Global Program Lead, Immune-Oncology and Immunology

About the role

The Global Program Lead serves as the accountable leader for assigned immunology and/or immune-oncology programs, partnering with functional leaders across Research, Clinical Development, Clinical Operations, Regulatory, CMC, PK/PD, Safety, Medical, Project Management, and external collaborators. This role leads integrated program strategy, execution coordination, and milestone delivery, translating approved development strategy into clear, actionable plans. The Global Program Lead does not directly supervise functional leaders but drives cross-functional alignment and disciplined follow-through in a matrix environment.

Responsibilities

• Lead assigned program(s) through cross-functional project teams, ensuring integrated strategy, execution coordination, decision preparation, and milestone delivery.
• Coordinate across Research, Clinical Development, Clinical Operations, Regulatory, CMC, PK/PD, Safety, Medical, Project Management, and external partners to build team cohesion and drive disciplined execution.
• Lead integrated development planning in partnership with the Chief Medical Officer and functional leaders, identifying key development options, operational implications, timeline dependencies, and resource needs.
• Prepare recommendations for review by governance forums and support strategy discussions with internal leadership, external investigators, advisors, and regulatory authorities.
• Partner with Clinical Development, Research, Clinical Operations, Regulatory, Safety, Medical, and Project Management to execute approved clinical development plans.
• Provide input on clinical study data, protocols, development plans, case report forms, and informed consent documents.
• Track progress against milestones and escalate issues related to execution risk, timing, cost, or strategy.
• Lead project team meetings, clarify decisions, owners, next steps, and escalation needs, ensuring alignment with functional standards and best practices.
• Partner with Clinical Operations on feasibility, site execution, operational readiness, enrollment risk, and timeline management.
• Maintain integrated plans, track milestones, document decisions, and identify risks in collaboration with Project Management.
• Proactively identify risks to strategy, timelines, budget, resources, quality, and milestone delivery, and develop mitigation strategies.
• Escalate material risks through appropriate governance forums and make tradeoffs visible when conflicts arise.
• Contribute to clinical trial design, protocol development, case report forms, informed consent documents, and study execution planning.
• Support compliance with regulatory standards, ethical guidelines, and internal quality expectations.
• Partner with Regulatory and the Chief Medical Officer to prepare for health authority interactions and support regulatory document development (e.g., INDs, NDAs, BLAs).
• Build and maintain relationships with key opinion leaders, academic institutions, investigators, and external advisors to inform program strategy.
• Support product communication strategy, scientific publications, presentations, congress materials, and educational content, ensuring accuracy and strategic alignment.

Qualifications

• M.D. and/or Ph.D. in immunology, immune-oncology, or hematology highly preferred; candidates without an M.D. or Ph.D. may be considered based on relevant experience.
• 10+ years of drug development experience in biotechnology or pharmaceuticals.
• 6–10+ years of experience in immunology and/or hemato-oncology (e.g., lymphoma, leukemia, myeloma), with a focus on early-stage drug development.
• Deep medical knowledge in auto-immune diseases preferred or required.
• Experience in biologics development preferred.
• Strong clinical development judgment and experience shaping clinical strategy.
• Experience with clinical trial design and execution.
• Knowledge of regulatory requirements and experience interacting with regulatory agencies.
• Proven ability to lead cross-functional teams in a matrix environment.
• Strong interpersonal, communication, and collaboration skills.
• Ability to mentor team members and build team effectiveness without direct reporting authority.
• Strong analytical and problem-solving skills.
• Track record of delivering clinical development milestones.
• Experience working with internal leadership, external advisors, investigators, and regulatory authorities.

Success Profile

The successful Global Program Lead will bring leadership, clarity, discipline, and momentum to assigned programs. They will shape clinical development strategies, leverage deep medical expertise in auto-immune diseases and/or immune-oncology, and lead through influence rather than hierarchy. They will translate scientific strategy into executable plans, make timely decisions, and escalate when necessary. By respecting functional ownership while holding teams accountable, they will build trust and drive milestone delivery, helping ModeX scale from founder-led execution to stronger program leadership and coordination.