Senior Director, Clinical Operations Strategic Enablement R&I

AstraZenecaBoston, MA
7d$233,586 - $350,380Hybrid

About The Position

The Senior Director, Clinical Operations Strategic Enablement will lead the design, build, innovation and continuous improvement of clinical operations capabilities to support the delivery of clinical development programs in the R&I and V&I Therapeutic Area. They will partner cross-functionally within Clinical Operations, Clinical Development, Medical Affairs, Commercial, other aligned internal functions and external partners to lead the collation of data insights to support clinical trial design in new disease areas and strengthen investigator/site identification and engagement. Working with R&I and V&I TA strategy, the role will support identification and connection of data sources to champion data driven, patient-centric practices that improve trial design, performance, study start‑up, recruitment, and data quality. This global role provides deep understanding of historical trends, industry benchmarks and cycle times to drive acceleration, innovative approaches, inform planning, portfolio oversight and performance management, including milestone tracking, KPI development and monitoring. This senior leader brings extensive clinical operations portfolio leadership, strong stakeholder collaboration and strategic thinking to drive innovative, effective trial design and delivery for R&I indications. Accountabilities Planning, Governance and Analytics: Collating historical trends, industry benchmarks and cycle times to define KPIs and identify opportunities for improved performance, innovation and continuous improvement Partner in development of data standards, metrics and dashboards to facilitate use of information providing business insights and informed decision making relating to trial design and execution to support clinical operations leadership/department Support long-range planning through provision of Clinical Operations data insights and metrics during Therapeutic Area (TA) strategy, Medium-Term Plan (MTP), and Long-Term Plan (LTP), embedding operational considerations and feasibility insights into strategic decision-making for new and emerging indications Facilitate discussions in monthly resource reviews and performance insights on clinical portfolio Identify opportunities to leverage technology, AI and automation and support adoption across the R&I Clinical Operations department Align and share data insights and expertise cross-functionally TA Strategy: Collate insights to inform study design and delivery team planning considering specific therapy area standards of care, regulations and advancements in practice Define the vision, and roadmap for building R&I clinical operations capabilities to support new and established indications, innovative trial design and technologies Partner in oversight of the work of Clinical Trial Liaisons and Clinical Trial Educators (if utilized), setting priorities, providing coaching, and monitoring performance to ensure consistent, high-quality execution Disease area and site network development: Lead set-up and execute a comprehensive investigator engagement strategy for new and established R&I indications covering scientific exchange, operational enablement, performance feedback, recognition and long-term partnership models Support cross-functionally in development of high-performing, diverse global investigator and site networks to deliver development programs in new and established R&I indications Ensure aligned engagement across SMM, Clinical Development, Medical Affairs, and Commercial and ensure consistent messaging across these groups on R&I portfolio priorities Coordinate Therapeutic Area R&D-focused congress activities, including planning, content alignment, stakeholder preparation, and post-congress follow‑up to translate insights into operational actions

Requirements

  • Scientific/technical (e.g. BS, MS) or PhD, PharmD)
  • 10+ years' experience in drug development, clinical trial conduct, clinical operations, and site level interactions including experience in clinical development (pharmaceutical industry, CRO, or academia)
  • Portfolio leadership experience across early and late phase stages and change management
  • Proven experience in data analysis and depth of knowledge in clinical operations data insights
  • Experienced in project and budget management technologies and process
  • Proven ability to develop successful collaborations with internal stakeholders and external partners
  • Excellent communication skills and stakeholder management
  • Ability to influence in a matrixed, ambiguous environment
  • Strong strategic influencing skills, innovative, and adept at effectively solving complex problems.
  • Knowledge and experience to work across projects, with a fast-learning curve when moving into new disease areas
  • Proven track record of self-management, planning, prioritization, and delivery success
  • Ability to develop and maintain strong customer and business partner relationships
  • Flexibility to work in a fast-paced and constantly changing environment
  • Demonstrated leadership qualities with focus on collaborative working skills, prioritization, trust, and openness – irrespective of cultural setting
  • Proven teamwork and collaboration skills
  • Demonstrates AstraZeneca Values and Behaviors

Nice To Haves

  • Experience in either respiratory or allergy/immunology/autoimmune diseases
  • Experience in matrix team environment with interplay between clinical, operations, commercial, drug safety and regulatory
  • Experience of working with external specialty providers, clinical sites, and patient advocates
  • Experience of working as part of a clinical trial team within a clinical site
  • Knowledge and capability with digital solutions/tools

Responsibilities

  • Collating historical trends, industry benchmarks and cycle times to define KPIs and identify opportunities for improved performance, innovation and continuous improvement
  • Partner in development of data standards, metrics and dashboards to facilitate use of information providing business insights and informed decision making relating to trial design and execution to support clinical operations leadership/department
  • Support long-range planning through provision of Clinical Operations data insights and metrics during Therapeutic Area (TA) strategy, Medium-Term Plan (MTP), and Long-Term Plan (LTP), embedding operational considerations and feasibility insights into strategic decision-making for new and emerging indications
  • Facilitate discussions in monthly resource reviews and performance insights on clinical portfolio
  • Identify opportunities to leverage technology, AI and automation and support adoption across the R&I Clinical Operations department
  • Align and share data insights and expertise cross-functionally
  • Collate insights to inform study design and delivery team planning considering specific therapy area standards of care, regulations and advancements in practice
  • Define the vision, and roadmap for building R&I clinical operations capabilities to support new and established indications, innovative trial design and technologies
  • Partner in oversight of the work of Clinical Trial Liaisons and Clinical Trial Educators (if utilized), setting priorities, providing coaching, and monitoring performance to ensure consistent, high-quality execution
  • Lead set-up and execute a comprehensive investigator engagement strategy for new and established R&I indications covering scientific exchange, operational enablement, performance feedback, recognition and long-term partnership models
  • Support cross-functionally in development of high-performing, diverse global investigator and site networks to deliver development programs in new and established R&I indications
  • Ensure aligned engagement across SMM, Clinical Development, Medical Affairs, and Commercial and ensure consistent messaging across these groups on R&I portfolio priorities
  • Coordinate Therapeutic Area R&D-focused congress activities, including planning, content alignment, stakeholder preparation, and post-congress follow‑up to translate insights into operational actions

Benefits

  • qualified retirement programs
  • paid time off (i.e., vacation, holiday, and leaves)
  • health, dental, and vision coverage

Stand Out From the Crowd

Upload your resume and get instant feedback on how well it matches this job.

Upload and Match Resume

What This Job Offers

Job Type

Full-time

Career Level

Director

Education Level

Ph.D. or professional degree

Number of Employees

5,001-10,000 employees

© 2024 Teal Labs, Inc
Privacy PolicyTerms of Service