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TRexBio · 1 day ago

Senior Clinical Scientist, Immunology

South San Francisco, CA

Full-time

Hybrid

Senior Level, Lead/Staff

$170K/yr - $200K/yr

10+ years exp

TRexBio is a clinical stage biotechnology company focused on developing therapeutics for inflammatory diseases. The Senior Clinical Scientist will support clinical development planning and contribute to the design and execution of early phase clinical trials, collaborating with cross-functional teams to ensure successful trial outcomes.

BioinformaticsBiopharmaBiotechnology

Responsibilities

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

Qualification

Clinical research experienceImmunology expertiseGCP/ICH knowledgeClinical trial designMedical writing skillsData interpretationPharmacology knowledgeMicrosoft Office proficiencyCommunication skillsTeamworkProblem-solving skillsDetail-orientedInitiative

Required

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)

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%)

Preferred

Expertise in Immunology and biologics medicines development for immune mediated diseases preferred

Benefits

Discretionary Bonus

Company

TRexBio

TRexBio is a clinical-stage biotechnology company discovering and developing immunoregulatory medicines based on tissue Treg biology by leveraging cutting-edge computational biology tools, a focus on human tissue, and deep immunobiology expertise.

Founded in 2018

South San Francisco, California, USA

11-50 employees