Marengo Therapeutics, Inc., a clinical-stage biotech company, develops novel TCR-targeting antibodies that selectively modulate common and disease-specific T cell subsets of the germline TCR repertoire to provide lifelong protection against cancer and other diseases. With a passionate team of dedicated scientists experienced in immunology and oncology, Marengo's proprietary Selective T Cell Activation Repertoire (STAR) platform leverages an extensive biological understanding of T cell function and receptor signaling to create a world in which everyone's immune system can defeat cancer. To learn more, visit marengotx.com.
About STAR0602
STAR0602 is Marengo's lead program, the first selective T cell activator generated from Marengo's STAR platform; a library of antibodies targeting non-clonal variable (V)ß regions of the TCR fused to different co-stimulatory moieties. STAR0602 selectively targets a common Vb T cell subset present in all cancers and, by combining a novel non-clonal mode of TCR activation with a T cell co-stimulator in the same molecule, promotes expansion of a new population of clonally enriched, effector memory Vb T cells that turbo-charge immune system and promote a durable anti-tumor immune response. STAR0602 has undergone extensive preclinical testing, which demonstrates potent anti-tumor activity in both mouse and human ex vivo tumor models attributed to a distinct mechanism of action from existing cancer immunotherapies.
The Head of Biometrics is responsible for developing and overseeing the biometrics function for Marengo's rapidly expanding clinical portfolio of therapeutics. The successful candidate will play a key role in strategizing and executing the clinical development programs during the life cycle of Marengo's products. As a senior leader and subject matter expert, this individual will provide statistical expertise in keeping with the latest cutting-edge methodologies to inform decision-making across the portfolio and at the project level, ensuring the conduct of sufficient and rigorous statistical analyses, adequate and objective interpretation, reporting and publishing the study results. This role also involves overseeing the CROs in delivering proper, high-quality statistical activities for all studies. The successful candidate will have the ability to bring creative/innovative clinical designs to define and apply the most effective approach across Marengo's R&D pipeline while working closely with drug development teams (e.g., drug discovery, immunology, clinical development, clinical operations, regulatory, safety, and pharmacovigilance). This position will report to the Chief Development Officer.
Job Description:
· Ensure advanced and innovative statistical concepts are routinely applied across the design/experimental strategy, analysis, and interpretation phases of both preclinical and clinical studies to improve the quality and productivity of Marengo's pipeline
· Plan, organize, and execute biometrics activities associated with all regulatory submissions (pre-IND, IND, NDAs/BLAs, post-marketing submission), for example, statistical analysis plans, analysis specifications for clinical trial documents and reports, protocols, investigator brochures, as well as preparation of submission data packages compliant with regulatory standards; Review and analyze safety reporting, perform biomarker analyses and other aspects of clinical trial monitoring
· Represent Marengo as the senior statistical executive for Health Authorities (e.g., FDA, EMA, NMPA, etc.) and participate in all regulatory meetings for clinical programs and interactions with Health Authorities; Serve as Marengo's primary contact for addressing requests from and resolving biometrics-related issues raised by, Health Authorities, Institutional Review Boards, and local Institutional Ethics Committees
· Provide high-level updates and advice to senior management, including evaluation and interpretation of clinical trial study design and their potential impact on Marengo's programs and clinical/regulatory strategy
· Lead CRO and vendor interactions for biostatistics, statistical programming, and data management functions and ensure timely delivery of CRO expectations
· Maintain knowledge of regulations and regulatory guidance of Health Authorities, new programming and database technologies, and standards
· Use statistical expertise to influence both internal and external stakeholders with the aim to improve the quality of internal decision-making.
· Plan and document computer data file structure; Develop, program, manage, and maintain complex statistical databases; Perform or supervise data entry
· Use a variety of advanced statistical software, methods, and techniques to gather, analyze, and interpret research data; Advise and assist in the development of inferences and conclusions, as appropriate
· Monitor all external data management functions and monitor efficient work of all internal and external bio-analysts and programmers
· Conduct QC activities when needed
Requirements/Qualifications:
· Ph.D. or master's degree in Statistics, Biostatistics, or related discipline
· At least 10-15 years of experience in the pharmaceutical/biotechnology industry in oncology clinical development; immuno-oncology (I/O) experience is highly preferable
· Comprehensive expertise and demonstrated experience in drug development of all phases and approvals, including knowledge of interfaces and interdependencies of clinical development with other functions
· Experience handling data management and statistical programming components, including SAS, CDISC (e.g., SDTM and ADaM), EDC systems, and R (for simulations) or other statistical software
· Knowledge of applicable regulatory rules and guidelines, e.g., ICH, GCP, HIPAA
· Knowledge and understanding of the principles, concepts, methods, and standards of statistical research
· Ability to consult with scientific investigators, interpret research requirements and determine statistical analysis strategies
· Demonstrated experience in working with CROs
· Knowledge of scientific reporting and manuscript preparation requirements and standards
· Strong analytical communication, critical thinking, and problem-solving skills
· Excellent time management skills and ability to prioritize projects
· Strong focus and quality and timely delivery of work
The candidate should be capable of operating with a high level of autonomy but get into the operational details as required. This is a strategic but hands-on role.
Competencies:
Adaptability: Responds resourcefully, flexibly, and positively when faced with new challenges, transitions, and demands. Willingly and effectively deals with the stress and complexities of various situations. Moves forward productively and optimistically under conditions of change and uncertainty.
Collaboration: Embodies and promotes collaboration and works effectively with others across the organization to achieve goals. Demonstrates proficient cross-company communication, cultural sensitivity, and partnership in interactions with others. Involves others in decisions and plans and credits them for their contributions and accomplishments.
Execution: Drives execution of strategic and operating plans while maintaining operational effectiveness. Conveys a strong sense of urgency around continuous improvement, achieving high-quality results, and accelerating business performance. Addresses problems directly and drives changes necessary to achieve business objectives.
Relationship Building: Establishes and maintains strong relationships internally and externally. Respects and relates well to management, colleagues, peers, and direct reports. Champions a culture of respect, diversity, and inclusion that values and respects individuals. Earns the respect of others through principled leadership, sound business ethics, and authenticity.
Location: Cambridge, MA (We are located in Lower Cambridge)
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 (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 16 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.
Apply Here: https://www.click2apply.net/Vnnqo1fkKODwEf1wjiOpQD
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