Using CRISPR for next gen cancer precision medicine
Tumor genomic characterization has transformed cancer research and enabled personalized cancer treatment for some, but not all patients. At Function Oncology, we have created a tech and data platform that uses CRISPR to directly access functional biological data to guide next generation cancer precision medicine. Our goal is to overcome the limitations of sequence-based approaches to dramatically expand the number of patients who benefit from precision oncology. We believe in owning our work and moving with speed, with the ultimate goal of winning for the patients that our technology will serve.
The Senior Manager, Clinical Development Operations will support the successful design and day-to-day execution of pre-clinical and clinical studies from concept through publication. Key accountabilities include the successful conduct of studies consistent with applicable regulations, guidelines, and procedures and management of clinical project timelines, budgets, deliverables, and overall communications.
Duties and Responsibilities:
Essential duties and responsibilities include the following. Other duties may be assigned.
· Manage key deliverables for all aspects of assigned clinical studies, including investigator selection, study startup and site initiation, preparation of study documentation, including protocols, consent documents, laboratory manuals, biospecimen tracking, clinical data oversight, and closeout activities.
· Participate in project scoping, preparation of vendor requirements, and selection of study vendors; effectively manage interactions with vendor study teams.
· Conduct study feasibility assessments and lead selection of sites for study conduct.
· Independently manage CROs and other vendors, including contracts, budgets, and invoicing.
· Provide regular updates on study progress to stakeholders; proactively identify and resolve issues that arise during study conduct; manage escalation of study-related issues.
· Proactively identify risks and/or barriers to timely and successful study execution; propose and execute on mitigation strategies.
· Collaborate with data management on case report form (CRF) design, clinical trial data collection, and assist with data queries and audits to ensure data integrity.
· Ensure proper site training and management, provide ongoing oversight of clinical site compliance with study plans, study protocol, SOPs, ICH/GCP guidelines, and compliance with applicable US and/or international regulations.
· Occasional travel for company, vendor, or clinical partner meetings will be required.
· Perform all duties in keeping with the Company’s core values, policies and all applicable regulations.
· Bachelor’s degree or equivalent in the life sciences or related field required. Project management training (for example PMP Certification) is desirable.
· At least 5 years of experience in clinical study management. Experience conducting global Ph 1-3 clinical trials in the pharmaceutical, biotechnology, diagnostics industry, and/or CRO setting is desirable.
· A strong working knowledge of clinical trial operations, clinical study design, protocol development, study enrollment planning and management, and site monitoring.
· Demonstrated experience in selection and management of CROs and other vendors/suppliers.
· A solid understanding of the relevant parts of ICH, GCP, CFR, EMA, as well as HIPAA regulations and GDPR.
· Demonstrated ability to prioritize tasks in order to meet deadlines and adapt to changing priorities in a fast-paced, cross-functional team environment.
· Excellent time management & project coordination skills along with proficiency in the use of software tools including MS Word, MS Excel, SmartSheet project planning, and MS Project to support project planning activities.
· Proficiency in study budget forecasting and management.
· Excellent written and verbal communication, interpersonal, and decision-making skills.
· Team player with strong interpersonal and communication skills.
· Excellent verbal and written communication skills, including ability to present the rationale, data, issues, and solutions.
· Positive and professional approach.
· Strong problem-solving skills with a high level of creativity and productivity, and a bias to action.
The employee must be able to perform the essential functions of the position satisfactorily and, if requested, reasonable accommodations will be made to enable employees with disabilities to perform the essential functions of their job, absent undue hardship. The Employer retains the right to change or assign other duties to this position.
In addition to a competitive compensation package with stock options, we also offer a comprehensive benefits package for our employees and their families, which includes medical, dental, vision, life, disability and a 401(k) plan.
This position may be based in either our San Diego or Boston offices.