Global Program Lead, Immune-Oncology and Immunology

ModeX Therapeutics•Weston, MA

About The Position

The Global Program Lead, Immune-Oncology and Immunology will lead integrated program strategy and coordinate execution for assigned immunology and/or immune-oncology program(s). This role reports to the Chief Medical Officer and serves as the accountable leader for assigned project(s), working in partnership with functional leaders across Research, Clinical Development, Clinical Operations, Regulatory, CMC, PK/PD, Safety, Medical, Project Management, and external collaborators. The Global Program Lead manages the assigned project, leads the project team, and is accountable for integrated project decisions, cross-functional alignment, program execution, and milestone delivery within approved strategy. This role is responsible for translating approved development strategy into a clear, integrated plan and leading the team to execute it. The Global Program Lead will lead the cross-functional project team, align work across disciplines, surface risks and tradeoffs, and drive progress toward agreed milestones. The Global Program Lead will not directly supervise functional leaders unless separately assigned. Functional leaders retain accountability for functional standards, technical quality, people management, resource planning, and cross-project consistency. The role requires strong clinical development experience and leadership, sound medical knowledge and judgment, disciplined execution, clear communication, collaborative leadership, and the ability to lead in a matrix environment.

Requirements

M.D. and/or Ph.D. training/certification in immunology, and/or immune-oncology (including hematology).
10 or more years in oncology and/or immunology clinical drug development, including leadership of clinical-stage programs.
6 to 10 or more years of experience in immunology, and/or hemato-oncology, including lymphoma, leukemia, or myeloma.
Experience in early-stage immunology and/or oncology drug development is required.
Deep and strong medical training/knowledge in auto-immune diseases are preferrable or required.
Experience in biologics development is 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.
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 relying on direct reporting authority.
Strong analytical and problem-solving skills.
Track record of delivering clinical development milestones.
Ability to work with internal leadership, external advisors, investigators, and regulatory authorities.

Nice To Haves

Deep and strong medical training/knowledge in auto-immune diseases are preferrable or required.
Experience in biologics development is preferred.

Responsibilities

Lead assigned program(s) through cross-functional project teams.
Serve as the accountable program leader for 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.
Build team cohesion, clarify ownership, and drive disciplined follow-through across functions.
Ensure program discussions focus on decisions, risks, actions, owners, and timelines.
Lead integrated development planning for assigned program(s), in partnership with the Chief Medical Officer and functional leaders.
Coordinate execution of approved clinical development plans.
Identify key development options, operational implications, timeline dependencies, resource needs, and decision points.
Prepare recommendations for review by the Chief Medical Officer and appropriate governance forums.
Support development 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 drive execution of approved plans.
Provide leadership and be accountable for the integrated design and execution of early-stage clinical development programs, in partnership with the respective functions.
Provide input on clinical study data, reports, protocols, development plans, case report forms, and informed consent documents.
Track progress against key milestones and escalate issues when execution risk, timing risk, cost impact, or strategy implications become material.
Lead project team meetings and coordinate input from all relevant functions.
Clarify decisions, owners, next steps, and escalation needs.
Direct project team members on project priorities, deliverables, and timing, while ensuring team members remain aligned with their functional leaders on standards, technical quality, and functional best practices.
Partner closely with Clinical Operations on feasibility, site and vendor execution, operational readiness, enrollment risk, and timeline management.
Partner closely with Project Management to maintain integrated plans, track milestones, document decisions, and identify risks.
Work with project team members and functional leaders to surface risks, resolve cross-functional issues, and maintain progress against agreed project priorities.
Proactively identify risks to strategy, timelines, budget, resources, quality, and milestone delivery, develop mitigation strategies to ensure timely achievement of clinical milestones.
Partner with Project Management and functional leaders to develop mitigation plans.
Escalate material risks through the appropriate governance forum.
Make tradeoffs visible when timelines, resources, or priorities conflict.
Contribute to clinical trial design, protocol development, case report forms, informed consent documents, and study execution planning.
Be accountable at the project level for clinical trial design, protocol development, study execution planning, and oversight, in partnership with Clinical Operations, Regulatory, Safety, Medical, PK, Translational Medicine, and other relevant functions.
Support compliance with applicable regulatory standards, ethical guidelines, and internal quality expectations.
Partner with Regulatory and the Chief Medical Officer to prepare for health authority interactions.
Support development of regulatory documents and submissions, including INDs, NDAs, BLAs, and related materials as applicable.
Participate in regulatory strategy discussions for assigned program(s).
Build and maintain relationships with key opinion leaders, academic institutions, investigators, and external advisors.
Use external input to inform program strategy, clinical development planning, and decision preparation.
Ensure external advice is integrated through the appropriate internal decision process.
Support product communication strategy for assigned program(s).
Contribute to scientific publications, presentations, congress materials, advisory board content, and educational materials.
Partner with internal stakeholders to ensure external communications are scientifically accurate, strategically aligned, and appropriately reviewed.