Head US External Scientific Research

AstraZeneca   •  

Gaithersburg, MD

Industry: Pharmaceuticals & Biotech


11 - 15 years

Posted 30 days ago

This job is no longer available.

At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the utmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people's exceptional skills with those of people from all over the globe. As Head US External Scientific Research , you will play a pivotal role in channeling our scientific capabilities to make a positive impact on changing practice and patients' lives.

AstraZeneca's vision in Oncology is to help patients by redefining the cancer-treatment paradigm, with the aim of bringing six new cancer medicines to patients between 2013 and 2020. A broad pipeline of next-generation medicines is focused principally on four disease areas - breast, ovarian, lung and hematological cancers. As well as other tumor types, these are being targeted through five key platforms - immunotherapy, the genetic drivers of cancer and resistance, DNA damage repair, HER2 and antibody drug conjugates, underpinned by personalized healthcare and biomarker technologies.

Position Description

  • Accountable for leading and line management of 10 - 15 member team of ESR Managers, Specialists and Alliance Director with direct reports
  • Oversight and delivery of Externally Sponsored and Collaborative Research (Investigator Sponsored Studies) according to agreed resources, budget and timelines.
  • Lead the recruitment, retention, and development of the team to build capabilities and innovation that positions AstraZeneca as a Partner of Choice in External Scientific Research.
  • Ensuring effective resourcing of projects across the oncology portfolio.
  • Development and performance management of the team(s) or direct reports.
  • Contribute to staff productivity and efficiency measures, contribute to the quality improvement of the ESR governance processes and other procedures.
  • Plan and organize coaching of the team members and all direct reports.
  • Ensure that the individual performance planning and review process is completed for all direct reports, including preparing salary and bonus proposals of all team members or direct reports based on their performance
  • Provides guidance to ESR managers on issues related to process and compliance.

Major responsibilities

  • The Sr. Director, External Scientific Research has primary responsibility for the oversight and management of Externally Sponsored and Collaborative Research programs across Oncology in AstraZeneca. This individual will support all Medical Teams, Brand Teams, Medical Affairs, and/or other cross functional units within AstraZeneca that review and approve research proposals from external investigators and institutions.
  • Through oversight of the team ESR Managers, the Sr. Director ensures the timely review of all of ESR proposals and protocols, contract generation and execution, and forecasts and coordinates drug shipments across all programs. The role also is accountable for study progress and collaborates with stakeholders to ultimately ensure compliance with all processes, systems and regulations.
  • The incumbent holds the team of ESR Managers accountable for liaising externally with Principal Investigators, research sites, co-op groups, relevant government agencies (e.g., NIH, NCI), drug safety monitoring boards, alliance partners, and suppliers.
  • The incumbent also ensures the ESR related systems and educational needs of internal and external stakeholders maintained in compliance with AstraZeneca's ESR policies and guidelines as well as external healthcare law throughout the process. The Sr. Director, will champion operational excellence to provide continuous improvement of processes and sharing of best practices and participates in efforts to improve ESR functions globally across an asset program.
  • The Sr. Director will support strategic contract negotiations to maximize opportunities and ensure delivery to quality and standards.

Additional Responsibilities

  • Act as an ambassador for ESR, providing clarity on the roles and delivering appropriate advocacy whenever possible to ensure company-wide understanding and compliance
  • Provide training for internal stakeholders such as Medical and Field Team.
  • Assist department senior leaders in efficient functioning of the department at country level.
  • Liaise with Local Compliance Officer to ensure processes are in accordance with local requirements.
  • Ensure that ESR concepts and proposal review and completion of study milestones are performed to highest quality.
  • Keep track on research intelligence and best practices in local markets.
  • Support senior leaders in initiatives/activities as agreed within the department.

Minimum Requirements and Preferred Background

  • Minimum University degree and / or equivalent, preferred in biological science or healthcare-related field.
  • Minimum 10 years experience in Clinical Operations or other related fields (Medical Affairs-led studies or Academic-led studies).
  • Excellent knowledge of spoken and written English.
  • Good ability to learn and to adapt to work with IT systems.

Functional skills

  • Excellent knowledge of relevant AstraZeneca Procedural Documents.
  • Excellent knowledge of international guidelines - ICH/GCP.
  • Good knowledge of relevant local regulations.
  • Good medical knowledge in relevant AstraZeneca Therapeutic Areas.
  • Good understanding of the Drug Development Process.
  • Good knowledge in Clinical Operations.
  • Excellent understanding of the Clinical Study Process.
  • Excellent knowledge/experience of the Monitoring Process.
  • Good understanding of the Study Drug Handling Process.
  • Good understanding of the Data Management Process.

Management Skills

  • Resource management skills.
  • Good financial management skills.
  • Good decision-making skills.
  • Excellent project management skills.
  • Excellent team building skills.
  • Excellent interpersonal skills.
  • Strong analytical skills.
  • Excellent communication skills, verbal and written.
  • Excellent presentation skills.
  • Ability to prioritize and handle multiple tasks.
  • Excellent ability to have attention to details.
  • Good ability in working according to global standards.