Position Description

We are seeking an entrepreneurial Medical Immunologist to assume the role of Senior Medical Director for our innovative allogeneic regulatory T cell therapy programs. The ideal candidate thrives in a dynamic, fast-paced startup environment and is eager to embrace new challenges. This pivotal position, reporting directly to the Chief Medical Officer, involves contributing to design and overseeing clinical trials from phase I to later phase 2 and 3 leading to BLA. As a key member of our organization, you will have significant exposure to executive leadership. This role is based at our San Diego headquarters.

Key Responsibilities

• Spearhead and collaborate with cross-functional study teams, including clinical research scientists, clinical operations, regulatory affairs, and biostatistics, to ensure the successful execution of the trial.
• Develop and execute the clinical development and business strategy for product development in autoimmune disease indications
• Orchestrate the design, initiation, execution, analysis, and dissemination of clinical studies
• Actively participate in study team meetings, investigator meetings, and other relevant forums to discuss trial progress, challenges, and opportunities
• Cultivate relationships with external clinical researchers and KOLs
• Provide medical expertise and guidance throughout the trial, including patient screening, enrollment, and management
• Convene and facilitate advisory boards with industry experts and investigators
• Author clinical study protocols and recommend trial sites, investigators, data outputs, and publications
• Ensure compliance with regulatory requirements, Good Clinical Practice (GCP) guidelines, and study protocols
• Collaborate with Clinical Operations to optimize trial execution
• Provide support for regulatory activities, medical affairs, and payer engagements
• Represent the company at external scientific and medical forums
• Manage annual budgets and operating plans for clinical studies
• Undertake additional duties as required

The Team – Yes You Belong!

We are building a diverse, bold, agile, and collaborative organization where each team member works closely and communicates respectfully with each other. Tr1X leadership has high expectations for themselves and for you (and so should you!): we expect the company and all its employees to be deeply focused on bringing Tr1X's cellular therapies to patients at an accelerated pace. Key attributes include a “can do” attitude, a strong work ethic, a collaborative spirit, and excellent interpersonal and communication skills.

Qualifications:

• Medical degree with specialization in Neurology (preferred), Immunology, Rheumatology, Nephrology or Gastroenterology
• Minimum 5 years of pharmaceutical or biotech industry experience, demonstrating proficiency in all development phases
• Extensive knowledge and experience in clinical research within an industry setting
• Experience in cellular therapy development is highly advantageous
• Comprehensive understanding of related disciplines (biostatistics, regulatory affairs, pharmacology, toxicology, cell therapy manufacturing, clinical pharmacology, and pharmaceutical sciences)
• Proven ability to collaborate across departments (Clinical Operations, Translational Research, R&D, Regulatory Affairs, Finance, Manufacturing, Process and Analytical Development)
• Excellent communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams and external stakeholders
• Ability to thrive in a fast-paced and dynamic environment with a proactive and adaptable approach to challenges
• Self motivated, with the ability to motivate and inspire teams to achieve results
• Meticulous attention to detail with strong multitasking abilities, analytical mindset, and problem-solving abilities
• Demonstrated scientific output (publications, abstracts, etc.)
• Strong knowledge of Good Clinical Practices, FDA regulations and guidelines and applicable regulatory requirements.
• Ability to effectively evaluate outside expert advice.
• Ability to communicate and explain immunologic and/or cell therapy technical issues to clinical, regulatory, biomarker, biostatistics, data management and manufacturing colleagues who may have a non-medical background.
• Authorization to work in the United States

We offer:

• Anticipated Base Salary Range: $265,000 - $355,000
• In addition to your base pay, our total rewards program consists of a discretionary annual target bonus, stock options, and 401k match
• We also provide top-notch health insurance plans for employees (and their families)