Project Manager 2018-02-10T00:07:47+00:00

Senior Manager, Project Manager

Job Summary

Reporting to Chief Scientific Officer, the Sr. Manager of Project Management (PM) has responsibility for executing on pre-clinical and clinical strategies to deliver successful filing of INDs and execution of early clinical trials. The project manager is responsible for developing project plans and budgets for pre-clinical IND enabling studies that are used to obtain a US IND for Cyteir’s lead RAD51 inhibitor program, for qualifying studies required for companion diagnostics, and for clinical trials. The PM will be responsible for tracking the execution and spending according to the plans. He/She will work closely with the project team to assure timely execution according to plan within the given time and budget. The PM will possess a solid understanding of all aspects of drug development, including US and international government guidelines/regulations and the drug approval process. A successful PM will have deep expertise in the IND process and more of a working familiarity with other areas. The PM will be involved in leading the Rad51i program which includes both drug and diagnostic preclinical and clinical development strategies.

Job Responsibilities

Key tasks for the Sr Manager of Project Management:

  • Manage projects of varying complexity with supervision from the CSO
  • Establish and maintain high level timelines and detailed timelines with input from the functional leaders and consultants.
  • Establish timelines and budgets for all IND enabling studies and all companion diagnostic studies
  • Lead/assist the evaluation, selection and management of Contract Research Organizations (CROs) and other external vendors to ensure successful IND filing and clinical trial implementation and execution
  • Manages study operational plan and CRO activities, including project timelines and quality of deliverables and managing approved trial budget(s) throughout the life of the project
  • Maintains frequent and meaningful contact with CROs to assess performance and provide guidance as needed
  • Track various parts of the timeline and escalate issues to senior management, participate in resolutions, update timelines on an on-going basis to allow transparency to corporate leadership
  • Assure that timelines are met and that studies stay on budget
  • Establish deliverables for all team members, and assure delivery on time
  • Establish development plans and keep them updated on a regular basis
  • Partner with CMC to provide drug supply assumptions and contribute to design and packaging of supplies for IND enabling studies and clinical trials
  • Prepare monthly progress reports as required
  • Implement best practices for tracking of projects
  • Develop templates, dashboards, and processes for project management
  • Effectively manage conflicts and negotiations
  • Lead the communication of the product strategy to the Cyteir Executive Committee which will include presenting/defending key development strategies and providing regular program updates
  • Ensure that the tactical plan supports all elements of the product development plan and includes a detailed timeline and budget
  • Liaise with key scientific and medical investigators as appropriate
  • Lead the budget development and review activities and ensure all activities (upside and down side) are accounted for and assumptions are documented

Qualifications

  • Strong organizational, analytical, communication, and negotiation skills
  • Demonstrated ability to multi-task, prioritize effectively and creatively, exhibit flexibility in a changing environment and communicate effectively with a multi-site team
  • Proficient with project tracking tools, e.g. Microsoft Project and Excel and presentation tools, e.g. PowerPoint
  • Education and Experience
  • Bachelor’s degree or MS in scientific or healthcare discipline
  • Minimum 5 years of pharmaceutical/biotech experience/3 years Project Management experience or equivalent in pre-clinical development and/or clinical research & development; PMP certification desirable.
  • Excellent project management skills and results driven
  • Experience negotiating vendor/site contracts and managing budgets
  • Solid vendor management skills (CROs, laboratory and clinical supply logistics)
  • Ability to interface with medical personnel at clinical sites
  • Understanding of drug development from pre-IND through NDA
  • Thorough understanding of FDA, ICH and GCP guidelines
  • Demonstrate excellent communication skills and cross-functional collaboration skills
  • Effectively utilizes information technology systems and project management tools including systems (MS project, Microsoft Visio, Excel)
  • Possesses a global understanding of the drug development process, πincluding clinical operations, and a cross-cultural awareness
  • Ability to effectively manage conflicts and negotiations while providing impact and influence
  • Excellent organizational, analytical, and planning skills
  • Knowledge of diagnostic development and/or oncology, a plus
  • Strong influencing skills, ability to build consensus within multi-functional teams and strong critical thinking and issue resolution skills
  • Understanding of drug manufacturing principles and regulatory practices in major markets
  • Ability to interpret scientific data and understand the implications for clinical and diagnostic drug development
  • Strong communication skills and experience in presenting and developing presentation materials to corporate management and BODs
  • Strong knowledge of project management practices and best business practices for working within a multi-functional pharma environment
  • Working Conditions

This is an office-based position with 10% travel expected.

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SENIOR MANAGER, PROJECT MANAGER

  • Reports To: CSO
  • Department: Research
  • Status: Exempt
  • Job Location: Cambridge, MA
  • Base: Office
  • Management Level: Individual Contributor
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