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.
Responsibilities
- Leads activities in preparation of protocols, amendments, and other clinical documents such as informed consents, clinical study reports, and investigator brochures
- Conducts data review and activities, including eligibility confirmation and routine review of safety and efficacy parameters
- Works 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 authorities
- Provides protocol training at kick-off meetings, study team trainings, investigator meetings, and other internal/external meetings as applicable
- Collaborates 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 processes
- Interacts with clinical investigators during trial setup, conduct, and monitoring
- Leads deliverables and presentations for data monitoring and other review committees
- Collaborates on the interpretation, reporting, and preparation of oral and written results with senior clinical personnel
Skills
- Bachelor's degree in a scientific field or related area; advanced degree preferred
- Minimum of 7 years of experience in drug development Phase I-III within the pharmaceutical or biotechnology industry
- Oncology experience required; hematology-oncology experience highly preferred
- Proven track record of working effectively within a multi-disciplinary team environment of oncology drug development, particularly Phase I-III
- Demonstrated experience in clinical data review, protocol and clinical document development, and data monitoring activities
- Knowledge of Good Clinical Practices (GCP) and regulatory requirements for the conduct of trials
- Comfortable proactively solving issues
- Strong strategic skills and agility
- Developed understanding of clinical oncology and the drug development process, including regulatory, drug supply, preclinical development, and commercialization
- Strong and effective leadership skills of multi-disciplinary teams within an environment of oncology drug development
- Ability to work independently within a defined strategic context
- Comfortable taking initiatives and smart risks
- Ability to articulate effectively with strong verbal presentation skills
- Good business judgement and excellent organizational skills
Benefits
- Medical
- Dental
- Vision
- Life insurance
- Flexible spending accounts
- Disability insurance
- Supplemental health insurance
- A 401(k) retirement savings plan
- An employee stock purchase plan
- A generous time off program that includes the eligibility to accrue 160 hours of vacation during each full year of employment
- 64 hours of sick leave
- 9 standard paid holiday days off
- Paid leave for certain life events
Company Overview
Geron 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.