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Manager Regulatory Operations-Trial Master File Management
Arcellx Inc
Redwood City, CA
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Arcellx Inc
Redwood City, CA
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Arcellx Inc
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Arcellx Inc
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Arcellx Inc

Director, Program Lead

Redwood City, CA, United States

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Job details

Experience: 10+ years of clinical drug development and extensive commercialization experience in oncology and / or previous management consulting experience
Posting language: English
Posted: Jun 9, 2022

Original job description

•

Arcellx (http://www.arcellx.com/) is a clinical-stage biotech company headquartered in Gaithersburg, MD and Redwood City, CA. Arcellx is focused on the development of novel cell-based cancer therapies. A team of biotechnology professionals with expertise in biologics, discovery and tumor immunology incorporate proprietary technologies into genetically engineered human immune cells therapies. Arcellx’s mission is to advance humanity by engineering cell therapies that are safer, more effective, and more broadly accessible.

• •

Arcellx is looking for an experienced program business leader with a demonstrated track record of developing and delivering drug development and commercialization strategy that can deliver 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 VP of Strategy and will partner with Arcellx’s senior management team 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 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 deliverable, ensuring that strategy is reflected in the program operations
Escalate and resolve key issues with 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 and build, productive relationships and work cross-functionally and manage multiple projects

Competencies:

Commitment to ethical scientific investigations and rigorous experimental methods.
Ability and desire to multitask and function in a fast-paced entrepreneurial environment.
Sense of urgency in performance of duties.
Interpersonal skills that promote a collaborative and productive lab environment.
Effective and efficient written and oral communication skills.

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More about this job

Skills

Biotechnology
Team leadership
Decision making
Research
Reporting
Strategic planning
Analytical skills
Project management
Multitask
Interpersonal skills
Communication skills

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