Senior Clinical Scientist, Immunology

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

Position Summary:

We are seeking a talented and highly motivated Senior Clinical Scientist to join our Clinical Development team. This position offers an opportunity to work as part of a small, dynamic team to bring immunomodulatory drugs to clinic.

A passion for teamwork, a can-do attitude, integrity, and transparency are key attributes for this position. Come join our team!

Key Responsibilities include but are not limited to:

• Support clinical development planning via assessment of unmet need, scientific data, regulatory landscape, and expertise in innovative trial design, methodology, and outcome measures
• Contribute to design of early phase (Ph1-2) clinical trials, together with cross functional experts
• Serve as a key author for clinical trial protocols, informed consent forms, relevant parts of investigators brochure, clinical documents for regulatory submissions including IND and CTAs, and other clinical trial documents
• Coordinate cross functional reviews of clinical documents in collaboration with clinical operations leader
• Review regulatory documents in collaboration with regulatory leader
• Create presentations for clinical trial sites and advisory board meetings
• Monitor clinical trial data during study conduct
• Provide input to clinical trial data interpretation
• In coordination with clinical operations leader, liaise with clinical trial site staff and clinical research organization
• Contribute to authoring of clinical study reports
• Collaborate with all study team members including Clinical, Medical, Clinical Operations, Drug Safety, Regulatory Affairs, Clinical Pharmacology, Toxicology and CROs

Required Qualifications:

• 10 years of experience in clinical science, clinical research, or equivalent in the biopharmaceutical industry
• Advance Degree in Clinical or Life Sciences (Pharm D, PhD, MD)
• Expertise in Immunology and biologics medicines development for immune mediated diseases preferred
• Proficient knowledge of GCP/ICH, drug development process, study design, statistics, pharmacology, clinical operations, early phase clinical research
• Proficient knowledge and skills to support data review, trend identification, data interpretation
• Excellent verbal, written, communication and interpersonal skills
• Must be able to effectively communicate and collaborate
• Ability to assimilate technical information quickly
• Routinely takes initiative
• Detail-oriented
• Strong sense of teamwork; ability to lead team activities
• Proficient in medical terminology and medical writing skills
• Knowledge of or proven ability to gain knowledge of relevant disease area(s), KOLs, indication(s), compound(s) under study (including MOA, PK/PD, biomarker & safety profile)
• Proficient critical thinking, problem-solving, decision-making skills
• Understanding of functional areas and cross-functional relationships
• Commitment to Quality
• Willing and able to adjust to multiple demands and shifting priorities as well as an ability to meet day-to-day challenges with confidence and professionalism
• Ability to develop short to mid-range plans that are realistic and effective in meeting goals
• Proficient in Microsoft Word, Excel, PowerPoint, and clinical trial data reporting tools
• Embraces and supports a start-up, small biotech work culture including innovation, resourcefulness, agility, and teamwork
• Domestic and International travel may be required (up to 25%)

Compensation: $170,000 - $200,000, 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.