Director Regulatory Affairs

Klein-Hershheader.jpg

Director Regulatory Affairs


POSITION DESCRIPTION

Position         Director Regulatory Affairs          

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. 


ROLE: DIRECTOR REGULATORY AFFAIRS

resTORbio is currently growing its Regulatory team to support global development and is searching for a Director, Regulatory Affairs.  This individual will be responsible for developing regulatory strategies and managing high-quality submissions to regulatory agencies through external consultants.  This position reports to the Vice President, Regulatory Affairs.


KEY RESPONSIBILITIES

  • Collaborate with VP, Regulatory Affairs to define and execute regulatory strategies to ensure product approvals consistent with corporate objectives and applicable regulations and guidelines.
  • Author regulatory documents and lead the preparation of regulatory submissions including meeting briefing packages, INDs, CTAs, annual reports, NDAs, MAAs
  • Coordinate with external publishing resources for on-time delivery of accurate, compliant, and high-quality regulatory submissions to regulatory agencies
  • Lead the preparation for regulatory agency meetings (e.g., Pre-IND, End-of-Phase 2, Type C, Pre-NDA/MAA)
  • Manage and ensure compliance with all reporting requirements, including annual and periodic reports.
  • Establish and maintain ClinicalTrials.gov postings for supported studies
  • Establish relevant processes and procedures to support the Regulatory Affairs activities
  • Participate in regulatory intelligence gathering activities and maintain knowledge of US and EU regulatory requirements

PROFESSIONAL EXPERIENCE / QUALIFICATIONS

  • Bachelor's degree in life sciences required; advanced degree preferred
  • Minimum of 8 years Regulatory Affairs experience
  • Evidence of successful submissions to FDA/EMA (e.g., INDs, briefing packages)
  • Demonstrated evidence of writing of regulatory documents (Module 1, Module 2, briefing packages, fast track designation applications, etc.)
  • Knowledge of FDA and ICH regulations and guidelines a must
  • Excellent oral and written communications skills as well as the ability to build cross-functional relationships, work collaboratively and influence effectively at all levels cross functionally
  • Ability to work well under pressure and adhere to deadlines
  • Excellent interpersonal skills
  • Strong project management skills and drive for excellence

COMPENSATION

An attractive compensation package commensurate with this senior leadership role will be provided.


HIRING EXECUTIVE PROFILE

Karen-Jauregui.png

Karen Jauregui
Vice President of Regulatory Affairs

Karen Jauregui brings to resTORbio more than 20 years of global drug development experience including regulatory affairs, clinical operations, quality assurance and project management.  She has worked in many therapeutic areas including anemia, imaging, CNS, GI and osteoarthritis, as well as with pediatric and orphan indications.  She has extensive experience interacting and negotiating with Regulatory Authorities including FDA, EMA and PMDA.  Most recently Karen served as Vice President of Regulatory Strategy at Akebia Therapeutics where she was responsible for global regulatory strategy and planning of early and late stage compounds.  Previously, Karen served as Director of Global Regulatory Affairs at EMD Serono providing regulatory oversight to development programs in various therapeutic areas.   She also served in multiple roles of increasing responsibility at Repligen Corporation including Senior Director of Clinical Operations and Regulatory Affairs.  Karen received her B.S. in Biology and Medical Technology from the State University of New York at Plattsburgh.


TO APPLY PLEASE CONTACT A KLEIN HERSH REPRESENTATIVE

Jacob Kind
Senior Director of Regulatory Affairs
220 Gibraltar Road, STE 150
Horsham, PA 19044
Phone: 215-830-8828
Email: jkind@kleinhersh.com

Zach Spitz
Director of Regulatory Affairs
220 Gibraltar Road, STE 150
Horsham, PA 19044
Phone: 267-948-1429
Email: zspitz@kleinhersh.com

Michael Perkel
Associate Director of Regulatory Affairs
220 Gibraltar Road, STE 150
Horsham, PA 19044
Phone: 267-948-1446
Email: mperkel@kleinhersh.com

Nicole Brueckman
Research Associate
220 Gibraltar Road, STE 150
Horsham, PA 19044
Phone: 267-948-1431
Email: nbrueckman@kleinhersh.com


Senior CMC Specialist

Klein-Hershheader.jpg

Senior CMC Specialist


POSITION DESCRIPTION

Position           Senior CMC Specialist
Company        resTORbio, Inc.
Location         Cambridge, 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

  • Participation in outsourced API and DP manufacturing processes
  • Participation in solving potential manufacturing processes challenges
  • Participation in oversight of manufacture of regulatory starting materials, intermediates and API in support of clinical trial material requirements and commercial process validation
  • Participation in ensuring that regulatory starting materials and API process development and manufacturing activities are conducted in compliance with good manufacturing practices and applicable regulatory requirements by proactively co-overseeing process development and manufacturing campaigns
  • Participation in ensuring that DP process development and manufacturing activities are conducted in compliance with good manufacturing practices and applicable regulatory requirements by proactively co-overseeing process development and manufacturing campaigns
  • Review API and DP batch records, analytical methods validation plans, process validation plans and protocols, manufacturing campaign reports.
  • Contribute to CMC regulatory submission as a subject matter expert
  • Prepare technical reports, patent application content, publications and oral presentations as necessary
  • Communicate progress and strategy in various forums including reports, presentations and open discussions

PROFESSIONAL EXPERIENCE / QUALIFICATIONS

  • PhD in synthetic organic chemistry and or DP formulation development or Pharmacy degree and least 5 years’ experience in pharmaceutical industry or similar M.S. degree with at least 8 years of experience
  • In-depth knowledge of medicinal/synthetic organic chemistry, chemical process development,
  • DP formulation process development and efficient process throughput concept
  • Experience working in a virtual model setting is a plus
  • Proven track record of successfully overseeing API chemistry program and DP process development
  • Experience working with analytical and formulation development, quality assurance and control teams
  • Experience with contributing to CMC sections of clinical trial and marketing applications worldwide
  • Excellent interpersonal, verbal and written communication skills
  • Comfortable in a fast-paced environment and able to adjust based upon changing priorities

HIRING EXECUTIVE PROFILE

Abdellah.png

Abdellah Sentissi
Head of CMC

Dr. Sentissi joined resTORbio as Head of CMC and Pharmaceutical Development in January 2017. Dr. Sentissi brings more than 30 years of experience leading manufacturing and quality functions for biotechnology companies. During his career working with several companies as a consultant or as functional leader, Dr. Sentissi led several products through scale-up, registration and validation runs, facility validation and all related quality assurance and control functions. Dr. Sentissi earned his Pharmacy degree from the School of Medicine and Pharmacy-University Paul Sabatier, Toulouse, France and a Ph.D. in Biomedical Sciences from Northeastern University. He also holds multiple French National Certifications in Medical Pathology, Immunology, Hematology and Parasitology from the School of Medicine and Pharmacy-University Paul Sabatier and the School of Pharmacy of Montpellier, France.

https://www.linkedin.com/in/abdellah-sentissi-43ba718/


TO APPLY PLEASE CONTACT A KLEIN HERSH REPRESENTATIVE

Jared Kaleck
Client Partner
220 Gibraltar Road, STE 150
Horsham, PA 19044
Phone: 215-830-9229
Email: jkaleck@kleinhersh.com


Marc Miller
Client Partner
220 Gibraltar Road, STE 150
Horsham, PA 19044
Phone: 215-830-0294
Email: mmiller@kleinhersh.com


Nicole Brueckman
Research Associate
220 Gibraltar Road, STE 150
Horsham, PA 19044
Phone: 267-948-1431
Email: nbrueckman@kleinhersh.com


Director / Senior Director, Data Management

Klein-Hershheader.jpg

Director / Senior Director, Data Management


POSITION DESCRIPTION

Position         Director / Senior Director, Data Management

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. 


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.


KEY RESPONSIBILITIES

  • 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

EDUCATION

BS Life Sciences or Computer Science


COMPENSATION

An attractive compensation package commensurate with this senior leadership role will be provided.


HIRING EXECUTIVE PROFILE

Sarb_Shergill.png

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

Matt Azarva
Senior Director
220 Gibraltar Road, STE 150
Horsham, PA 19044
Phone:   215-830-9202
Email:  mazarva@kleinhersh.com

Barbara Fry
Research Associate
220 Gibraltar Road, STE 150
Horsham, PA 19044
Phone:   215-830-9211
Email:  bfry@kleinhersh.com


Vice President Clinical Development

Klein-Hershheader.jpg

Vice President Clinical Development


POSITION DESCRIPTION

Position          Vice President Clinical Development
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.


ROLE: VICE PRESIDENT CLINICAL DEVELOPMENT

  • Responsible for the overall direction, planning, execution and interpretation of the clinical program.
  • Provide leadership to the clinical team and ensure that operational aspects of clinical studies are appropriately implemented to support scientific and medical objectives. Ensure high quality timely deliverables on clinical studies.
  • Evaluate preclinical data and determine whether and how it can be translated to humans.
  • Serve as a liaison with KOLs, PIs, in the academic / medical community.
  • Responsible for interpreting and communicating clinical results to the investment community and BOD.
  • Represent ResTORbio to medical communities and regulatory agencies across various therapeutic areas.
  • Collaborate with executive team to determine clinical goals.
  • Lead the clinical team to ensure protocols are scientifically sound and designed to answer appropriate questions.
  • Motivated to work in a fast-paced, highly accountable, small company environment. A "can do" and collegial professional who leads through influence and interpersonal skills.
  • Collaborate with regulatory colleagues to provide appropriate clinical input on all regulatory documents filed both in the United States and abroad.
  • Review/Edit CSRs, slide presentations of clinical data, manuscripts, abstracts, posters and oral presentations for accuracy, content and messaging.

*additional duties and responsibilities not listed here may be required 


PROFESSIONAL EXPERIENCE / QUALIFICATIONS

  • 2+ years of clinical development experience within the Pharmaceutical or Biotechnology setting; 5+ years of clinical experience.
  • Experience running a basic science lab (preferred).
  • Excellent written and verbal communications skills and ability to work in a collaborative team environment.

EDUCATION

M.D.


COMPENSATION

An attractive compensation package commensurate with this senior leadership role will be provided.


HIRING  EXECUTIVE PROFILE

Joan_Mannick.png

Joan Mannick, M.D.
Co-Founder, Chief Medical Officer

Dr. Mannick is Co-Founder and Chief Medical Officer of resTORbio. Prior to joining resTORbio, Dr. Mannick was Executive Director in the New Indications Discovery Unit of the Novartis Institutes of Biomedical Research where Dr. Mannick led the clinical program at Novartis that targets pathways regulating aging to treat aging-related conditions. Prior to joining Novartis in 2010, Dr. Mannick was a Medical Director at Genzyme working in multiple therapeutic areas. Prior to Genzyme, Dr. Mannick was a faculty member at Harvard Medical School and University of Massachusetts Medical School. Her NIH-sponsored laboratory focused on the role of protein S-nitrosylation in physiology and pathophysiology. Dr. Mannick received her A.B. from Harvard College and her M.D. from Harvard Medical School. She completed her residency in Internal Medicine at Brigham and Women’s Hospital and an Infectious Disease fellowship as part of the Harvard Combined Infectious Disease Program.


TO APPLY PLEASE CONTACT A KLEIN HERSH REPRESENTATIVE

Jesse Klein
Managing Partner
220 Gibraltar Road, Ste 150
Horsham, PA 19044
Phone: 267-948-1438
Email: jklein@kleinhersh.com

Jared Kaleck
Client Partner
220 Gibraltar Road, Ste 150
Horsham, PA 19044
Phone: 215-830-9229
Email: jkaleck@kleinhersh.com

Jeff Azarva
Director, Physician Recruitment
220 Gibraltar Road, Ste 150
Horsham, PA 19044
Phone: 267-948-1439
Email: jazarva@kleinhersh.com

Ethan Schwartz
Director, Physician Recruitment
220 Gibraltar Road, Ste 150
Horsham, PA 19044
Phone: 267-948-1438
Email: ESchwartz@kleinhersh.com

Matt Taitelman
Director, Physician Recruitment
220 Gibraltar Road, Ste
150 Horsham, PA 19044
Phone: 267-948-1445
Email: mtaitelman@kleinhersh.com

Ilysa Shorr
Physician Recruitment – (Support)
220 Gibraltar Road, Ste 150
Horsham, PA 19044
Phone: 267-948-1434
Email: ishorr@kleinhersh.com


Senior Manager, QA and Document Control

Klein-Hershheader.jpg

Senior Manager, QA and Document Control


POSITION DESCRIPTION

Position         Senior Manager, QA and Document Control

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. 


ROLE: SENIOR MANAGER, QA AND DOCUMENT CONTROL

resTORbio is currently growing its Quality Assurance team and is searching for a Sr. Manager/ Associate Director of Quality Assurance.  This individual will be responsible for developing the Quality Management System and managing vendor audits.  This position reports to the Vice President, Regulatory Affairs.


PROFESSIONAL EXPERIENCE / QUALIFICATIONS

  • Build the Quality Management System to ensure regulations are adhered to and industry best practices are followed.
  • Independently initiates and manages the generation, review and approval of SOPs in compliance with applicable regulatory requirements.  Leads batch record review, product disposition / release, change control, investigations into deviations and execution of CAPAs.
  • Provides guidance pertaining to current GMPs, GCPs and GLPs and apply updates to the Quality System.
  • Supports GxP training of functional areas and contributes to the development of appropriate training for internal and external personnel.
  • Leads and manages quality with external vendor partners.  Devises GxP audit schedule, oversees execution of audit plans and audits, reviews audit reports, and tracks corrective/preventive actions associated with key sites and contract service providers in accordance with applicable regulations, guidelines and SOPs.
  • Manages the internal audit programs.
  • Manages contractors/consultants
  • Ability to grow out the Quality Assurance function to support drug development candidates from pre-clinical to commercial.
  • Possess in-depth knowledge of GMP regulations, principles, concepts, industry practices and standards. GLP and GCP experience a plus.
  • 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.

EDUCATION

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.


COMPENSATION

An attractive compensation package commensurate with this senior leadership role will be provided.


HIRING EXECUTIVE PROFILE

Karen-Jauregui.png

Karen Jauregui
Vice President of Regulatory Affairs

Karen Jauregui brings to resTORbio more than 20 years of global drug development experience including regulatory affairs, clinical operations, quality assurance and project management.  She has worked in many therapeutic areas including anemia, imaging, CNS, GI and osteoarthritis, as well as with pediatric and orphan indications.  She has extensive experience interacting and negotiating with Regulatory Authorities including FDA, EMA and PMDA.  Most recently Karen served as Vice President of Regulatory Strategy at Akebia Therapeutics where she was responsible for global regulatory strategy and planning of early and late stage compounds.  Previously, Karen served as Director of Global Regulatory Affairs at EMD Serono providing regulatory oversight to developmentprograms in various therapeutic areas.   She also served in multiple roles of increasing responsibility at Repligen Corporation including Senior Director of Clinical Operations and Regulatory Affairs.  Karen received her B.S. in Biology and Medical Technology from the State University of New York at Plattsburgh. 


TO APPLY PLEASE CONTACT A KLEIN HERSH REPRESENTATIVE

Tom Hayes
Senior Director, Quality Assurance
220 Gibraltar Road, Ste 150
Horsham, PA 19044
Phone:   267-948-1440
Email:  thayes@kleinhersh.com

Ilysa Shorr
Physician Recruitment – (Support)
220 Gibraltar Road, Ste 150
Horsham, PA 19044
Phone:   267-948-1434
Email:   ishorr@kleinhersh.com


Senior Director, Clinical Operations

Klein-Hershheader.jpg

Senior Director, Clinical Operations


POSITION DESCRIPTION

Position      Senior 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.


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.


KEY RESPONSIBILITIES

  • 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%.

KEY COMPETENCIES

  • 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.

EDUCATION

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.


COMPENSATION

An attractive compensation package commensurate with this senior leadership role will be provided.


HIRING EXECUTIVE PROFILE

Sarb_Shergill.png
 

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:

Lonnie Brantz
Senior Director of Clinical Operations and Project Management
220 Gibraltar Road, Ste 150
Horsham, PA 19044
Phone: 267-948-1433
Email: lbrantz@kleinhersh.com


Jim Sonnon
Associate Director, Clinical Operations
220 Gibraltar Road, Ste 150
Horsham, PA 19044
Phone: 267-387-0090
Email: jsonnon@kleinhersh.com


Ilysa Shorr
Clinical Operations – (Support)
220 Gibraltar Road, Ste 150
Horsham, PA 19044
Phone: 267-948-1434
Email: ishorr@kleinhersh.com