[Remote] Associate Director, Clinical Science

Note: The job is a remote job and is open to candidates in USA. Geron Corporation is focused on supporting the clinical development activities of one or more clinical trials. The Associate Director of Clinical Science will lead the preparation of clinical documents, conduct data reviews, and collaborate with stakeholders to ensure efficient execution of clinical trial programs.ResponsibilitiesLeads activities in preparation of protocols, amendments, and other clinical documents such as informed consents, clinical study reports, and investigator brochuresConducts data review and activities, including eligibility confirmation and routine review of safety and efficacy parametersWorks effectively with internal and external stakeholders to ensure efficient execution of the clinical trial programs, including study design, protocol writing, start-up, execution, analysis, and submission to regulatory authoritiesProvides protocol training at kick-off meetings, study team trainings, investigator meetings, and other internal/external meetings as applicableCollaborates with data management (DM) and cross-functional study team in electronic Case Report Form (eCRF) development and other DM activities, such as edit check development and database lock processesInteracts with clinical investigators during trial setup, conduct, and monitoringLeads deliverables and presentations for data monitoring and other review committeesCollaborates on the interpretation, reporting, and preparation of oral and written results with senior clinical personnelSkillsBachelor's degree in a scientific field or related area; advanced degree preferredMinimum of 7 years of experience in drug development Phase I-III within the pharmaceutical or biotechnology industryOncology experience required; hematology-oncology experience highly preferredProven track record of working effectively within a multi-disciplinary team environment of oncology drug development, particularly Phase I-IIIDemonstrated experience in clinical data review, protocol and clinical document development, and data monitoring activitiesKnowledge of Good Clinical Practices (GCP) and regulatory requirements for the conduct of trialsComfortable proactively solving issuesStrong strategic skills and agilityDeveloped understanding of clinical oncology and the drug development process, including regulatory, drug supply, preclinical development, and commercializationStrong and effective leadership skills of multi-disciplinary teams within an environment of oncology drug developmentAbility to work independently within a defined strategic contextComfortable taking initiatives and smart risksAbility to articulate effectively with strong verbal presentation skillsGood business judgement and excellent organizational skillsBenefitsMedicalDentalVisionLife insuranceFlexible spending accountsDisability insuranceSupplemental health insuranceA 401(k) retirement savings planAn employee stock purchase planA generous time off program that includes the eligibility to accrue 160 hours of vacation during each full year of employment64 hours of sick leave9 standard paid holiday days offPaid leave for certain life eventsCompany OverviewGeron is a biopharmaceutical company that is charting a new course with the goal to deliver innovative treatment options for people living with blood cancer. It was founded in 1990, and is headquartered in Foster City, California, USA, with a workforce of 201-500 employees. Its website is http://www.geron.com.