Job Description

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.

Role: Senior Director, Regulatory Affairs and Strategy

Purpose of the role:

Reporting to the Chief Development Officer, this team member will play a key strategic and management role in Marengo's regulatory organization. Senior Director of Regulatory Affairs and Strategy will develop and implement comprehensive regulatory strategies and oversee daily regulatory affairs activities, including the areas of clinical research, CMC, regulatory operations, nonclinical study requirements, and regulatory compliance to support the successful development, approval, and marketing of Marengo products. The ideal candidate for this role is an experienced, natural self-starter with strong organizational skills who thrives in a busy, fast-paced environment and can communicate effectively with executive leaders and key leaders of our external partners and customers.

Who are we looking for?

· You are an energetic and passionate regulatory professional 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 result orientation

· You consider yourself a SME in all the corporate REGULATORY AFFAIRS/REGULATORY STRATEGY in a clinical-stage organization

· 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 individual who enjoys working in close collaboration with leaders in the research, development, 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?

· Reporting to a Regulatory Guru, who has an extensive track of accomplishments

· Membership within a growing, CARING, and collegial organization

· Being part of a passionate, involved, and cutting-edge Development Team

· Exposure to pioneering science and the discovery of drugs to help treat patients with cancer

IF YOU ARE INTERESTED IN APPLYING, PLEASE READ ENTIRE POSTING

Responsibilities:

· Work closely with Marengo's Development leadership team to develop and implement regulatory strategies and objectives that result in the successful entry of Marengo's assets to the clinic, their development, marketing approvals, and post-approval commercialization.

· Provide regulatory expertise for product development, including the areas of clinical research, CMC, regulatory operations, nonclinical study requirements, and regulatory compliance.

· Serve as primary contact with FDA and other regulatory agencies to build a strong link between Marengo and these agencies to deliver our regulatory objectives by fostering strong rapport and acting as a credible, reputable, and effective advocate for Marengo.

· Provide Marengo's cross-functional program teams with critical assessment and input on regulatory strategies, risk planning and mitigations, critical issue management, and advice on regulatory interactions.

· Keep peers and superiors apprised of expected changes to the regulatory landscape affecting existing and future Marengo products and provide strategic and tactical direction to drive cross-discipline consistency in regulatory approach and planning.

· Strategize and manage the preparation and timely submission of regulatory documentation to support global investigational and marketing application packages.

· Represent Marengo in meetings with regulatory agencies/authorities; lead and oversee the preparation of meeting documents (e.g., requests, meeting packages); and strategize and prepare for meetings, virtual meetings, and other communications (e.g., Marengo's responses to information requests) with FDA and other regulatory agencies/authorities.

· Provide leadership on regulatory interactions and negotiation with global regulatory agencies/authorities to resolve key regulatory issues critical to the successful development of Marengo's portfolio.

· Maintain the expertise with the most updated knowledge on regulations and regulatory guidance documents from global regulatory agencies/authorities such as FDA, EMA, and ICH; make high-quality regulatory recommendations to Marengo's senior leadership and cross-functional teams; and ensure adherence to these regulatory guidance and regulations as well as Marengo's internal procedures.

· Manage external regulatory vendors/consultants as needed.

Education and Experience:

• Bachelor's degree in life sciences discipline (Biology, Chemistry, Engineering), MS/PhD/MD/PharmD preferred.
• More than 10 - 15 years of biotechnology or pharmaceutical industry experience, preferably at least 5 years of immuno-oncology experience.
• In-depth and comprehensive knowledge and understanding of drugs/biologics development process, regulatory requirements, regulations, and regulatory guidance.
• Extensive regulatory experience with INDs/CTAs, NDAs/BLAs/MAAs, and product lifecycle management.
• Rich and demonstrated skills and experience in interactions with regulatory authorities.
• Track record of significant regulatory accomplishments, such as IND submissions that have progressed to final approval.
• Excellent writing, interpersonal communications, organizational, and presentation skills. Established leadership and management skills with cross-functional teams in a matrixed organizational structure. Demonstrated experience with budgeting and planning.
• 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 13 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.