Senior Medical Director, Immunology Job at Tr1X, San Diego, CA

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  • Tr1X
  • San Diego, CA

Job Description

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: $250,000 - $350,000
  • 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) to include medical, dental, vision and basic life insurance
  • The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience and education

Location:

This is an in-person role based at our San Diego headquarters, with a minimum three day a week on site presence. Travel up to 15% of the time may be required.

 

Job Tags

3 days per week,

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