Senior Medical Director, Immunology
2 weeks ago
Tr1X, a biotechnology company, is seeking an experienced Medical Immunologist to assume the role of Senior Medical Director for our innovative allogeneic regulatory T cell therapy programs. The ideal candidate will have a strong background in clinical research and a proven track record of leading clinical trials from phase I to later phase 2 and 3.
Key Responsibilities- Collaborate with cross-functional study teams to ensure the successful execution of clinical trials.
- 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.
- Cultivate relationships with external clinical researchers and key opinion leaders.
- 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.
- 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.
- 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.
This is an in-person role based at our San Diego headquarters, with a minimum three-day week on-site presence. Travel up to 15% of the time may be required.
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