Director / Senior Director, Data Management
Position Director / Senior Director, Data Management
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.
ROLE: DIRECTOR / SENIOR DIRECTOR, DATA MANAGEMENT
resTORbio is looking for an experienced Data Management leader to join our team at our Boston, Massachusetts offices. The individual will be accountable for the global delivery, integrity and quality of clinical data across the resTORbio portfolio, while adhering to target timelines, budget and quality. The individual will also provide leadership of the evolution of resTORbio’s data processes, systems and organization in alignment with corporate goals. The individual will also provide hands-on support in planning and executing clinical trials and working with external vendors and the resTORbio team.
Reporting to the VP Clinical Operations.
- Responsible for assessing in house data management needs and driving the selection and implementation of an in-house data management solutions including developing policies and procedures
- Supports the development of request for proposals (RFPs) for external vendor cross-functional/organizational contracts, evaluates and approves service level agreements. Review external vendor cross-functional/organizational contracts and budget for appropriateness to the project when requested
- Recruit and supervise personnel as appropriate to meet the service obligations of the organization
- Oversight of build, validation, and maintenance of clinical trial databases in accordance with ICH/GCP guidelines and current regulatory requirements. Responsible for clinical data management activities for outsourced studies
- Ensures data management activities including milestones and deliverable for clinical trials are completed with quality and timelines are met within budget and in accordance with regulatory requirements. Utilizes KPIs and metrics to monitor study progress and performance of CROs/vendors
- Oversees service providers to perform core data management functions including IWR/IVRS, PRO, central imaging reads, CRF, edit check and CRF completion guidelines development, user acceptance testing, data cleaning, reviewing listings, and database locking procedures
- Establish inter- and intradepartmental processes to improve the efficiency and quality of data processing
- Develops positive partnerships with CROs and ensures a high standard of deliverables are maintained within budget and timelines
- Prepares and maintains timelines for the assigned studies, and communicates to management any issues so that appropriate actions can be taken.
- Prepares status reports and updates for senior management as required
- Approves data management plans for completeness and accuracy of required documentation according to SOP.
- Oversees collection, review and archiving of the DMP and other pertinent documents for all assigned studies. Provides input into CDMS requirements, assuring protocol requirements are met. Oversees and performs UAT on CDMS components as needed.
- Supports validation efforts to minimize the company’s exposure to regulatory risk by validating all electronic data streams and systems in support of organizational objectives
- Ensure inspection readiness in all DM related domains and activities.
PROFESSIONAL EXPERIENCE / QUALIFICATIONS
- 10-15 years of data management experience in a clinical research setting
- Demonstrated expertise in multiple software applications applicable to Data Management services.
- Demonstrated expertise in leading and supervising management level personnel and in providing guidance and mentoring with respect to managerial skills and competencies.
- Excellent organizational skills with ability to multi-task.
- Demonstrated ability to accurately identify and resolve problems.
- Recruit and selecting appropriately skilled and trained CDM candidates for employment as the needs of the organization change.
- Work with Medical Writing personnel in preparation of clinical study reports and other regulatory documents including IND, NDA, MAA etc.
- Effectively interact with senior members of other functional areas for strategic planning to ensure optimized clinical development in accordance with corporate objectives.
- Strong working knowledge and prior experience directly managing/overseeing service providers and CRO’s is mandatory.
- Knowledge of SAS and database programming
- Systems integration experience
BS Life Sciences or Computer Science
An attractive compensation package commensurate with this senior leadership role will be provided.
HIRING EXECUTIVE PROFILE
Sarb Shergill, Ph.D.
Vice President, Clinical Operations
Dr. Shergill joins resTORbio from Akebia Therapeutics, where she led global clinical operations, overseeing four large phase III cardiovascular outcomes studies, four Phase II studies (including studies in Japan) and several clinical pharmacology studies, as well as overseeing clinical research organization activities and managing the clinical budget.
Prior to joining Akebia Therapeutics in 2015, Dr. Shergill was an Associate Vice President of Clinical Research at Genzyme working in multiple therapeutic areas. During Dr. Shergill’s tenure at Genzyme, she led a global group of senior project leaders and led the clinical operations execution of more than 80 clinical trials (Phase I-IV). Dr. Shergill served as the Genzyme representative for many competent authority (FDA, EMA and MHRA) pre-inspection readiness initiatives as well as for regulatory inspections conducted on Genzyme products. Dr. Shergill also has experience working at a CRO and has investigator site level experience having worked in Canada for an academic teaching center running multiple studies in an ICU and multi-organ transplant setting. Dr. Shergill received her B.Sc. in Pharmacology from the University of Portsmouth, UK and her Ph.D. in Pharmacology from Liverpool John Moores University in the UK.