of oral and written communication in English; Ability to travel nationally and internationally




• Desirable: Ability to mentor, develop and educate staff; Proven leadership promoting motivation and empowerment of othersin order toaccomplishindividual, team andorganizationalobjectives; Manages change with a positive approach and flexibility to the challenges of change for self,teamandbusiness. Sees change as an opportunity to improve performance and add value to the business; Ability to look for and champion more efficient and effective methods/processes of delivering Clinical Developmentfocusingon key performance metrics around reliability, productivity, cost and quality; Excellent written and verbal communication skills,negotiation, collaboration and interpersonal skills with ability to work effectively with others at all levels of the organization; Demonstrated ability to set and manage priorities, resources, performance targets and project initiatives in a regional and local environment; Integrity and high ethical standards

Key Relationships to Reach Solutions

• Internal:Study Delivery personnel; Data Management Centre representatives; Clinical Project Team and therapy area personnel; Clinical Development personnel; Clinical Pharmacology Units; Study Site personnel; Regional Monitoring personnel; Other SkillCentreas appropriate




• External: External service providers; Clinicians and scientists; Patient advocacy groups; Alliance site partners

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.