Project Management Director jobs in Annandale, VA

Project Management Director develops and directs project management operations and strategic planning to meet organizational goals. Provides overall strategic governance for projects by establishing standards, processes, and tools used for effective project delivery. Being a Project Management Director establishes methodologies to set productivity and quality targets and to assess results for all projects. Responds to escalated project issues that may impede project delivery and coordinates solutions. Additionally, Project Management Director monitors and analyzes project metrics to identify weaknesses or problems and to propose operational improvements and cost savings for future projects. Requires a bachelor's degree. May require a project management certification. Typically reports to top management. The Project Management Director manages a departmental sub-function within a broader departmental function. Creates functional strategies and specific objectives for the sub-function and develops budgets/policies/procedures to support the functional infrastructure. To be a Project Management Director typically requires 5+ years of managerial experience. Deep knowledge of the managed sub-function and solid knowledge of the overall departmental function. (Copyright 2024 Salary.com)

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Director- Cell Therapy Operations, Oncology R&D, Early Clinical
  • 50056698 - Assoc Director Sci Project Mgmt
  • Gaithersburg, MD FULL_TIME
  • The Director – Cell Therapy Operations has a sizeable scope, including accountability for the operational design inputs to deliver the assigned program(s) as part of the product development team. Within a program, they maintain accountability for the delivery and reporting of clinical studies to time, quality, and cost. The Director - Cell Therapy Operations is a key member of the Global Project Team. This position demands strong collaborative communication skills, including the ability to engage with and influence a diverse range of stakeholders both within and outside of AstraZeneca.

    The Director – Cell Therapy Operations is responsible for the design and implementation of a logistics model ensuring effective scheduling of patients and their cells (apheresis & final drug product) between investigating/treatment sites and the manufacturing facility. They will develop the tools and processes to ensure smooth execution of each step of the patient journey once the patient is either a) enrolled in a clinical trial or b) commercially when a patient is approved for treatment and beginning the treatment course.
     

    The exact accountabilities will differ depending on the stage of the clinical program, so a high degree of flexibility and autonomy is required.

    Typical Accountabilities:

    • Establish site qualification criteria and conduct operational certification for apheresis/treatment (e.g., FDA Risk Evaluation and Mitigation Strategy (REMS) qualification). Track and maintain site certification and recertification needs

    • Manage the operational setup of new apheresis and treatment centers; ensure site training (compliance versus needs / requirements)

    • Ensure investigators and site staff have a thorough understanding of processes for treatment execution (e.g., scheduling portal, apheresis and infusion procedures, cell handling, shipping, etc.)

    • Build relationships with clinical / commercial site operations personnel (e.g., cell therapy operations managers)

    • Collaborate between the Investigator Site, couriers, and internal functions at AstraZeneca, namely Manufacturing, Supply Chain, Clinical Operations and Medical/Clinical Science to ensure that patient visits and cell product delivery are coordinated

    • Lead patient scheduling and cell management tasks, from confirming apheresis and subsequent dispatch to manufacturing, coordinating courier pick-ups and deliveries, as well as preparation of shipping documentation, communicating product manufacturing milestones to Clinical Sites & coordinating patient visits preparation prior to infusion (chemotherapy conditioning)

    • Develop, maintain, and evaluate key performance indicators for patient treatment execution

    • Ensure appropriate infrastructure is in place to deliver the treatment, including working with development and commercial leadership to establish and implement an apheresis and treatment center network strategy

    • Accountable for overall study or program deliverables, maintaining oversight throughout the life of the study or program by close interaction with individual study/program leaders or leadership of the study team as appropriate

    • Use relevant tools and communication with clinical sites, optimize patient and drug scheduling, to optimize the number of patients recruited per site per month/year.

    • Develop and manage effective risk management/mitigation plans to ensure timely delivery to quality, budget and time and escalate issues to stakeholders as appropriate

    • Responsible for planning and leading issue escalation and resolution

    • Provide input to forecasting and management of study/program delivery costs, resource and timelines

    • Accountable for the quality of study/program planning information into relevant planning systems

    • Mentor and support development of individuals within the organization

    • Manage a team of schedulers responsible for scheduling, logistics and support of all AZ cell therapy trials worldwide

    • Contribute to operational interactions with external entities including regulatory agencies, preferred partners/suppliers and external collaborators

    • Responsible for study or program level reporting of progress, risks, and issues

    • Lead the study delivery related activities associated with regulatory inspections/audits in liaison with Clinical functions

    • Responsible for provision to procurement clear specifications for study or program-specific outsourcing

    • Responsible for review and operational approval of study or program specific contracts or work orders.
       

    Education, Qualifications, Skills, and Experience

    Essential :

    • Bachelor’s degree in related discipline, preferably in medical or biological science.

    • At least 10 years or equivalent experience in drug development leadership experience with progressive levels of responsibility.

    • Comprehensive knowledge of the clinical and pharmaceutical drug development process

    • Proven ability to develop programs to meet business goals and to assess business risk versus potential value; ability to understand global business requirements

    • Significant experience of program management and use of project management techniques in complex projects, including resourcing and financial management

    • Strong strategic influencing skills and ability to influence broadly within and outside the organisation

    • Significant experience and expertise in Clinical Trial methodology with a proven track record to deliver differentiated options based on a sound knowledge of operational delivery

    • Proven track record in problem solving and issues management that is solution focused

    • Extensive and proven experience in driving operational delivery to timelines, cost, and quality

    • Proven experience of leading delivery through collaboration with internal and external providers

    • Excellent knowledge of ICH-GCP principles

    • Experience in providing clear requirements for external contracts

    • Experience in selection and oversight of external providers and development/review of contracts
       

    Desirable:

    • Higher degree e.g., PhD, MSc, MPhil

    • Program management qualification (e.g., MBA, PRINCE2, PMP)

    • Experience in variety of academic/CRO/Sponsor organizations and countries

    • Experience across the product life cycle and multiple therapeutic areas

    • Experience of early phase clinical delivery

    • At least 5 years global drug development experience within clinical function

    • Salesforce or other customer management software systems

    AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

    AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.

  • 13 Days Ago

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Project Manager
  • Office of the Director of National Intelligence
  • Reston, VA FULL_TIME
  • The National Counterterrorism Center (NCTC) leads the nation's effort to protect the United States from terrorism by integrating, analyzing and sharing information to drive whole-of-government action ...
  • 9 Days Ago

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Associate Director Quality Control
  • 10000929 - Assoc Director Study Management
  • Rockville, MD FULL_TIME
  • Are you ready to take the lead in ensuring the hard work from the rest of the business is realized, as we reliably get every medicine out to patients without challenge? We are looking for an Associate...
  • 9 Days Ago

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Executive Project Coordinator
  • Office of the Director of National Intelligence
  • Bethesda, MD FULL_TIME
  • The mission of the National Counterintelligence & Security Center is to lead and support the U.S. Government's counterintelligence (CI) and security activities critical to protecting our nation; provi...
  • 10 Days Ago

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Project Management Intern| Health Affairs
  • Project HOPE
  • Washington, DC INTERN
  • Project Management Intern| Health Affairs, Health AffairsLocation: District of ColumbiaUnited States Project HOPE is an international NGO of more than 900 engaged employees and hundreds of volunteers ...
  • 25 Days Ago

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Director, Project Controls
  • Project Farma
  • Washington, DC FULL_TIME
  • Project Farma (PF) is the leading advanced therapy technical operations consulting company in the life science industry. We provide biomanufacturing strategy and execution to start up and established ...
  • 5 Days Ago

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0 Project Management Director jobs found in Annandale, VA area

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Contracts Executive Director
  • Dewberry
  • Fairfax, VA
  • Job Description: Dewberry is currently seeking a Contracts Executive Director to lead, manage, and enhance the companys ...
  • 3/28/2024 12:00:00 AM

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Vice President, Health Policy - Evaluation, Economics and Predictive Modeling - Remote
  • UnitedHealth Group
  • Falls Church, VA
  • $30,000 Sign-on Bonus for External Candidates Optum is a global organization that delivers care, aided by technology to ...
  • 3/28/2024 12:00:00 AM

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Project Manager, Site/Earth Work
  • Muller, Inc.
  • Reston, VA
  • Title: Project Manager, Site Work Division Type: Full time, exempt Location: Reston, Virginia Reports To: Director of Op...
  • 3/28/2024 12:00:00 AM

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Budget Analyst
  • Perikin Enterprises LLC
  • Washington, DC
  • Job Description Job Description PERIKIN Enterprises maintains a contract with the National Nuclear Security Administrati...
  • 3/27/2024 12:00:00 AM

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Student Trainee (Project Management)
  • Office of the Secretary of the Interior
  • Herndon, VA
  • Summary This position is part of the Interior Business Center (IBC), Financial Management Directorate (FMD), Project Man...
  • 3/25/2024 12:00:00 AM

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Education Project Manager (Remote Flexible)
  • Abt Global Inc.
  • Rockville, MD
  • **The World at Abt** Solving the worlds most pressing issues and improving the quality of life for people worldwide is w...
  • 3/25/2024 12:00:00 AM

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Building Automation Systems (BAS) Project Engineer II
  • Conquest Solutions, LLC
  • Greenbelt, MD
  • Job Description Job Description BAS Project Engineer II Conquest Solutions, LLC (CQS) is a leading application and engin...
  • 3/24/2024 12:00:00 AM

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Director and Division Counsel
  • General Dynamics Information Technology
  • Falls Church, VA
  • The Director & Division Counsel will provide legal and strategic support to the company's Federal Civilian division. Thi...
  • 3/24/2024 12:00:00 AM

Annandale is located at 38°50′3″N 77°12′41″W / 38.83417°N 77.21139°W / 38.83417; -77.21139 (38.834134, −77.211277). Annandale is mostly traversed by the Capital Beltway and Virginia State Route 236. The center of town is considered to be where Route 236, Columbia Pike, and Backlick Road meet around two miles (3 km) east of Interstate 495 on Route 236. According to the United States Census Bureau, the CDP has a total area of 7.86 square miles (20.4 km2), all of it land. The area is part of the coastal plain located just east of the Fall Line separating the coastal plain of Virginia from the ...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Project Management Director jobs
$187,919 to $239,718
Annandale, Virginia area prices
were up 1.3% from a year ago

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