Associate Director / Director, Program Management

Location
Philadelphia, PA, United States
Posted
Feb 22, 2021
Ref
2421696766
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 Director, Program Management will facilitate, manage, and execute therapeutic development for Century's novel iPSC-derived, targeted allogeneic NK and T cell therapies. S/he will serve as an expert to guide cross-functional teams to successfully progress Century's hematology and oncology pipeline projects, timelines, and budgets, in collaboration with functional leads. S/he will lead the project management office (PMO) for Century, defining required staffing, capabilities, and tools. S/he will ensure project management, portfolio, and governance excellence for Century.

Responsibilities:
  • Expertly manages 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. Defines program strategy along with functional area leads
  • Strategic leadership, defining options for programs via scenario analysis; drives decision making, considering impact to timelines, resources, and budget
  • Facilitates IND-enabling and clinical Phase I/II-enabling activities, including regulatory, clinical, clinical operations, translational, and other cross functional activities. May facilitate advisory boards.
  • Independently leads subteams
  • Leads project management office (PMO), including:
  • -Defining required staffing, capabilities, and tools
  • -Hiring and directly managing and providing mentorship to the group
  • -Recommending and implementing project and portfolio management capabilities
  • Expert application of project management
  • -Develops, owns, and manages timelines and team tools, resources and budget planning
  • -Identifies project risks and issues; works with functional experts to mitigate and resolve
  • challenges and issues
  • -Ensures effective, accurate, and timely communication
  • Directly manages alliance programs and serve as point of contact with partners
  • Ensures that all activities comply with company SOPs, GxPs, and any regional specific regulations
  • Cultural Steward: Fosters values including integrity, trust, passion for science and for patients, and inclusiveness. Mentor for high performing teams directly and cross-functionally.


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; through registration desirable
  • 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
  • Demonstrated alliance management or collaboration experience
  • Top-tier 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).
  • +15 years of relevant biopharmaceutical experience.
  • A minimum of 8 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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