Arcellx (https://arcellx.com/) is a venture-backed, early-stage biotech company focused on the development of novel cell-based cancer therapies. The company 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. Arcellx’s vision is to bring ARC-sparX platform cell therapies to millions of patients who can self-administer prescribed sparX proteins under the care of academic and community practices.
We are seeking an experienced biopharmaceutical General Counsel to join and build our legal team. The ideal candidate has a strong background in the biotechnology industry supporting and providing advice on a broad range of strategic matters for the Company’s regulatory, compliance, commercial, and other corporate legal issues. Most importantly, the ideal candidate must be able to bring creative solutions to legal and regulatory challenges by working closely as a strategic advisor and business partner to the CEO, senior team, and Board of Directors to ensure Arcellx’s business practices, policies, and programs comply with all legal requirements. This role will be seated in the company’s Northern California office and will report to the CEO.
- Provide high quality, timely and practical legal advice, and guidance, identify, and help resolve critical legal and business issues arising from regulatory, pre-clinical, clinical, technical operations, and research and development activities.
- Establish and maintain working relationships with all levels of management and become a trusted and advisor on legal and compliance matters. Partner with the leadership team to formulate and drive overall business and growth strategy of the company while providing practical legal advice relating to applicable laws and regulations, as well as contractual obligations.
- Serve as Corporate Secretary by supporting the Board and its committees in cooperation with other members of the executive team while providing guidance on all corporate governance-related matters.
- Define and drive the IP strategy for Arcellx ‘s by supporting the management and growth of the company’s IP portfolio.
- Provide advice and guidance for the accomplishment of the overall business objectives in compliance with applicable laws and regulations and avoidance of unacceptable risks. Keep abreast of practices, standards, and trends affecting the company and biopharmaceutical industry.
- Provide regulatory environment, support the company’s engagement with the FDA and provides updates on key activities at FDA and other agencies . Work closely with the Regulatory team to develop and draft responses to inquiries and investigations with external regulatory bodies as needed.
- Work closely with the Sr. Director of Contracts to draft and prepare contracts and agreements and other legal documents.
- Provide counsel to the senior team ; including but not limited to HR leadership on all HR and employment matters, Clinical, Regulatory, Program Management, and Research and Development.
- Manage and provide strategic guidance for disputes and litigation matters and effectively manage outside counsel and other external advisors.
- Ability to apply legal expertise, drafting, and negotiation skills to counsel and support Technical Operations functions to effectively manage risks on contractual matters, including drafting, review, and negotiation of legal agreements related to Technical Operations (e.g., logistics, supply, manufacturing and supply, development manufacturing and services, CMOs, outsourcing, quality technical agreements, etc.).
- Serve as the principal legal advisor on all divestitures, alliances, mergers and acquisitions, and other complex commercial transactions.
- JD required and 15+ years’ experience with regulatory requirements in the biotechnology or pharmaceutical industry required.
- Experience in a Start-Up and fast-growing biotechnology organization preferred.
- Significant experience advising on, drafting and negotiating agreements and excellent knowledge and experience with laws and regulations governing the biotechnology industry., including FDA, False Claims Act, Anti-Kickback Statute, OIG guidance, the PhRMA Code, HIPAA, GDPR and other privacy laws, and product liability laws.
- Great leadership qualities including experience managing cross-functional legal teams, as well as sound business and legal judgment, and strategic and analytical thinking.
- Experience working with all levels of management and key business stakeholders with a demonstrated ability to influence outcomes and effectively communicate legal risks to executive leadership and senior management.
- Excellent organizational and planning skills, with the ability to handle multiple projects simultaneously.
- Grit and Passion – An energy, persistence and drive to accomplish great things and build the company. A visible, “in the arena” attitude with optimism to push through challenging times for the benefit of those Arcellx serves.
- Ownership Mindset – Acts with an intense sense of ownership over results and the company’s success. “Roll-up-your-sleeves” approach.
- Team Orientation – Collaborative style. Fosters team-first mentality and shares wins and successes. Creates an open and transparent environment in which individuals can team together to drive optimal outcomes.
- Presence and Gravitas – A natural, confident communicator who is able to present ideas discerningly, articulately and openly with the ability to effectively influence and marshal buy-in from people at all levels; a leader with a strong presentation style.
- Integrity – Unquestionable integrity. Known as an honest, trustworthy, ethical and straightforward individual.
Submit cover letter and resume to: firstname.lastname@example.org
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.