Senior Director, Regulatory Affairs

Location: South San Francisco, CA – Hybrid, with the ability to be in office 2-3 days per week

Position Summary:

The Senior Director, Regulatory Affairs will serve as the regulatory leader for TRexBio’s pipeline.

The Senior Director will work closely with the clinical and pre-clinical teams to formulate regulatory strategies, lead execution of regulatory deliverables, and provide key insights that enable the successful execution of pre-clinical and clinical trial programs.

This role also involves engaging with external stakeholders such as the FDA, EMA, and other regulatory bodies, and managing regulatory service providers. The candidate must not only be adept at formulating and driving strategy, but also be tactically oriented, an exceptional leader with strong management skills who plays a hands-on role.

The ideal candidate will have a proven ability to partner effectively with multiple functional leaders, including Clinical Operations, Clinical Science, Research, Translational Science, Manufacturing, Quality, and Product Strategy. Strong interpersonal skills are essential, as this individual will serve as a trusted voice within the company. The candidate must demonstrate outstanding leadership and management skills, rigorous scientific intellect, and an understanding of the business aspects of drug development.

At a personal level, the company is seeking a highly motivated individual who thrives on being challenged in a startup and highly collaborative environment to contribute to leading science in the interest of patient care.

This position will report to the Chief Medical Officer, and will be based in the TRexBio office in South San Francisco, CA.

Key Responsibilities include but are not limited to:

• Serve as a key member of cross functional clinical and pre-clinical teams to develop and implement the US and global regulatory strategy across products
• Lead Regulatory deliverables including INDs, CTAs, and other submissions
• Oversee development of regulatory policies and procedures and SOPs
• Engage with regulatory authorities as appropriate for product development
• Monitor the competitive environment to sustain expertise in therapeutic area treatment management and new therapies, competitive products and features

Required Qualifications:

• Advanced degree (Master's or PhD) in Life Science with experience working as a regulatory project lead for INDs, CTAs, and BLAs
• Minimum 10 years of documented professional experience in Regulatory Affairs, including in leadership positions within the biopharmaceutical industry with focus on biologics
• Strong understanding of clinical development and how to present clinical data to FDA as well a proven track record in developing regulatory affairs strategies
• Extensive regulatory experience including IND/CTA, NDA/BLA/MAA, lifecycle management, labelling, and developing regulatory strategies
• Proven ability to collaborate effectively with multiple functional leaders, including Research, Development, Clinical, product Strategy, Manufacturing, and Quality across locations and cultures
• Ability to travel domestically and internationally
• Broad experience in Regulatory Affairs, working directly with FDA and international agencies
• Experience with immunology and development of medicines for immune mediated diseases, biologics, CMC, Toxicology, Orphan Drugs development, breakthrough and fast track regulatory processes
• Strong leadership experience, including mentoring staff and managing regulatory teams across locations
• Excellent writing, communication, and presentation skills

Compensation: $220,000 – $290,000, plus Discretionary Bonus.

TRexBio is a clinical stage biotechnology company leveraging cutting edge computational biology tools, a focus on human tissue, and expertise in immunobiology to develop revolutionary therapeutics for inflammatory diseases. Our powerful ‘deep biology’ discovery engine maps human tissue Treg behavior to disease processes, allowing us to identify and characterize novel targets for therapeutic intervention. Leveraging this platform, we are building a broad portfolio of novel therapies that modulate the immune system to restore human tissue immune homeostasis.

Our Culture:

At TRexBio, you will have the opportunity to work with amazingly smart humans who strive to make the world a better place. In addition to our team-centric culture, we believe that your individual creativity will help us to be our best. Our staff happy hours, organized by our Culture Club, bring us all together in creative and social activities. Our colleagues admire and respect one another. We celebrate our wins, update company news and acknowledge each other’s achievement weekly and monthly at all company meetings that celebrate our work and our people.

TRexBio is proud to be an AA/EEO employer and all qualified candidates will receive consideration without regard to characteristics protected by applicable local, state, or federal law, such as race, color, sex, age, religion, national origin, physical or mental disability, pregnancy, marital status, veteran or military status, genetic information, or sexual orientation.