Tr1X (“Trix”) is a biotechnology company focused on engineering cures for autoimmune and inflammatory diseases. The company develops cellular therapies with the potential to cure disease by inducing immune tolerance and restoring homeostasis.
Tr1X has a state-of-the-art technology platform that allows for the scalable generation of engineered living drugs to help patients suffering from debilitating diseases with high unmet medical need. More information can be found at www.tr1x.bio
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.
At Tr1X we believe that a diverse, open, and inclusive environment and culture is key to our success. Tr1X will not be influenced in recruitment, hiring, promotion or any other employment practices by race, color, citizenship status, national origin, ancestry, sex, sexual orientation, gender identity/expression, age, religion, physical or mental disability, medical or genetic condition, marital status, veteran status, or any other characteristics protected under applicable federal, state and local laws. Tr1X will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable laws.
Note to External Recruiters: Submission of unsolicited resumes prior to an agreement set in place will not create any implied obligation.
#J-18808-Ljbffr
