Clinical Scientist, Oncology (Director)

Company Profile:

At Verastem Oncology, our purpose is to create a world where no cancer patient ever runs out of options. This commitment is central to who we are as a company and the culture we nurture. We are laser focused in our efforts to establish VS-6766 as the backbone therapy for RAS-mediated tumors. We look for people who share our perspective; when others see only a problem, we see an opportunity, when others give up, we step up. We partner with global leaders (and their teams!) in low grade serous ovarian cancer and non small cell lung cancer, and these relationships help us to serve the patients who need us most. We appreciate your candidacy for the Verastem Oncology team, and encourage you to learn more at www.verastem.com. We offer competitive compensation packages and comprehensive benefits. Join our team and contribute to our mission of improving patients' lives through cutting-edge biotechnology.

Clinical Scientist, Oncology (Director)

Responsibilities:

• Develop effective working relationship with key investigators in assigned programs to optimize scientific quality/innovation of clinical study design, execution, reporting and publication.
• Responsible for the clinical/scientific development/authorship and execution of designated clinical trials in close partnership with the other key members of the development team.
• Be responsible for analyzing and interpreting study data, in close collaboration with data sciences functions as well as medical and safety functions from an individual study perspective and translating study level clinical data across the clinical program of a study drug
• Maintain current knowledge of the external environment to ensure scientific innovations are considered and/or incorporated into clinical trial development strategy.
• Lead activities to obtain real time availability of quality clinical trial data, including safety, efficacy, pharmacokinetic and biomarker data, to provide consolidated information in close collaboration with data sciences functions.
• Review and summarize relevant literature on the clinical development programs.
• Develop and maintain strong, collaborative relationships with the broader Verastem Organization.
• In close partnership with Clinical Operations and other applicable functional areas, ensure that all studies are conducted with the highest level of ethical and safety standards and are in compliance with GXP and all regulatory policies.
• Support advisory boards, steering committee meetings, consultant meetings and investigator meetings, including preparation and delivery of presentations.
• Communicate/coordinate with investigators and review and query, as needed, clinical trial data, in close partnership with the medical, safety, clinical pharmacology and data sciences function, to ensure quality and integrity of study data and appropriate medical/safety oversight.
• Contribute and/or lead to the development/authorship of clinical sections of regulatory documents such as Investigators’ Brochures, briefing books, safety updates, IND/NDA submission documents, and responses to Health Authorities questions
• Key contributor to the clinical development plan and additional program level documents and presentations.
• Accountable for the clinical/scientific aspects clinical trial, includes investigator meeting presentations and monitoring of emerging clinical/safety data.
• Key member of the integrated clinical development team for designated clinical trials and programs.
• Support or lead investigators meetings and protocol training meetings, in close partnership with the medical monitor and safety lead
• Author/review abstracts, presentations, and manuscripts for external publications together w co-authors and relevant functional areas.
• Contribute to and/or lead development/authorship of key strategic and clinical documents including clinical development plans, protocol synopsis/ protocol, informed consent form, study training materials and clinical study reports.

Qualifications:

• Ph.D./RN/MS with at least 5-8 years experience as a Clinical Scientist with preference given to oncology clinical strategy, execution, and data and safety analysis
• Prior experience with multiple NDA submissions and global trials preferred
• Good interpersonal skills and the ability to work in a highly collaborative manner
• Proven track record of being a self starter, excellent communicator, and critical thinker is key to this role