Vice President, Clinical Operations at Tr1X

San Diego, California, United States

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Not SpecifiedCompensation

Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, Pharmaceuticals, HealthcareIndustries

Requirements

Senior executive leadership experience in clinical operations within biotechnology or pharmaceutical industry
Expertise in establishing and advancing clinical operations strategy, governance frameworks, performance metrics, and operating standards
Proven ability to oversee design and execution of clinical trials, including alignment with corporate goals, timelines, budgets, regulatory standards, patient safety, and quality requirements
Experience evaluating and optimizing organizational structure, systems, and leadership capacity for scalability, efficiency, and compliance
Strong skills in selecting, negotiating, and managing CROs and key external vendor partnerships
Demonstrated cross-functional collaboration with teams such as translational sciences, clinical development, regulatory affairs, manufacturing, project management, and quality
Capability to build, lead, and mentor high-performing clinical operations teams, fostering culture of excellence and accountability
Proficiency in developing and overseeing clinical operations budgets, including financial forecasting, expenditure tracking, and cost-effective resource allocation
Knowledge of developing clinical operations infrastructure, including SOPs, study processes, databases, and tracking systems
Experience as executive sponsor for clinical operations initiatives, integrating with corporate strategy, portfolio planning, and investor communications

Responsibilities

Define and lead the clinical operations strategy in partnership with the CMO and Company leadership
Oversee the design and execution of clinical trials in alignment with corporate goals, timelines, budgets, regulatory standards, and patient safety and quality requirements
Evaluate organizational capabilities and implement structural or process improvements to enhance scalability and operational efficiency
Select, negotiate, and manage CROs and other key external partners, ensuring quality, fiscal discipline, and delivery excellence
Allocate appropriate resources to support clinical program needs for both internal and outsourced activities
Lead and collaborate with cross-functional colleagues including translational sciences, clinical development, regulatory affairs, manufacturing, project management, quality and others to ensure effective program execution and adherence to regulatory compliance
Develop and maintain Clinical Operations infrastructure, including SOPs, study processes, databases, and tracking systems
Build and lead a high-performing Clinical Operations team; set strategic priorities, develop senior leaders, and foster a culture of excellence and accountability
Develop and oversee the Clinical Operations budget including clinical study budgets, expenditure tracking, cost-effective resource allocation, financial forecasting, and adherence to fiscal responsibility
Ensure all clinical trials are conducted with scientific rigor, regulatory compliance, and operational excellence

Skills

Clinical Operations

Clinical Trials

Regulatory Compliance

Vendor Management

Budgetary Governance

Strategic Planning

Cross-Functional Collaboration

Governance Frameworks

Performance Metrics

Cell Therapy

Biotechnology

Tr1X

Develops cellular immunotherapies for autoimmune diseases

About Tr1X

Tr1X focuses on developing cellular immunotherapies aimed at treating autoimmune and inflammatory diseases. The company uses a proprietary platform to create cell therapy products that help to rebalance the immune system and restore its natural balance, which is essential for long-term health. Unlike many other companies in the biopharmaceutical sector, Tr1X specializes in first-in-class therapies that target the underlying causes of immune system disorders rather than just alleviating symptoms. The goal of Tr1X is to provide advanced therapeutic solutions that lead to lasting tolerance in patients, improving their quality of life.

San Diego, CaliforniaHeadquarters

2018Year Founded

$73MTotal Funding

SERIES_ACompany Stage

Biotechnology, HealthcareIndustries

11-50Employees

Benefits

Health Insurance

Dental Insurance

Vision Insurance

Life Insurance

Disability Insurance

Health Savings Account/Flexible Spending Account

Unlimited Paid Time Off

401(k) Company Match

Flexible Work Hours

Stock Options

Performance Bonus

Risks

Emerging competition in allogeneic Treg therapy could impact Tr1X's market share.

High manufacturing costs may pose financial risks for Tr1X.

Regulatory hurdles could delay Tr1X's product development and market entry.

Differentiation

Tr1X uses a proprietary platform for novel cellular immunotherapies.

The company focuses on allogeneic regulatory T-cell therapies for autoimmune diseases.

Tr1X's TRX103 is the first allogeneic engineered Tr1 regulatory T cell product.

Upsides

FDA clearance for TRX103 IND boosts Tr1X's credibility and market potential.

$75M Series A funding supports rapid development of Tr1X's therapies.

Growing autoimmune therapeutics market offers significant opportunities for Tr1X's products.

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