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Associate Director Clinical Research jobs in United States
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AstraZeneca · 1 month ago

Associate Director Clinical Research

AstraZeneca is a pharmaceutical company committed to innovation in drug development. The Associate Director Clinical Research (ADCR) is responsible for managing clinical studies and leading a team of Clinical Research Associates and Clinical Study Administrators to ensure successful study delivery in compliance with regulatory standards.
PharmaceuticalBiotechnologyHealthcareMedical DeviceBiopharmaHealth CareMedicalPrecision Medicine
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Comp. & Benefits

Responsibilities

Provide leadership to a dedicated team, fostering team spirit and cultivating a positive, high-performing team climate and professional behavior
Ensure adequate resourcing for all assigned clinical studies, enabling the team to efficiently meet study objectives
Regularly monitor and balance the workload of direct reports, ensuring fair distribution and manageable assignments
Oversee the development and performance management of direct reports, guiding them toward continuous growth and success
Ensure all direct reports have individual development and training plans in line with the Individual Development Plan (IDP) process
Provide regular coaching and mentorship, arranging external coaching support when necessary to promote professional development
Prepare salary and bonus proposals for direct reports in close consultation with the (Senior) Director, Country Head, and local HR Business Partner, ensuring decisions reflect individual performance
Collaborate closely with the responsible (Senior) Director, Country Head to support the effective functioning of the SMM organization at the country level
Contribute expertise to high-quality feasibility assessments, supporting appropriate site and study selection
Support the achievement of country-level SMM study delivery targets, ensuring studies are delivered to plan with both speed and quality
Drive quality improvement of study processes and procedures, championing best practices and continuous enhancement
Maintain all required systems in an up-to-date state to support efficient and compliant study conduct
Ensure the electronic Trial Master File (eTMF) is kept complete, accurate, and 'Inspection Ready'
Provide direction and support to CRAs and CSAs on major study deliverables and proactively resolve key issues
Ensure that all study activities at the country level are aligned with local policies, regulations, and the company code of ethics
Review monitoring visit reports, as applicable for direct reports, and in line with AstraZeneca Standard Operating Procedures (SOPs)
Review and evaluate accompanied/co-monitoring, training, and Quality Control visits performed by direct reports, in accordance with local QC plans
Perform accompanied site visits for quality assessment, ongoing coaching/development, and/or competency assessment of the team
Maintain open and effective communication with Functional Service Providers (FSPs), offering direction and feedback on both insourced and outsourced work

Qualification

Clinical ResearchClinical Study ManagementSite MonitoringDrug Development ProcessGxP ProcessesICH-GCPPharmaceutical Industry KnowledgeMedical KnowledgeData ManagementRisk-Based ThinkingRecruitment and Retention PlanningCoachingProject Management

Required

Bachelor's degree in related discipline, preferably in life science, or equivalent qualification aligned to the knowledge and skills of the role and ensures successful conduct of responsibilities and appropriate interactions with internal and or external stakeholders
7+ years of industry experience and 4+ years of site monitoring experience
Previous experience in the pharmaceutical industry, preferably in Clinical Operations (CRA / SrCRA / LSAD) or other related fields
Relevant knowledge and ability to fulfill key responsibilities, including but not limited to: Drug development process and related GxP processes, International guidelines ICH-GCP, relevant country regulations, medical knowledge and ability to learn relevant AZ Therapeutic Areas, Clinical Study Management including project management, monitoring, study drug handling and data management
Personal Effectiveness & Drives Accountability in Others
Learning Agility
Financial, Technology & Process Competency
Active Listening, Fluency in written & spoken business-level English
Act with Integrity & high ethical standards
Effectively lead a team across in-person and virtual settings to deliver shared goals, demonstrates cultural awareness
Identify and champion more efficient delivery of quality clinical trials with optimized cost and time
Ability to travel nationally/internationally as required
Valid driving license if country employment requirement
Communication & Teamwork - Influencing, Collaboration, Impactful Site conversations
Effective risk-based thinking – Plans & Aligns, Problem Solving, Critical Thinking, Decision Making, Effective Issue Management
Deliver Priorities Results & Impact - Recruitment/Retention Planning & Action, Ensures Accountability, Empowerment & Delegation
Leadership - Feedforward & Coaching, Drives Engagement & Development, Building Effective Teams, Manages Conflict

Benefits

Short-term incentive bonus opportunity
Equity-based long-term incentive program (salaried roles)
Retirement contribution (hourly roles)
Commission payment eligibility (sales roles)
Qualified retirement program [401(k) plan]
Paid vacation and holidays
Paid leaves
Health benefits including medical, prescription drug, dental, and vision coverage

Company

AstraZeneca

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AstraZeneca is a pharmaceutical company that discovers, develops, manufactures, and markets prescription medicines. It is a sub-organization of Investor.

Funding

Current Stage
Public Company
Total Funding
$7.26B
2026-02-25Post Ipo Debt· $2B
2024-07-30Post Ipo Debt· $1.51B
2023-02-28Post Ipo Debt· $2.25B

Leadership Team

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Pascal Soriot
Executive Director and Chief Executive Officer
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Aradhana Sarin
Group CFO and Executive Director
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Company data provided by crunchbase