- Manage and oversee clinical operation strategies and tactical implementation of studies, including oversight of Clinical Research Organizations (study/enrollment/protocols), vendors, investigators and the coordination of activities to meet department and corporate timelines;
- Lead efforts to identify, evaluate and manage budgetary requirements for clinical operations and 3rd party vendors, including scope of works (SOW), request for proposals (RFP) and specifications;
- Ensures timely and effective communication and updates to both internal and external stakeholders to ensure efficient execution of the study management process according to study protocols and Good Clinical Practice (GCP);
- Plan and implement clinical development program, including scenario planning, forecasting of timelines, estimation of resources and budgets;
- Manages and participates in investigator meetings, scientific congresses, etc., as applicable;
- Establish and manage the development and/or review of key documents, including abstracts, presentations, protocols and write reports and regulatory documents for IND, BLA and de-novo submissions;
- Create internal Standard Operating Procedures and Clinical work practice documentation; Implement these plans for Clinical operations to operate in accordance with FDA and international regulations/guidelines;
- Oversees all aspects of study level execution by the CTMs and CTAs, including but not limited to: supervising site start-up and patient enrollment, clinical monitoring, compliance and data flow metrics from clinical sites, CROs and central labs;
- Participates in preparation for, and conduct of, Health Authority inspections and internal QA audits; ensuring that the study team operates in a constant state of inspection readiness and in compliance with FDA, EMA, GCP, and ICH guidelines
- Advanced health, life or biomedical sciences or equivalent educational experience is preferred (MS/MA, Ph.D, PharmD);
- Minimum of 5 years experience in the biotechnology and/or pharmaceutical industry, Academic Research Organization or Contract Research Organization with a minimum of 3 years direct experience planning and managing clinical trials;
- Significant experience with core management roles in the conduct or management of Phase I-IV multi-site clinical trials and associated budgets; cell, gene therapy or biologics experience preferred;
- Strong working knowledge of medical terminology, physiology and pharmacology and excellent understanding of applicable U.S. and international guidelines and regulations;
- Ability to build strong internal and external relationships both within and across functional teams to engage high performance;
- Exposure to CTM systems, EDC systems (eClinical, Medidata RAVE, Veeva, InForm) and Safety/ Pharmacovigilance databases (ARGUS)
Rion is a clinical-stage biotechnology company based in Rochester, Minnesota. Rion was founded as a Mayo Clinic Employee Entrepreneurial Program startup company. Rion’s mission is to develop clinically impactful and accessible therapies using innovative regenerative medicine technologies based on extracellular vesicle science. Our proprietary exosome platform has the ability to address significant unmet patient needs in many fields of medicine; accordingly, we are actively pursuing clinical programs in wound healing, cardiovascular diseases, and women’s health. Our ultimate mission is to deliver cutting edge solutions accessible to any patient in need, anywhere in the world.
Rion recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue career path their goals, both at work and in their personal lives.
We provide a very competitive compensation package with a unique culture focusing on development and wellbeing of our staff. Below are some of the benefits offered by Rion:
- Full Health, Dental and Vision Insurance for employees and their dependents.
- Health Insurance including PPO or High Deductible Health Plan with Health Savings Account.
- Dental Insurance
- Vision Insurance
- Flexible Spending Accounts (FSA)
- 401k or IRA Retirement Savings
- Life Insurance basic life and supplemental life insurance options for self, spouse, children
- Short and Long-Term Disability Insurance
- Paid Time Off
- Paid Holidays
- Parking benefits
Rion is an equal opportunity employer and complies with all applicable federal, state and local fair employment practices laws. Rion strictly prohibits and does not tolerate discrimination against employees, applicants or any other covered persons because of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including gender nonconformity and status as a transgender or transsexual individual), age, physical or mental disability, citizenship, past, current or prospective service in the uniformed services, genetic information, marital status, AIDS/HIV status, smoker/nonsmoker, and occupational pneumoconiosis or any other characteristic protected under applicable federal, state or local law.
Please send your resume and cover letter to email@example.com.