Marengo Therapeutics Inc
Senior Manager/Associate Director, Clinical Operations
Marengo Therapeutics Inc, Cambridge, Massachusetts, us, 02140
PLEASE: Local Candidates Only
Marengo Therapeutics is a pioneering first-in-class therapeutics that activates the right immune response to promote lifelong protection against cancer. Marengo has uncovered a novel approach to T cell activation by targeting the Vß TCR chain to unleash rapid, potent, and long-lasting anti-tumor immune responses safely and effectively. We’re leveraging our versatile, proprietary bispecific fusion protein platform to selectively deliver the right activation to the right T cell subsets, customizable to patient needs with its tunable properties, with an initial focus on advanced solid tumors and broad applicability beyond.
Marengo is driven by core values that guide our company’s mission and approach from the inside out: we demonstrate an unparalleled commitment to patients and their loved ones, we are confident in our science and our team, we operate with courage, and we creatively apply deep expertise to new ways of thinking with curiosity and imagination. With an exciting journey ahead and a tremendous opportunity for growth, now is the time to join the Marengo team and impact cancer patient care – are you ready to join the new frontier?
To learn more, visit marengotx.com.
Role:
Senior Manager/Associate Director, Clinical Operations
Overview:
The Senior Manager/Associate Director of Clinical Ops collaborates with clinical, regulatory, and development functions to execute clinical strategies and deliver successful operational outcomes across one or multiple clinical trials. The Senior Manager/Associate Director of Clinical Ops will work across the organization to ensure the on-time delivery of critical tasks within a clinical study. In addition to exceptional project delivery, we seek strong analytical skills, attention to detail, and leadership qualities that will influence our internal team and motivate our CRO partners.
Please note that this is an in-person, in-the-office role with some flexibility.
Who are we looking for?
You are an extremely driven and passionate individual seeking to be a part of the Clinical Operations group who has expertise in working on novel oncology compounds in various phases of clinical trials.
You are an energetic and passionate individual who likes to think outside of the box, challenge the norm, and is passionate about the company’s mission of discovering and developing new medications.
You are a resourceful self-starter and team player with a strong results orientation.
You can develop trusting relationships to gain support and achieve results at all levels of the organization.
What are we looking for?
A driven professional who knows how to work and contribute to an ever-changing working environment.
A collegial and collaborative individual who enjoys working in close partnership with leaders in the research, development, manufacturing, quality, clinical, and administrative areas of the company.
A willingness to learn new things, adapt to new ways, and go with the flow.
A person who thrives in a small company atmosphere.
Ability to determine task priority and maintain established deadlines.
What are we offering?
Affiliation within a growing, CARING, and collegial organization.
Being part of a passionate, involved, and cutting-edge Clinical Ops Team.
Exposure to pioneering science and the discovery of drugs to help treat patients in the oncology space.
Responsibilities:
Provide
clinical leadership to CROs
and other vendors. Oversee clinical systems and technical integrations for databases, CTMS, eTMF, central reading, and other trial execution and/or data collection platforms.
Oversight of study
start-up, study management, data cleaning, and study closeout activities. Provides leadership for developing and writing study protocols, study plans, CRFs, and informed consent forms. Plan, negotiate, and manage site budgets and facilitate the site contracting process. Oversight of study team and site training. Interact with clinical research investigators and sites. Management of study drug distribution and accountability processes and documentation. Responsible for final study files and documentation, including TMF, final TLFs, and final study data archival.
Develop and implement robust
contingency and issue management
plans to solve complex issues that impact study or program milestones.
Disseminate
clinical program communications
to all functional groups and lead program, study, and team meetings.
Cross-functional partnership across the R&D team
to ensure scientific and medical/development priorities are well integrated. Supports external vendor selection and management process and assists in developing RFPs and vendor oversight plans.
Responsible for the study budget and management of timelines.
Accountable for project-related efforts to deliver studies or programs, ensuring they are completed on time, within budget, and in compliance with SOPs, regulations, and ICH/GCP guidelines.
Education and Experience:
BA/BS degree in Health or Life Sciences required; MA/MS preferred.
Oncology therapeutic experience is strongly preferred, all stages with high complexity.
Minimum of 12+ years of clinical operations experience in a pharmaceutical, biotech, or CRO setting.
Solid understanding of the drug development process.
Competencies:
Adaptability:
Responds resourcefully, flexibly, and positively when faced with new challenges, transitions, and demands.
Collaboration:
Embodies and promotes collaboration and works effectively with others across the organization to achieve goals.
Execution:
Drives execution of strategic and operating plans while maintaining operational effectiveness.
Relationship Building:
Establishes and maintains strong relationships internally and externally.
Location:
Cambridge, MA (We are located in Lower Cambridge, called Cambridgeport)
When You Join Marengo, You Will Have:
Free parking, Cambridge location reachable by public transportation (Red Line).
Customized and competitive health coverage, including medical offered through BCBS (HMO/PPO), dental, and vision.
Flexible Spending Accounts for medical and dependent care expenses.
Eligible from the first day for 401K, no matching.
A robust package of Marengo-paid insurance coverage, including life insurance, short-term and long-term disability.
20 days of vacation and one personal day per year, in addition to 15 company holidays.
TO ALL AGENCIES:
Please, no phone calls or emails to any employee of Marengo about our openings. All resumes submitted by search firms/employment agencies to any employee at Marengo via email, the internet or in any form and/or method will be deemed the sole property of Marengo unless such search firms/employment agencies were engaged by Marengo for this position and a valid agreement with Marengo is in place. In the event a candidate who was submitted outside of the Marengo agency engagement process is hired, no fee or payment of any kind will be paid.
Marengo Therapeutics, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.
#J-18808-Ljbffr
Marengo Therapeutics is a pioneering first-in-class therapeutics that activates the right immune response to promote lifelong protection against cancer. Marengo has uncovered a novel approach to T cell activation by targeting the Vß TCR chain to unleash rapid, potent, and long-lasting anti-tumor immune responses safely and effectively. We’re leveraging our versatile, proprietary bispecific fusion protein platform to selectively deliver the right activation to the right T cell subsets, customizable to patient needs with its tunable properties, with an initial focus on advanced solid tumors and broad applicability beyond.
Marengo is driven by core values that guide our company’s mission and approach from the inside out: we demonstrate an unparalleled commitment to patients and their loved ones, we are confident in our science and our team, we operate with courage, and we creatively apply deep expertise to new ways of thinking with curiosity and imagination. With an exciting journey ahead and a tremendous opportunity for growth, now is the time to join the Marengo team and impact cancer patient care – are you ready to join the new frontier?
To learn more, visit marengotx.com.
Role:
Senior Manager/Associate Director, Clinical Operations
Overview:
The Senior Manager/Associate Director of Clinical Ops collaborates with clinical, regulatory, and development functions to execute clinical strategies and deliver successful operational outcomes across one or multiple clinical trials. The Senior Manager/Associate Director of Clinical Ops will work across the organization to ensure the on-time delivery of critical tasks within a clinical study. In addition to exceptional project delivery, we seek strong analytical skills, attention to detail, and leadership qualities that will influence our internal team and motivate our CRO partners.
Please note that this is an in-person, in-the-office role with some flexibility.
Who are we looking for?
You are an extremely driven and passionate individual seeking to be a part of the Clinical Operations group who has expertise in working on novel oncology compounds in various phases of clinical trials.
You are an energetic and passionate individual who likes to think outside of the box, challenge the norm, and is passionate about the company’s mission of discovering and developing new medications.
You are a resourceful self-starter and team player with a strong results orientation.
You can develop trusting relationships to gain support and achieve results at all levels of the organization.
What are we looking for?
A driven professional who knows how to work and contribute to an ever-changing working environment.
A collegial and collaborative individual who enjoys working in close partnership with leaders in the research, development, manufacturing, quality, clinical, and administrative areas of the company.
A willingness to learn new things, adapt to new ways, and go with the flow.
A person who thrives in a small company atmosphere.
Ability to determine task priority and maintain established deadlines.
What are we offering?
Affiliation within a growing, CARING, and collegial organization.
Being part of a passionate, involved, and cutting-edge Clinical Ops Team.
Exposure to pioneering science and the discovery of drugs to help treat patients in the oncology space.
Responsibilities:
Provide
clinical leadership to CROs
and other vendors. Oversee clinical systems and technical integrations for databases, CTMS, eTMF, central reading, and other trial execution and/or data collection platforms.
Oversight of study
start-up, study management, data cleaning, and study closeout activities. Provides leadership for developing and writing study protocols, study plans, CRFs, and informed consent forms. Plan, negotiate, and manage site budgets and facilitate the site contracting process. Oversight of study team and site training. Interact with clinical research investigators and sites. Management of study drug distribution and accountability processes and documentation. Responsible for final study files and documentation, including TMF, final TLFs, and final study data archival.
Develop and implement robust
contingency and issue management
plans to solve complex issues that impact study or program milestones.
Disseminate
clinical program communications
to all functional groups and lead program, study, and team meetings.
Cross-functional partnership across the R&D team
to ensure scientific and medical/development priorities are well integrated. Supports external vendor selection and management process and assists in developing RFPs and vendor oversight plans.
Responsible for the study budget and management of timelines.
Accountable for project-related efforts to deliver studies or programs, ensuring they are completed on time, within budget, and in compliance with SOPs, regulations, and ICH/GCP guidelines.
Education and Experience:
BA/BS degree in Health or Life Sciences required; MA/MS preferred.
Oncology therapeutic experience is strongly preferred, all stages with high complexity.
Minimum of 12+ years of clinical operations experience in a pharmaceutical, biotech, or CRO setting.
Solid understanding of the drug development process.
Competencies:
Adaptability:
Responds resourcefully, flexibly, and positively when faced with new challenges, transitions, and demands.
Collaboration:
Embodies and promotes collaboration and works effectively with others across the organization to achieve goals.
Execution:
Drives execution of strategic and operating plans while maintaining operational effectiveness.
Relationship Building:
Establishes and maintains strong relationships internally and externally.
Location:
Cambridge, MA (We are located in Lower Cambridge, called Cambridgeport)
When You Join Marengo, You Will Have:
Free parking, Cambridge location reachable by public transportation (Red Line).
Customized and competitive health coverage, including medical offered through BCBS (HMO/PPO), dental, and vision.
Flexible Spending Accounts for medical and dependent care expenses.
Eligible from the first day for 401K, no matching.
A robust package of Marengo-paid insurance coverage, including life insurance, short-term and long-term disability.
20 days of vacation and one personal day per year, in addition to 15 company holidays.
TO ALL AGENCIES:
Please, no phone calls or emails to any employee of Marengo about our openings. All resumes submitted by search firms/employment agencies to any employee at Marengo via email, the internet or in any form and/or method will be deemed the sole property of Marengo unless such search firms/employment agencies were engaged by Marengo for this position and a valid agreement with Marengo is in place. In the event a candidate who was submitted outside of the Marengo agency engagement process is hired, no fee or payment of any kind will be paid.
Marengo Therapeutics, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.
#J-18808-Ljbffr