Associate Director - Clinical Study Planning & Capacity Management - Navy Yard

Adaptimmune

Philadelphia, PA, US
  • Job Type: Full-Time
  • Function: Clinical Research
  • Post Date: 04/12/2021
  • Website: adaptimmune.com
  • Company Address: 351 Rouse Boulevard , Philadelphia, PA , 19112

About Adaptimmune

Adaptimmune, a leader in T-cell therapy, is a multinational, clinical-stage biopharmaceutical company focused on developing novel immunotherapies using its proprietary SPEAR T-cell receptor platform to treat solid tumors, which has the potential to transform the treatment of cancer.

Job Description

This new role in Clinical Development will partner closely with Project Manager, Product Clinical Lead and other Functional leads (eg DM, Legal) to drive cross functional planning and effective execution of Clinical Studies through the development of realistic study-level timelines and objective communication of project status.

In addition, this role will support Clinical Development Functional Heads in Resource Capacity Management, to ensure optimized planning and reporting of resource and budgets associated with Clinical Trial Study Execution to ensure they stay on track in terms of time, cost, and quality.

Key Responsibilities

1.

  • Maintain and manages Key Milestones Report to provide an overview of current Clinical Study operational assumptions (Pts, Sites, Timelines)
  • Maintain and communicate progress against study-level timelines for all downstream reporting needs and proactively make key stakeholders aware of issues arising
  • Support development and deployment of financial Change Control process for Clinical Trial Study Budgets including off-cycle & periodic budget updates
  • Maintains and develops, recommending improvements where appropriate tostandard Study Timelines by phase/study type informed by Industry Standards & Best Practices as well as historic Adaptimmune performance
  • Track Study Cycle times and identifies opportunities for improvement and makes necessary recommendations and then driving any approved changes through to completion.
  • Oversee Trial Resource forecasting & capacity management (including supporting deployment of potential future technology solution)
  • CMC Vector & Capacity Forecasting

2. Support Clinical Development as required on initiatives regarding Process Optimization & Innovation opportunities from reviewing current practices through to recommending future improvements

Qualifications & Experience

Required

  • Minimum of Bachelor’s degree in Science or Business discipline or qualified by experience
  • Previous experience in a matrix environment
  • Relevant clinical experience in pharmaceutical, CRO, or biotechnology company including proven experience
    • Study Timeline and/or Budget Management or related Project Management experience
    • Development and monitoring of metrics & KPIs
  • Knowledge of ICH/GCP and FDA regulations

Skills & Compentencies

Required

  • Highly motivated, independent, and a self-starter
  • Strong interpersonal skills and communication skills (both spoken and written).
  • Ability to collaborate effectively with study execution teams, cross-functional team members/ leaders, and external partners
  • Self-motivated, adaptable to a dynamic environment
  • Excellent planning, organization and problem solving abilities
  • Experience with MS Project or other Project Management Tools
  • Excellent computer skills
  • Ability to navigate and manage stakeholders in a matrix environment

decision making authority

  • Financial sign off accountability- as per company policy
  • Operational management decisions as directed by manager

other requirements

  • Global travel - ability to travel internationally, when required
  • Valid driver's license
     

At Adaptimmune we embrace diversity and equality of opportunity. We believe that the more inclusive we are, the better our work will be. We welcome applications to join our team from all qualified candidates, regardless of age, colour, disability, marital status, national origin, race, religion, gender, sexual orientation, gender identity, veteran status or other legally protected category. It is our intent that all qualified applicants will receive equal consideration for employment.

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Disclaimer: Local Candidates Only
This company does NOT accept candidates from outside recruiting firms. Agency contacts are not welcome.