Geron Corporation is a development-stage biotechnology company specializing in the discovery and development of novel oncology compounds, particularly late development to lead to registration. The company has one molecule in a phase III trial and an active development program. Geron is seeking a Clinical Scientist with drug development experience to join the Oncology program and assist in leading the telomerase inhibitor (imetelstat) program.
The Associate Director / Director will be expected to:
- Lead clinical development activities for one or more clinical trials
- Lead activities in preparation of protocols and amendments and other clinical documents such as the informed consents, clinical study reports
- Lead clinical data review activities, including patient eligibility confirmation and routine review of safety and efficacy parameters
- Provide protocol training at kick-off meetings, study team trainings, Investigators Meetings and other internal/external meetings as applicable
- Collaborate with study team in the review and development of Data Management activities including development of eCRFs, edit checks, data review tools and database lock processes.
- Collaborate with study team Clinical Operations activities for trial set-up and conduct
- Provide oversight for day to day aspects of clinical protocol(s)
- Interact with clinical investigators during trial set up, conduct and monitoring
- Provide protocol level scientific review of information to support the development and updates for regulatory documents (i.e. IND submissions, IND Annual Updates, DSUR, Investigator Brochures, and briefing books) and aid in the development of responses to regulatory authorities when questions arise for the protocol
- Collaborate on the interpretation, reporting and preparation of oral and written results with senior clinical personnel
- Work effectively with internal stakeholders (e.g. Physicians, Biometrics, Translational Research, Regulatory Affairs, Data Management, Clinical Operations, Safety) and external stakeholders (e.g. Investigators, FDA, NCI, CROs etc.) to ensure efficient execution of the clinical trial programs from study design to protocol writing to start up to execution to analysis and submission to regulatory authorities
The Associate Director / Director should have:
- Proven track record of working effectively within a multi-disciplinary team environment within an environment of oncology drug development, particularly phase I-III
- Experience and knowledge in Good Clinical Practices and regulatory requirements for the conduct of trials
- Comfortable proactively solving issues and working independently
- Strong strategic skills and strategic agility
- Good understanding of clinical oncology and the drug development process, including regulatory, drug supply, preclinical development and commercialization
- Good understanding of cancer cell biology and its application to clinical experimentation
- Ability to work independently within a defined strategic context, and take initiatives and smart risks.
- Ability to articulate effectively with strong verbal presentation skills.
- Good business judgement and excellent organizational skills.
Qualifications and experience
- Bachelor’s Degree or Masters in sciences, health, or related area (Advanced degree, PhD, preferred)
- Hematology experience highly preferred; oncology experience required
- Minimum of 5-7 years experience in drug development phase I-III within the pharma or biotech industry (2 years experience in hematology preferred)
Position can be home or office-based (Parsippany, NJ) with travel