Senior Clinical Project Manager/Associate Director
Position Senior Clinical Project Manager/Associate Director Clinical Operations
Company resTORbio, Inc.
Location Boston, MA
resTORbio, Inc. (NASDAQ: TORC, $482M mkt cap) is a clinical-stage biopharmaceutical company focused on helping people live healthier longer through the development and commercialization of novel therapeutics for the treatment of aging-related diseases. resTORbio’s lead program is targeting the selective inhibition of TORC1 - an evolutionary conserved pathway that contributes to the decline in function of multiple organ systems, including the immune, cardiac and neurologic systems. resTORbio program has demonstrated in several clinical trials, including a randomized, placebo-controlled trial, the potential to treat multiple diseases of aging for which there are no approved therapies. RTB101, resTORbio’s lead drug candidate is a selective, orally administered, TORC1 inhibitor currently being tested in a Phase 2b clinical trial as a first in-class immunotherapy for reducing the incidence of respiratory tract infections in the elderly by enhancing the function of the immune system. The company expects to develop RTB101 for additional aging-related indications such as heart failure or neurodegenerative diseases.
Manage and lead the day-to-day operations of assigned study to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements.
Utilizes KPI and other metrics to proactively manage study deliverables and performance of CROs.
Conduct study monitoring visits and co-monitoring visits as needed.
Provide regular updates of study progress to the VP of Clinical Operations and other team members as appropriate.
Proactively identify and resolve issues that arise during study conduct; manage escalation of study-related issues.
Lead development of study plans and systems (recruitment plan, IXRS, EDC etc.) set-up; participate in preparation and ensure operational excellence of protocol, CRF, CSR and other key study team deliverables.
Implement appropriate systems, standards and processes to ensure quality at the level of investigative sites, vendors and data; maintain clinical study files per ICH guidance.
Lead preparation of vendor requirements and project scope and selection of study vendors; effectively manage interactions with vendor study team
Lead feasibility assessment and selection of countries and sites for study conduct.
Oversee the clinical aspects of timely data cleaning, data analysis and the availability of top line results; participate in data reviews and review of statistical analysis plans.
Author, audit and/or edit written summaries of data reports, presentations, training material, and study documents (including pharmacy, laboratory, and operations manuals).
Ensure set-up and implementation of effective investigator and site monitor training; coordinate operational and therapeutic area training for internal and external study team members .
Provide oversight and direction to study team members, including vendors, for study deliverables.
Coordinate with finance to track the financial status against budget.
Develops and maintains relationships with external vendors.
Collaborates with consultants and contractors to Research and Development.
Participate in the development and implementation of clinical operations standard operating procedures and best practices within the team.
PROFESSIONAL EXPERIENCE / QUALIFICATIONS
Requires at least 5-10 years of experience in clinical research operations, experience working within a small biotech environment is a plus.
Productivity/Organizing/Planning – Must be proactive and self-disciplined and meets deadlines, demonstrates effective use of time, and handles multiple assignments simultaneously.
Experience in managing one or more clinical studies (Phase I-III).
Ensures adherence to standard operating procedures, good clinical practice, and FDA regulations with strong understanding of inspection readiness.
Experienced in Good Clinical Practice (GCP) and is able insure implementation within any clinical study.
Demonstrated knowledge and experience in the regulatory aspects of pharmaceutical development, including protocol implementation, data collection and reporting, and understands preparation of regulatory submissions including Investigational New Drug (IND) and New Drug Applications (NDA) specifically for FDA and EMA.
Demonstrated experience in study management/monitoring and data management, working with, and negotiating with Clinical Research Organizations (CROs).
Demonstrated ability to work independently with exceptional organization and attention to detail.
Excellent written communication and presentation skills.
Comfortable being both an individual contributor and team player.
Excitement about the vision of resTORbio.
TO APPLY PLEASE CONTACT HR AT resTORbio