Associate Director, Clinical Science

Geron Corporation

1d•Hybrid

About The Position

The Associate Director of Clinical Science is responsible for supporting the clinical development activities of one or more clinical trials. This position is remote with a periodic presence for in-person meetings in the Parsippany, NJ headquarter office. This Associate Director will report to the Vice President, Clinical Science and Operations.

Requirements

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
Bachelor’s degree in a scientific field or related area
Minimum of 7 years of experience in drug development Phase I-III within the pharmaceutical or biotechnology industry
Oncology experience required
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

Nice To Haves

advanced degree preferred
hematology-oncology experience highly preferred

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