Medical Director, Immuno-Oncology Clinical Development Lead

Cugene Inc.; Waltham (MA); On-site; USD 120,000 - 180,000; Full time

Job summary

An established industry player in biotechnology is seeking a Medical Director to spearhead clinical development for groundbreaking immunotherapies. This role offers the chance to shape clinical strategies from inception to execution, working collaboratively with diverse teams to drive innovative therapies into clinical trials. Ideal candidates will possess deep expertise in immuno-oncology and a proven track record in early-phase clinical trials. Join a dynamic team dedicated to making a significant impact in the fight against cancer and autoimmune diseases, where your contributions will be pivotal in advancing cutting-edge therapies.

Qualifications

• 5-6 years of clinical experience in early-phase immuno-oncology trials.
• Proven ability to lead cross-functional teams and manage clinical development.

Responsibilities

• Lead the clinical development strategy for immunotherapy trials.
• Oversee protocol design, patient enrollment, and regulatory engagement.

Skills

Immuno-oncology expertise

Clinical trial leadership

Data synthesis and analysis

Cross-functional collaboration

Regulatory document preparation

Education

PhD in relevant field

MD or equivalent

Job description

Medical Director, Immuno-Oncology Clinical Development Lead

Medical Director, Immuno-Oncology Clinical Development Lead

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Job Type: 1-Year Contract initially, with possibility of extension or transition to FTE

Compensation: Negotiable;competitive and commensurate with experience

ABOUT US

Cugene is a Boston-based clinical-stage biotechnology company dedicated to developing next-generation immunotherapies for cancer and autoimmune diseases. With deep expertise in biologics, we use advanced molecular modeling and precision engineering to create proprietary biotherapeutics featuring tissue- and cell-selective targeting antibodies in bispecific and multifunctional formats, along with novel masking technologies for targeted drug delivery.

We seek high-performing team members who are skilled, proactive, and solutions-oriented—individuals who take initiative, embrace challenges, and are motivated to make a meaningful impact in advancing new therapies. At Cugene, employees contribute directly to shaping R&D, translational and clinical strategies, working collaboratively to move innovative science from the lab into the clinic.

JOB DESCRIPTION

As Cugene expands its clinical portfolio, we are preparing to initiate clinical trials for our lead novel immunotherapy for solid tumors. We are seeking a Medical Director to lead the program’s clinical development strategy and execute a FIH study. You will have the opportunity to shape clinical strategy and execution from the ground up and serve as a key clinical voice across internal and external stakeholders.

This role reports directly to the Executive Vice President of R&D and works closely with other functional teams. You will be expected to serve as a strategic clinical, medical and operational leader, where you will help to define and oversee all clinical aspects of the program – including protocol design, tumor indication prioritization, dose selection and dose escalation, drug administration, patient eligibility/enrollment, medical monitoring, and regulatory engagement.

This role is ideally suited for someone with direct hands-on leadership experience in early-phase clinical trials within pharmaceutical or biotechnology companies. The ideal candidate will have deep clinical insights on immunotherapies and must be able to thrive in dynamic, early-stage biotech settings where resourcefulness, scientific rigor, and a proactive approach are critical to driving novel therapies forward.

KEY RESPONSIBILITIES

Clinical Development & Medical Oversight

• Synthesize data from non-clinical and translational studies and translate it into a cohesive clinical study plan that is aligned with the drug’s MoA and expected study milestones

• Design a dose-escalation and dose expansion or backfill Phase 1 trial, using decision-tree models to enable protocol adaptability

• Work closely with clinical research and operations teams to execute studies

• Serve as Medical Monitor, providing continuous safety oversight throughout the trial lifecycle, reviewing AEs and SAEs, assessing causality, and informing patient-level medical decisions as needed

• Lead and coordinate Safety Review Committee (SRC) meetings and synthesize expert inputs to guide decisions on study modifications as needed

• Author and/or review key regulatory documents, including the study synopsis, protocol, investigator brochure, ICF medical monitoring plan, safety narratives, CSRs, briefing books, and IND dossier documents

Cross-Functional Collaboration

• Drive cross-functional planning and decision-making, proactively managing risks against the clinical development plan and study milestones

• Represent Cugene in interactions with study sites, regulatory agencies, advisory board meetings, and safety review committee

• Present clinical program progress and strategic direction to internal or external stakeholders

QUALIFICATIONS AND EXPERIENCE

• PhD preferred but not required

• At least 5-6 years of clinical experience leading early-phase (Phase I–II) immuno-oncology trials in biotech or pharmaceutical settings

• Must have immuno-oncology expertise, with a strong preference for biologics-based immunotherapy

• Proven ability to synthesize translational and preclinical data into actionable, adaptive clinical development strategies and FIH protocols; writing samples will be requested

• Demonstrated leadership in cross-functional team collaboration to drive execution

• Strategic thinker with an entrepreneurial mindset and a clear understanding of how to transition FIH trials into later-stage clinical development

• Willingness and ability to travel

COMPENSATION

This is an initial 1-Year contract on-site, 40 hours per week. Depending on mutual interest and performance reviews, there is a possibility of extension or transition to FTE position.

Compensation is negotiable and will be competitive and commensurate with experience

Seniority level

• Seniority level

  Director

Employment type

• Employment type

  Full-time

Job function

• Job function

  Health Care Provider

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