Associate Director/ Director, CMC Program Management

Location
Gaithersburg, MD
Posted
Nov 16, 2020
Required Education
Bachelors Degree
Position Type
Full time

ABOUT ARCELLX:  Arcellx (http://www.arcellx.com/) is a clinical-stage biopharmaceutical company developing adaptive and controllable cell therapies for the treatment of patients with cancer and autoimmune diseases.  The Arcellx vision is to utilize our novel proprietary platform to bring superior cell therapies to more patients through the care of academic and community practices worldwide.

PRIMARY OBJECTIVE:  The candidate will bring expertise in CMC program management, cell therapy drug development and an excellent track record of CMO oversight/alliance management to lead the CMC program management function.  Primary responsibilities include partnering and strategizing with the VP of Protein Sciences, VP of Cell Sciences and Director of Vector Sciences to support process development activities, technology transfer to CMOs and clinical manufacturing sites, and ensuring clinical supply for the early and late stage portfolio.  Additionally, he/she will work with supply chain, Clinical Operations, and CMOs to ensure delivery of material to the clinical sites according to cross-functional program team plans.   His/her functions will include but are not limited to supporting internal CMC functions (Protein, Vector, and Cell Sciences), oversight of outsourced CMC activities at CMOs and clinical sites, development of detailed CMC plans by program, and shaping further development of the CMC program management function.

MAIN ACCOUNTABILITY:

  • CMC Program Management Group leadership.  
  • Form strong strategic partnerships with the VP of Cell and VP of Protein Sciences, acting as the hub of CMC program, CMC operational, and CMC portfolio information.
  • Proactive engagement of key stakeholders/team members within CMC and interfacing departments (Clinical, Program Management, Regulatory, Quality, Ops) to deliver CMC milestones.
  • Generate Gantt charts/swimmer plots/visualizations, detailed plans on MS Project, and effective budget management for protein, cell and vector activities, integrating multiple CMO’s activities into plans.
  • Establish regularly scheduled meetings with core CMC team members to review detailed product delivery timelines, process development work, resolve issues/roadblocks, and perform scenario planning – holding ad-hoc meetings to deliver key information to the project team as needed.
  • Serve as the point of contact for CMOs’ Program Management/Client Delivery counterparts and assist CMC teams in tracking and following up on internal and CMO action items.
  • Core member of the cross-functional Program Teams, responsible for providing strategic CMC insight, internal and external CMC activity timeline updates, flagging risks and scenario-planning solutions to have at the ready if risks occur.
  • Provide strategic, tactical and operational input to CMC teams.
  • Translate project milestones into CMC development goals and measurable objectives for the CMC teams and drive optimal delivery.

PREFERRED QUALIFICATIONS:

  • Bachelor’s degree + 10 years industry experience, Master’s Degree or PhD (preferred) + 7 years industry experience
  • PMP certification (preferred)
  • 5+ years of experience in cell therapy CMC program management overseeing late stage cell therapy CMOs (Ph2/3 trials)
  • Experience managing portfolios/multiple programs simultaneously, keeping detailed timelines and budgets for each program
  • Enjoys and thrives in cross-functional, matrixed team environments
  • Top notch organizational skills
  • Highly effective communicator across multiple levels of scientific expertise, both internally and externally, tweaking content to audience as needed
  • Proactive problem-solving approach