Associate Director / Director, Program Management

Location
Philadelphia, PA, United States
Posted
Jan 23, 2021
Ref
2377807866
Hotbed
Pharm Country
Required Education
Bachelors Degree
Position Type
Full time

Position Title: Associate Director / Director, Program Management

Position Level: Associate Director / Director, Program Management

Reports to: Chief Development Officer

Department Name: Early Development

Company Background:

Century Therapeutics is developing novel allogeneic living cell products for oncology that overcome the limitations of current cell therapies. Century's genetically-engineered, universal iPSC-derived immune effector cell products are designed to specifically target hematologic and solid tumor cancers. Our commitment to developing off-the-shelf cell therapies will expand patient access and provide an unparalleled opportunity to advance the course of cancer care.

Century's foundational technology is built on induced pluripotent stem cells (iPSCs) that have unlimited self-renewing capacity. This enables complex cellular engineering to produce controlled cell banks of modified cells that can be expanded and differentiated into desired immune effector cells, which can supply vast amounts of allogeneic, homogeneous therapeutic products. This platform differentiates Century from other approaches that utilize non-renewable donor-derived cells.

Role:

Reporting to the Chief Development Officer, the Project Manager will facilitate, manage, and execute therapeutic development for Century's novel iPSC-derived, targeted allogeneic NK and T cell therapies. S/he will guide cross-functional teams for Century's pipeline to successfully progress hematology and oncology projects, timelines, and budgets, in collaboration with functional leads. S/he will be a driver of project management, portfolio, and governance excellence for Century.

Responsibilities:

 

  • Drive and manage allogeneic iPSC-derived targeted cell therapy therapeutic development projects in hematology and oncology, from preclinical development through clinical proof of concept, in collaboration with cross-functional project teams
  • Facilitate IND-enabling & clinical Phase I/II-enabling activities, including regulatory and clinical operations activities
  • Strategic leadership to analyze scenarios and define options for programs
  • Along with functional leads, drive program strategy and decision making, considering impact to timelines, resources, budget
  • Independently lead subteams
  • Develop, own, and manage timelines and team tools
  • Identify project risks and issues; work with functional experts to mitigate and resolve
  • Develop and coordinate resource and budget planning
  • Prepare agendas, minutes, progress reports
  • Ensure effective, accurate, and timely communication
  • Ensure high-performing teams
  • May directly manage alliance programs and serve as point of contact with partners
  • Ensure that all activities comply with company SOPs, GxPs, and any regional specific regulations
  • Define, recommend, and implement project management operational needs

 


Requirements:

 

 

  • Direct project management experience in a therapeutic drug development setting in hematology or oncology disease areas
  • Project management experience from IND-enabling phase to Phase I/II clinical studies
  • Experience in cell therapies, gene therapy, biologics, or vaccine development
  • Familiarity with regulatory requirements (e.g., FDA regulations, and ICH /GxP guidelines), technical (CMC) requirements, and clinical study execution
  • Alliance management or collaboration experience desired
  • Excellent project management, communication, and cross-functional collaboration skills, with a results-driven mindset
  • Proven ability to effectively manage conflicts and negotiations while providing impact and influence
  • Excellent organizational, analytical, and planning skills
  • Robust proficiency in project management and collaboration support tools and systems
  • PMP certification

 


Qualifications:

 

 

  • Bachelor's degree in science or engineering required. Advanced degree required (MS, MBA, PharmD, or PhD).
  • +10 years of relevant biopharmaceutical experience.
  • A minimum of 6 years project management in a cross-functional drug development or team role required.

 


Location:

This role will be located in Philadelphia, PA or Seattle, WA and requires the ability to travel domestically and internationally (~10%)

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