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Fractional CMO - Gene Therapy / Oncology

Berkeley, CA 94710

Posted: 05/05/2025 Employment Type: Contract To Hire Industry: Medical Affairs Job Number: 12134 Pay Rate: $500.00 - $800.00 Remote Friendly: Onsite

Job Description

Company Overview:
Our client is an innovative biotech startup focused on revolutionizing gene therapy delivery to unlock the full potential of immunotherapy for treating cold, solid tumors. The company is developing best-in-class, intravenous (IV)-administered oncotherapy products aimed at improving delivery, efficacy, and safety in the treatment of solid cancers. Utilizing their proprietary discovery platform, they are leading the charge to create transformative treatments that could change the landscape of cancer therapy.
Position Overview:
The Fractional Chief Medical Officer (CMO) will play a pivotal role in shaping the clinical strategy for the company’s oncology pipeline, from the design of early-phase clinical trials to the seamless integration of nonclinical and clinical development strategies. Working closely with the CEO and core team, the CMO will provide expert guidance on trial design, clinical indication selection, and patient stratification based on genetic, biomarker, and disease progression data. This is an exciting opportunity for a highly experienced medical leader to contribute to cutting-edge cancer therapies at a critical early stage of development.
Key Responsibilities:

  • Strategic Clinical Leadership:
    Work with the CEO and leadership team to define and align initial indications for the gene therapy assay, with a focus on oncology and specific patient subsets defined by genetics, biomarkers, and disease progression.

  • Clinical Trial Design:
    Lead the creation and refinement of a high-level skeletal Phase I clinical trial focused on oncology, including integration of the standard of care for disease indications, and strategies for collecting and analyzing efficacy data.

  • Nonclinical Integration:
    Act as a thought partner to ensure the smooth translation from nonclinical studies to clinical trials. Provide guidance on how nonclinical data can be integrated into clinical designs to streamline the transition and ensure the trials are robust and well-designed.

  • Cross-functional Collaboration:
    Collaborate with cross-functional teams, including R&D, regulatory, and clinical operations, to ensure that clinical and nonclinical aspects are aligned, and the clinical trial designs are optimized for success.

  • Fractional Consulting:
    Serve as a fractional consultant, balancing time between strategic consulting and tactical leadership, offering expert input on medical and scientific decisions while working in a flexible, part-time capacity.

  • Regulatory Guidance:
    Provide input on regulatory strategy, ensuring clinical trial designs and data collection align with regulatory requirements and expectations for gene therapy in oncology.

  • Patient Subset Identification:
    Guide the identification of patient subsets for clinical trials, considering key factors like genetic profiles, biomarkers, and disease progression.

  • Efficacy and Safety Strategy:
    Develop strategies to monitor and assess both the efficacy and safety of the company's gene therapy products throughout the clinical trial process, ensuring strong clinical data generation.

Job Requirements

Qualifications:
Educational Background: 
  • MD, PhD, or equivalent in a relevant scientific discipline (Oncology, Immunotherapy, Genetics, etc.

Experience: 
  • At least 10 years of experience in oncology drug development, including clinical trial design, biomarker-driven patient stratification, and patient safety.

  • Proven experience as a Chief Medical Officer (CMO), VP of Clinical Development, or similar leadership role in a biotech or pharmaceutical setting.

  • Extensive knowledge of Phase I oncology clinical trials and the integration of nonclinical data into clinical trial design.
  • Strong background in gene therapy, immunotherapy, and/or oncology drug development.

Skills & Attributes:

  • Strong leadership and communication skills, with the ability to collaborate effectively with C-suite executives, researchers, and external stakeholders.

  • Ability to provide strategic input on clinical trial design, with an understanding of regulatory and scientific requirements in oncology and gene therapy.

  • Proven track record of successfully leading or advising on early-phase clinical trials in oncology.

  • Comfortable working in a fractional consulting capacity, with flexibility to balance high-level strategy with tactical leadership.

Meet Your Recruiter

Jay Hite
Recruiter, Account Manager

As a Recruiter at Compass, Jay enjoys meeting job seekers and helping them to find new and exciting opportunities. He enjoys the process of getting to know candidates and learning all about their experience and what their future goals are. Jay feels the excitement of his candidates and is passionate about helping to find a fit both culturally and professionally. 

When Jay isn’t working, he enjoys bike rides, trying out new foods, tequila tasting and watching movies.  

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