Associate Director Process and Analytical Development, Global Program Management

Poseida is seeking an outstanding Project Manager to join our team. The Project Manager is a key member of the team and will partner with internal team leaders and external partners to develop, track, and implement various technical projects to support our therapeutic programs. The ideal candidate will identify, implement, and organize programs across cross-functional teams. The Project Manager will collaborate with teams to develop program strategy and timelines through completion.

Responsibilities
These may include but are not limited to:

PROGRAM MANAGEMENT:

  • Background in biologics and/or immune oncology
  • Work with cross functional teams to evaluate opportunities, analyze the scope, and supported endorsed projects
  • Assist teams in evaluating projects, prior to initiation, to ensure they contribute to pre-identified organizational variables
  • Maintain a systematic structure that drives project visibility to senior leadership through defined PMO methodology
  • Assists the team with determining the prioritization of opportunities based on critical business needs and defined organizational strategy plan
  • Provides a proactive approach to driving projects and identifying areas for risk mitigation
  • Creates, maintains, optimizes and publishes program dashboards on routine intervals

PROJECT MANAGEMENT:

  • Coordinate and facilitate projects that are cross functional/organizational to drive actions and decision making
  • Must have strong interpersonal skills capable of working with a diverse group of people
  • Identify and help manage risks, conflicts and barriers to enable project success
  • Incorporate project management tools that drive scope focus, team accountability, deliverables, timelines, implementation, and effectiveness checks
  • Directly manage projects with minimal supervision
  • Identify deliverables and inter-dependencies associated with projects
  • Routinely challenge the status quo to drive optimization and efficiencies
  • Identify and engage appropriate stakeholders to establish well-rounded and represented project teams, including but not limited to Technical Operations, Clinical Operations, Quality, Regulatory, Finance, and Research and Development
  • Incorporate financial and resource allocation aspects into project plans
  • Identify project and resource gaps to facilitate resolution(s)
  • Assist in representing Technical Operations with external partners vendors, including contract development
  • Ensure team decisions are clearly communicated and act as a single point of contact for project related information
  • Responsible for leading high impact activities across functional initiatives

Requirements, Knowledge, Skills and Abilities

  • Must have a minimum of 10 years of multi-disciplinary experience within pharmaceutical or biotechnology industry with at least 5 years project management experience (an equivalent of education and experience may be considered)
  • In-depth knowledge and experience in pharmaceutical clinical and commercial applications
  • Experience managing Industry and regulatory submission enabling projects (IND, BLA, etc.)
  • Strong proficiency with project management practices, tools and methodology including Gantt Charts, MS Project and Power Point
  • Complex Problem-solving abilities with focus on accomplishing company goals and objectives in a dynamic business environment
  • Outstanding written and oral communication and negotiation skills are essential
  • Strong leader with focus and drive to succeed—confidence, passion, results oriented and high energy
  • Ability to present thoughts clearly and concisely to a wide variety of stakeholders including senior management, directors, and corporate partners
  • Must have a BS/BA degree; higher education degree preferred (MBA, MBS, PHD)
  • Knowledge of Project Management Professional (PMP) applications preferred
  • Knowledge and experience in Gene and/or cell therapy, Assay development, Process Characterization, Validation, Qualification
  • Knowledge of CMC requirements and regulatory submissions preferred
  • Travel can be anticipated up to ~20%

Who We Are and What We Do

Poseida is a San Diego based biotechnology leader in the development of cell and gene therapies.  We have built a wholly-owned pipeline of autologous and allogeneic chimeric antigen receptor T cell, or CAR-T, product candidates, initially focused on the treatment of hematological malignancies and solid tumors. Here at Poseida we are constantly innovating and growing as we advance our CAR-T therapies in the clinic and our gene therapies currently under development.  The Poseida team is passionate about the impact we are making in developing treatments, or even cures, for patients with cancer or other genetic diseases.

The company’s CAR-T product candidates are manufactured with Poseida’s non-viral piggyBac® DNA Modification System, resulting in a high percentage of stem cell memory T cells (TSCM). Tscm cells are the only T cells that are self-renewing and long-lived, potentially resulting in product candidates that are more efficacious, less toxic and more durable. Poseida is currently developing the following CAR-T product candidates:

  • P-BCMA-101 is an autologous CAR-T therapy for the treatment of relapsed/refractory multiple myeloma, currently enrolling patients for a Phase 2 registrational trial with initial dosing expected in the first half of 2019.
  • P-PSMA-101 is an autologous CAR-T product candidate targeting PSMA-specific cancer cells in castrate resistant prostate cancer, with filing of an IND anticipated in the second half of 2019.
  • P-BCMA-ALLO1 is an allogeneic, or universal donor, CAR-T product candidate, manufactured using Poseida’s proprietary Cas-CLOVER™ site specific gene editing system and is being developed as a treatment for relapsed/refractory multiple myeloma, with an IND filing anticipated by late 2019 or early 2020.
  • P-MUC1C-101 is an autologous CAR-T product candidate in late-stage preclinical development for numerous solid tumor indications, including ovarian, breast, lung, colorectal, pancreatic and renal cancers, with filing of an IND anticipated in 2020.

Poseida plans to broadly advance its current CAR-T programs and emerging pipeline programs, including gene therapies for orphan genetic diseases.

To apply send your resume and cover letter to jobs@poseida.com.