Senior Director, Clinical Operations
Position Senior 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.
ROLE: SENIOR DIRECTOR, CLINICAL OPERATIONS
resTORbio is looking for an experienced Clinical Operations Leader to join our team at our Boston, Massachusetts offices. Reporting to the VP, Clinical Operations, the successful candidate will provide operational leadership and expertise in the implementation and execution of clinical study programs, ensuring the timely completion of deliverables through the development and management of the project timelines and budgets. In conjunction with the VP, Clinical Operations and with cross-functional project team members, the Sr. Director, Clinical Operations is accountable for successful operational delivery of all studies within the Clinical Development Plan (CDP) through the program lifecycle (from planning, execution, data delivery and inspection planning and support activities) The Sr. Director of Clinical Operations, must have experience managing and providing oversight of clinical studies outsourced to third party vendors (CROs, central labs, imaging vendors, IRT, clinical supplies etc.) and be able to effectively manage interactions between other functional groups. The individual will also be responsible for building and maintaining relationships with clinical investigators/advisors/thought leaders. Additionally, the individual collaborates with key stakeholders internally and externally to understand the global therapeutic landscape and leverages this knowledge for the benefit of the program (eg
establishing geographic recruitment strategies) and has deep understanding of the operational
considerations when executing studies globally.
- Responsible and accountable for one or more clinical studies with emphasis on oversight of operational activities globally
- Leverages resources, expertise and knowledge across projects, including specific operational strategies for executing clinical studies globally
- Oversees and coordinates budgetary activities for assigned programs including study budget creation, forecasting, accruals reporting and invoice approval. Develops and manages timelines using MS Project.
- Translates corporate and product development goals into relevant, tangible and measurable objectives for the operational team and third party vendors and drives optimal delivery.
- Leads clinical operations strategic planning activities for clinical programs and translates strategic decisions into actionable operational plans.
- Leads the budget negotiation process and finalization with key clinical vendors. This role will be accountable to Senior Management for ensuring studies stay within their approved clinical project budgets.
- Accountable for management of all clinical research activities including proactive identification of work streams and dependencies, key risk indicators, resources and milestones
- Manage clinical trial implementation with clinical sites, external consultants and CRO personnel to ensure timely implementation of clinical studies in accordance with GCP regulatory requirements.
- Leads the operational selection of various vendors and the review of proposal requests.
- Works with in-house functional group leads and external advisors with regards to clinical study operational issues including safety reporting and processing and study drug supply plans, cross- functional communication/interaction plan and monitoring.
- Manages the progress of clinical studies and ensures adherence to the protocol, timelines, and budget. This includes reviewing site recruitment, initiation and patient enrollment progress and review and act on trending reports.
- Develop and manage clinical trial budgets; proactively provide senior management with necessary updates on progress and changes in scope, schedule, and resources in a timely manner.
- Collaborate with the CMO/VP Clinical Development to generate high quality clinical study reports, investigator brochures, clinical protocols, publications and presentations of clinical study results.
- Prepare and deliver effective presentations to the Project Team, Senior Management, Board members and external parties.
- Provides oversight of CROs using relevant metrics and tools and monitors progress toward Clinical Operations objectives.
- Oversees contracting and budget-related activities for vendors and clinical trial sites.
- Develops key study documents including informed consent forms, study manuals (including operational manuals), study plans (communication, escalation, oversight) and tools etc.
- Participates in developing the feasibility and site selection strategy.
PROFESSIONAL EXPERIENCE / QUALIFICATIONS
- Leads inspection readiness activities for FDA or other regulatory authorities as appropriate.
- Minimum 10+ years relevant clinical development experience.
- Minimum 5 years’ experience in Clinical Operations line management,
- High proficiency in clinical studies involving complex design issues (e.g., multiple arms, crossover, double blind, and multi-center), in all phases of pre-approval clinical trials
- Must be a demonstrated self-starter and team player with strong interpersonal skills.
- Must have lead inspection readiness activities
- Strong analytical and problem-solving skills
- Must be able to travel up to 30%.
- Interpersonal Skills – Strong interpersonal and project management skills.
- Communication Skills - Excellent oral, written communication, and presentation skills utilizing all available technologies.
- Productivity/Organizing/Planning – Must be proactive and self-disciplined and meets deadlines, demonstrates effective use of time, and handles multiple assignments simultaneously.
- Collaboration & Teamwork – Advanced competence in collaboration and teamwork.
- Relationship Management – Must be able to influence and manage the relationship with CROs and other service providers that includes clinical study site staff, such as investigators, study coordinators, pharmacists, as well as other relevant functional team members.
B.S, M.S Degree (preferred) in science or a health related field is required with direct experience leading to the delivery of an IND, CTA, NDA and MAA.
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.
TO APPLY, PLEASE CONTACT A KLEIN HERSH REPRESENTATIVE:
Senior Director of Clinical Operations and Project Management
220 Gibraltar Road, Ste 150
Horsham, PA 19044
Associate Director, Clinical Operations
220 Gibraltar Road, Ste 150
Horsham, PA 19044
Clinical Operations – (Support)
220 Gibraltar Road, Ste 150
Horsham, PA 19044