Senior Clinical Scientist, Immunology

As TRex Bio advances its first wholly owned asset into Phase 1 clinical trials, the company is seeking an experienced and dynamic Sr. Clinical Scientist, Immunology to design and implement clinical trials for the development of medicines for immune mediated diseases. Reporting to the Chief Medical Officer, the Sr. Clinical Scientist will be a key member of the clinical and translational development team. Come join our team! 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. 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 novel immunomodulatory drugs to clinic. A passion for teamwork, a can-do attitude, integrity and transparency are key attributes for this position. 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. Key Competency Requirements: 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. Compensation: 170k-200k, plus Discretionary Bonus. TRexBio offers a very competitive benefits including medical, dental, vision, short/long term disability, life insurance as well as 401(k) match, bonus and paid time leave. 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.