Director, Program Lead

Arcellx, Inc. (http://www.arcellx.com/) is a clinical-stage biotechnology company reimagining cell therapy by engineering innovative immunotherapies for patients with cancer and other incurable diseases. Arcellx believes that cell therapies are one of the forward pillars of medicine and our mission is to advance humanity by developing cell therapies that are safer, more effective, and more broadly accessible. Our offices are located in Gaithersburg, Maryland, and Redwood City, California.

Arcellx's lead product candidate, CART-ddBCMA, is being developed for the treatment of relapsed or refractory multiple myeloma (r/r MM) in an ongoing study. CART-ddBCMA has been granted Fast Track, Orphan Drug, and Regenerative Medicine Advanced Therapy designations by the U.S. Food and Drug Administration.

Arcellx is also advancing its dosable and controllable CAR-T therapy, ARC-SparX, through two programs: ACLX-001 for r/r MM and ACLX-002 in relapsed or refractory acute myeloid leukemia and high-risk myelodysplastic syndrome.

Arcellx is looking for an experienced program business leader with a demonstrated track record of crafting and delivering drug development and commercialization strategy that produces results through effective team leadership, collaboration, and influence across the organization. The Program Lead will manage the lead program timeline and will engage with cross-functional stakeholders to ensure alignment, timely decision making, and escalation of program challenges. 

In this role, you will be accountable for the Arcellx pipeline program strategy, including our lead CART-ddBCMA program in patients refractory to multiple myeloma. The Program Lead role reports to the Chief Business Officer and will partner with Arcellx’s senior management to lead a multidisciplinary team of functional experts to advance our development pipeline programs through pivotal clinical trial, secure global regulatory approval and market access, scale manufacturing capacity, and maximize commercial value.

The ideal candidate will have an exceptional ability to understand the science, clinical, CMC, competitive landscape, and commercial / business implications, as well as the complex, cross-functional considerations critical to development and commercialization of innovative therapies.

 Key Responsibilities: 

• Develop lead program strategy and vision that encompasses the overall Arcellx platform strategy and ensure execution of strategy through clinical, CMC, and commercial development.
• Responsible and accountable for delivering program strategy while managing the program timeline across cross-functional workstreams, ensuring alignment of key deliverables, anticipating and mitigating risks, and driving accountability across the organization.
• Partner with functional leads to support CMC development and commercialization activities and ensuring clinical supply for the early and late-stage portfolio.
• Identify, develop, articulate, and present strategic options to make the best trade-off decisions.
• Partner closely with Research, Development, Clinical, Commercial, CMC, and other G&A functions to ensure alignment on program strategy, priorities, timelines, resources, budget and deliverables, ensuring that strategy is reflected in the program operations.
• Escalate and resolve key issues with the senior management team.
• Develop reporting cadence to ensure visibility to the organization on timeline, progress-to-date, upcoming key milestones, and identified risks.

Qualifications: 

• 10+ years of clinical drug development and extensive commercialization experience in oncology and / or previous management consulting experience.
• Master’s degree or PhD preferred.
• Broad understanding of the evolving clinical and global commercial landscape in oncology and cell therapy.
• Outstanding strategic planning and analytical skills with the ability to synthesize findings and articulate implications from multiple sources of information to formulate strong recommendations and uncover market opportunities.
• Expertise in use of project management tools and oversight of project timeline management.
• Demonstrated experience leading at scale, motivating teams, and influencing senior leaders and key stakeholders.
• Ability to work in a fast-paced, changing environment with deadlines.
• Ability to take initiative, build productive relationships, work cross-functionally, and manage multiple projects.

Competencies:

• Has character and integrity. Committed to always doing what’s right.
• Self-motivated and able to work autonomously. Can produce top-quality work with little oversight.
• "No job is too small" mentality. Humble and willing to help others.
• Able to build strong relationships and collaborate effectively with colleagues.
• Gives direct, candid, and respectful feedback. Can receive feedback with curiosity and without getting defensive.
• Always looking to improve and challenge the status quo. Gritty and determined.

Salary Range: $230,000 - $260,000 per year.