Receptionist & Office Administrator

resTORbio logo Final.jpg

Receptionist & Office Administrator


POSITION DESCRIPTION

Position           Receptionist & Office Administrator
Company        resTORbio, Inc.
Location         Boston, MA
Website           https://www.restorbio.com/


COMPANY BACKGROUND

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.


KEY RESPONSIBILITIES

  • Greets visitors

  • Manages the main phone lines, answer calls, direct callers, provide assistance, and takes concise telephone messages.

  • Coordinates and assist guests with requests & any IT setup for presentation/webinars.

  • Maintains a tidy, welcoming, and comfortable environment in reception, the kitchen, the conference rooms, and all other common spaces.

  • Maintains the inventory for office/kitchen supplies, process weekly PeaPod/Staples orders, and ensure areas are well stocked.

  • Main point of contact for shipping (incoming/outgoing), coordinate scheduling of courier services, and overseeing mail pickup and distribution for the office.

  • Organizes and order all company lunches, as well as smaller internal lunch meetings.

  • Schedule company meetings, recurring/standard meetings, events, etc. Work with meeting owners to reschedule any conflicts and track attendee list.

  • Manages all service requests and office deliveries.

  • Printers - maintains toner and equipment, resolves any issues with vendor.

  • Manages conference room calendars.

  • Helps with on-boarding of New Hires.

  • Assists other VP, People, Office Manager and other employees with special/ad hoc tasks that may arise from time to time.


PROFESSIONAL EXPERIENCE / QUALIFICATIONS

  • Communicate effectively and professionally both internally and externally.

  • Demonstrate ability to set priorities while handling multiple projects.

  • Excellent administrative and organized skills.

  • Proficient user of MS Office (Excel, Word, PowerPoint, Outlook).

  • Strong written and verbal communication skills.

  • Minimum of HIgh School Diploma; Associates Degree or higher preferred.

  • Excellent attention to detail and diligence in fast-paced, deadline driven environment.

  • Demonstrates initiative.

  • Comfortable being both an individual contributor and team player.

  • Excitement about the vision of resTORbio.



TO APPLY PLEASE CONTACT HR AT resTORbio

hr@restorbio.com


Senior Clinical Project Mgr/Associate Director Clinical Operations

resTORbio logo Final.jpg

Senior Clinical Project Manager/Associate Director

Clinical Operations


POSITION DESCRIPTION

Position           Senior Clinical Project Manager/Associate Director Clinical Operations
Company        resTORbio, Inc.
Location         Boston, MA
Website           https://www.restorbio.com/


COMPANY BACKGROUND

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.


KEY RESPONSIBILITIES

  • 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

hr@restorbio.com


Head of Clinical QA/GCP

resTORbio logo Final.jpg

Head of Clinical QA/GCP


POSITION DESCRIPTION

Position           Head of Clinical QA/GCP
Company        resTORbio, Inc.
Location         Boston, MA
Website           https://www.restorbio.com/


COMPANY BACKGROUND

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.


KEY RESPONSIBILITIES

  • Develop strategy and provide quality/compliance leadership across the pipeline.

  • Develop and implement clinical quality (GCP) systems.

  • Identifies potential systemic gaps and coordinates with the appropriate stakeholder to ensure timely remediation.

  • Develop and successfully implement master auditing plans and inspection and compliance strategies governed by Good Clinical Practices (GCPs), Good Laboratory Practice (GLP) and applicable regulations and guidance.

  • Ensure a high level of quality and consistency across the studies and interact with various groups including CRO’s and investigator sites.

  • Accountable for the operational quality support for clinical trials worldwide. Conducts audits of external vendors, CROs, and clinical sites.

  • Provide guidance on investigations, root cause analysis of compliance issues, CAPAs, and deviations related to GCP. Provide the appropriate metrics for tracking overall reporting requirements.

  • Act as an advisor on compliance related matters and implement corrective and preventive actions, enable program team to be inspection ready and support a culture of sustainable compliance.

  • Lead inspection readiness effort.

  • Write SOPs and lead team training.

  • Review clinical trial documents including Trial Master Files (TMFs).

  • Oversee document control and implementation of electronic document management system.


PROFESSIONAL EXPERIENCE / QUALIFICATIONS

  • At least Bachelor’s Degree in Science or related field.

  • 10+ years' experience in the biotech/pharma industry (or with a mixed medical device / pharma clinical quality background).

  • 5+ years' recent experience leading quality assurance for clinical research, including phase III and pre-approval inspection readiness with FDA and EMEA.

  • Strong knowledge of FDA and ICH E-6 for Good Clinical Practice (GCP), and 21CFR Part 11 with respect to clinical processes and systems.

  • Excellent attention to detail and diligence in fast-paced, deadline driven environment

  • Strong written and verbal skills.

  • Desire to learn and be a part of a fast-growing company/dynamic team.

  • Demonstrates initiative and be solution oriented.

  • Comfortable being both an individual contributor and team player.

  • Excitement about the vision of resTORbio.



TO APPLY PLEASE CONTACT HR AT resTORbio

hr@restorbio.com


Sr. Manager/Associate Director of Quality Assurance

resTORbio logo Final.jpg

Senior Manager/Associate Director of Quality Assurance


POSITION DESCRIPTION

Position           Sr. Manager/Associate Director of Quality Assurance
Company        resTORbio, Inc.
Location         Boston, MA
Website           https://www.restorbio.com/


COMPANY BACKGROUND

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.


KEY RESPONSIBILITIES

  • Implement the Quality Management System to ensure regulations are adhered to and industry best practices are followed.

  • Independently initiate and manage the generation, review, and approval of SOP’s in compliance with applicable regulatory requirements.

  • Lead batch record review, product disposition / release, change control, investigations into deviations, and execution of CAPAs.

  • Provide guidance pertaining to current GMPs and apply updates to Quality System.

  • Support GxP training of functional areas and contributes to the development of appropriate training for internal and external personnel.

  • Oversee execution of external audit program: review audit reports and track corrective/preventive actions in accordance with applicable regulations, guidelines and SOPs.

  • Manage the internal audit programs.

  • Manage contractors/consultants.


PROFESSIONAL EXPERIENCE / QUALIFICATIONS

  • Bachelor’s degree with minimal 7-10 years of professional experience in the Biotech or Pharma industries including at least 5 years in quality assurance & regulatory compliance.

  • Possess in-depth knowledge of GMP regulations, principles, concepts, industry practices and standards. GLP and GCP experience a plus.

  • Ability to contribute to the Quality Assurance function to support global drug development candidates from pre-clinical to commercial.

  • Understanding of domestic and international regulatory requirements.

  • Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful, and efficient.

  • Demonstrated ability to translate a practical strategy into action.

  • Outstanding communication skills (interpersonal, verbal and written).

  • Strong leadership and management skills.

  • Excellent teamwork and collaboration skills.

  • Ability to travel as required for audits.



TO APPLY PLEASE CONTACT HR AT resTORbio

hr@restorbio.com