Scientific Director, In-vivo CAR-T

Responsibilities

• Provide strategic scientific guidance for in Vivo CAR‑T programs in development from New Molecule entity through commercial licensure activities.
• Lead CMC and scientific strategy for In‑Vivo CAR‑T development, driving control strategy across programs.
• Develop and implement technical approaches for In‑Vivo CAR‑T CMC development, including process and formulation strategies.
• Lead end‑to‑end CMC strategy (process development, formulation, scale‑up, and tech transfer) with direct impact on program scientific objectives.
• Design technical DOEs to establish and validate the control strategy and ensure alignment with global regulatory expectations and industry best practices.
• Define and drive the scientific strategy, incorporating innovative technologies and state‑of‑the‑art approaches for In‑Vivo CAR‑T.
• Identify, analyze, and resolve high‑impact, complex cross‑departmental technical issues and manufacturing investigations; establish clear resolutions and decision points.
• Own and proactively shape the product control strategy, risk assessments, and critical quality attribute framework.
• Lead preparation, review, and approval of technical and regulatory documents, including regulatory filings, patents, and scientific publications.
• Influence and engage external stakeholders and health authorities to help shape the regulatory landscape and accelerate approval pathways.
• Collaborate closely with internal partners (Supply Chain, Regulatory, Quality, Discovery, external partners) to align development, manufacturing, and commercialization activities.
• Build organizational capability and intellectual capital through mentoring, training, knowledge sharing, and scouting nascent scientific opportunities.
• Influences across disciplines with senior leaders and external partners to drive and align strategic and operational scientific activities between business functions.

• Ph.D. in cell biology, immunology, biological science, or related discipline with at least 10-12 years of experience or a M.S. with 15 years of experience in an academic or industry setting with a focus on CAR‑T therapies.
• Proven track record in CMC development with demonstrated successes in IND and BLA approval.
• Proven track record in leading technical/scientific team(s) and direct and/or indirect people management experience.
• Excellent written and oral communication skills and ability to influence peers, superiors, and partners is required.
• Primary in-depth experience in Cell therapy development.
• Excellent interpersonal skills with the ability to adapt effectively to manage a growing portfolio.
• Ability to work collaboratively in a complex, matrix/functional environment.
• Demonstrated ability to be self‑motivated and make difficult decisions in a timely fashion.
• Strong problem‑solving and organizational skills are required.