Gritstone Oncology (Nasdaq: GRTS), a clinical-stage biotechnology company, is developing the next generation of cancer immunotherapies to fight multiple cancer types. Gritstone develops its products by leveraging two key pillars—first, a proprietary machine learning-based platform, Gritstone EDGE™, which is designed to predict, from a routine tumor biopsy, the tumor-specific neoantigens (TSNA) that are presented on a patient’s tumor cells; and second, the ability to develop and manufacture potent immunotherapies utilizing patients’ TSNA to potentially drive the patient’s immune system to specifically attack and destroy tumors. The company’s lead product candidate, GRANITE, is a personalized neoantigen-based immunotherapy in Phase 1 clinical testing. Gritstone’s second product candidate, SLATE, is a shared neoantigen, “off-the-shelf” immunotherapy which is also being evaluated in a Phase 1 clinical study. Novel tumor-specific antigens can also provide targets for bispecific antibody (BiSAb) therapeutics for solid tumors, and Gritstone’s BiSAb program is currently in lead optimization.
The primary role of the Associate Director/Director, Clinical Science is to provide scientific expertise to clinical development programs including strategic input and development support for clinical plans and individual study protocols. This role will work on cross-functional study teams for the design and execution of clinical studies, as well as analysis, interpretation, and communication of clinical study data. Essential duties and responsibilities include but are not limited to the following:
- Provide clinical research input for early clinical drug candidates and support Target Product Profile development
- Contribute to the clinical development strategy, clinical development plans, and prepare clinical protocols for compounds assigned to Company
- Prepare clinical development plans and protocols and the conduct of clinical research in accordance with Good Clinical Practices (GCP) and the standards of the International Conference on Harmonization (ICH)
- Close and productive communication with clinical sites to ensure patient eligibility, treatment, and appropriate reporting of clinical data
- Assist in the composition and review of clinical study reports, Investigational Drug Brochures, manuscripts, abstracts, General Investigational Plans, and other relevant documents
- Identify risks and recommend potential mitigation strategies that can impact the successful execution of a clinical study
- Analytical support of clinical trial data (safety and, efficacy, and biomarkers), including gathering, analyzing, reviewing, interpreting, and providing preliminary assessments and recommendations
- Composing internal and external presentations for scientific meetings (eg, investigator meetings, advisory boards, data presentations)
- Support and mentor Clinical Science/Medical staff on all projects assigned to company
- Provide review of clinical development plans and strategic initiative (e.g. task forces, protocol review committees)
These efforts will facilitate the efficient development and execution of clinical studies to support the development of groundbreaking, innovative treatment options for patients with cancer.
- Advanced degree in a scientific discipline preferred; ideally PhD, PharmD, MD, or equivalent. Master’s degree may be considered if candidate has substantial industry experience.
- 5+ years of relevant industry experience such as working for biotechnology or pharmaceutical company in clinical development or clinical research group with knowledge of drug development process, including conducting Phase 1 to 3 clinical studies and submission of Investigational New Drug Applications.
- Ability to work effectively in a fluid, fast-paced, team-based environment
- Self-motivated, self-disciplined and able to function independently as well as part of a team
- Contribute to the development and use of novel strategies to improve the efficiency of clinical studies
- Highly organized with attention to detail, clarity, accuracy, and conciseness.
- Strategic agility, strong critical and logical thinking with ability to analyze problems
- Strong presentation and written/verbal communication skills
- Excellent computer proficiency (MS Word, Excel, PowerPoint)