Apply on Employer Site

Star Therapeutics · 2 months ago

Senior Clinical Scientist / AD, Clinical Science (Contractor)

South San Francisco, CA

Full-time, Contract

Hybrid

Senior Level, Lead/Staff

$90/hr - $130/hr

5+ years exp

Star Therapeutics is a Phase 3 clinical stage biotechnology company focused on developing innovative antibody therapies for serious diseases. They are seeking a Senior Clinical Scientist / Associate Director to support clinical science deliverables, including study design, data analysis, and regulatory filings, while also potentially serving as a Medical Monitor for clinical studies.

Health CareMedicalTherapeutics

Responsibilities

Develop and/or contribute to key documents to support the components of trial execution and regulatory submissions (e.g., IND Annual Reports, Investigator Brochures, Briefing Books, and Pediatric Plans)

Develop scientific rationale for methods, design, and implementation of clinical protocols, data collection systems, and final reports

Act as the scientific subject matter expert and primary contact for the assigned clinical study; take a proactive approach to identifying issues and mitigating risk

Conduct periodic review of protocol deviations in collaboration with the Clinical Operations Study Lead or designee

Perform clinical/medical data review, including safety monitoring and activities and procedures that ensure patient safety, data quality, and appropriate interpretation for assigned study/studies

Lead and participate in operational excellence projects and audit readiness activities, as appropriate

Initiate and provide scientific content and insight for development and review of: protocols, protocol amendments; ICFs; CRFs; statistical tables and listings including accurate AE (MedDRA) and concomitant medications (WHODrug) coding; audit reports; clinical study reports; inspection readiness activities, regulatory submissions; and other key study deliverables

Contribute to and review Clinical Study Report (CSR) writing (review final tables, listings, and figures; work with medical writer to review & revise CSR document; draft discussion and conclusions; and participate in comment resolution meetings)

Support the design, update, and implementation of Clinical Development Plans (CDPs) and work with functional leadership to ensure progress is in line with current plans and timelines

Collaborate with translational research on biomarker selection and data interpretation, design of non-clinical experiments, and analysis of subject samples to support clinical efficacy and safety evaluation

Stay up to date with advances in the rare blood disorders literature, including mechanism of action, diagnostic tests, standard of care treatments, drug development trends, and regulatory requirements

Assist with content development and attend and present at Investigator Meetings and other internal and external stakeholder meetings, as needed

Present study updates and topline results to Clinical Development leadership, as needed

Performs other related duties as assigned

Qualification

Clinical Science experienceRegulatory submissionsClinical research regulationsData analysisMicrosoft Office proficiencyDetail-orientedClear writing skillsPresentation skills

Required

Advanced science/health degree, such as PhD, PharmD, MSN

At the Sr Clinical Scientist level – the position requires at least 5 years of experience within Clinical Science, preferably in late-stage clinical development programs

At the AD, Clinical Scientist level, the position requires 6-8 years of experience, preferably in late-stage clinical development programs

Ability to navigate EDC and laboratory database systems to review data

Proficient in clinical research regulatory requirements (e.g., GCP and ICH)

Proficient with Microsoft Word, Excel, and PowerPoint

Ability to write clearly and concisely

Ability to present with clarity and compellingly

Detail-oriented

20% - 25% travel required