Prolacta is the pioneer in human milk-based nutritional products for premature infants in the neonatal intensive care unit (NICU). Prolacta believes that there is no adequate replacement for human breast milk and, as such, we believe infant nutritional products should be human milk-based. As a privately held, scientifically driven company, committed to improving premature infant nutrition, we are using human milk to change the standard of care in the NICU. Prolacta operates and/or owns milk banks that provide the starting material for the products Prolacta sells.
The incumbent is responsible for supporting and managing the execution of the day to day functions in the Clinical Research and Development area. These functions include helping to develop study protocols, organizing study meetings, monitoring the studies, keeping track of study progress, collecting the data, and helping to summarize the study data and produce appropriate publications. Finally, the incumbent will be responsible for explaining the preparation and use of Prolacta products to study sites and be available to respond to investigators and their staff.
Primary Duties and Responsibilities
• Provide management support for Prolacta's clinical research program.
• Provide technical support for inquiries on Prolacta's products, particularly in regards to those associated with clinical research centers.
• Oversee the data collection and management of the data from Prolacta’s clinical research program
• Support IND and other regulatory filings for Prolacta’s studies that require such regulatory support
Job Requirements and Qualifications
RN or Bachelor's degree in a biological science with a minimum of 10-15 years of clinical research experience is acceptable.
• Reasonable knowledge of the workings of clinical studies based on at least 3-5 years’ experience in working with such research in a pharmaceutical/biotechnology environment
• Good documentation skills required
• Experience in a hospital setting a plus,
• Experience managing CROs required
Other Knowledge, Skills and Abilities
Previous experience working in either an academic or commercial clinical trials environment as part of an Investigational New Drug Application necessary
Knowledge of FDA and other regulatory agency rules and regulations required.
Able to create and manage a budget
Ability to work without supervision
Effectively interview and select candidates
Handle conflict management and bring resolution
Effective relationship building skills
Ability to produce and present clear, concise and professionally written communications and presentations
Performance Management, effective coaching and directing of others
Positive attitude and motivation
Ability to operate in a complex matrix environment
Visionary and forward-thinking
High level of business acumen
Strong PC skills, MS Outlook, Word, etc.
Must be able to work under pressure, meet deadlines, and be flexible when working on multiple projects simultaneously
Strong Critical thinking and decision-making skills
Strong business ethics
Work Environment (Location, travel, shift, on-call, etc.)
About 40% time in the US, and possibly sporadic overseas travel.