Summary
Join Tr1X, a biotechnology company focused on engineering cures for autoimmune and inflammatory diseases, as an entrepreneurial Medical Immunologist to assume the role of Senior Medical Director for our innovative allogeneic regulatory T cell therapy programs.
Requirements
- 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
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
Benefits
- 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) to include medical, dental, vision and basic life insurance
