Associate Director/ Director, CMC Program Management
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.
ABOUT ARCELLX: Arcellx (http://www.arcellx.com/) is a venture-backed, early-stage biotech company focused on the development of novel cell-based cancer therapies. The company is located in Gaithersburg, Maryland and has assembled a team of biotechnology professionals with expertise in biologics discovery, characterization, and development. Lead products will incorporate proprietary technologies that enhance tumor-specific killing by genetically engineered human immune cells.
The main responsibilities will include but are not limited to:
- Successfully identify, recruit, and hire candidates across technical and business functions at all levels.
- Creatively develops and effectively executes new and progressive recruiting strategies, stays current on hiring trends and practices.
- Ability to influence and develop relationships with internal and external stakeholders to influence the success of developed initiatives.
- Leverages sourcing expertise and biotech industry knowledge/understanding to recommend best practices for active and passive candidate sourcing.
- Ensures that active candidate pipelines are maintained for hard-to-fill and critical positions. Develops and maintains appropriate recruiting metrics for hiring, such as cost per hire, time to fill, quality of hire, etc.
- Maintains a comprehensive understanding of current state and federal employment law and recruiting best practices; appropriately interprets and applies employment law and company policy.
- Participates and drives Employer Branding such as: Social media strategies , career fairs, career web site and other initiatives.
- 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.
- 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
Without exception, applicants must submit both a cover letter and resume to be considered for these positions and must have experience in one of the fields listed above.