Director, Regulatory GCTI

About Us:

As a not-for-profit organization, Mass General Brigham is committed to supporting patient care, research, teaching, and service to the community by leading innovation across our system. Founded by Brigham and Women’s Hospital and Massachusetts General Hospital, Mass General Brigham supports a complete continuum of care including community and specialty hospitals, a managed care organization, a physician network, community health centers, home care and other health-related entities. Several of our hospitals are teaching affiliates of Harvard Medical School, and our system is a national leader in biomedical research.

We’re focused on a people-first culture for our system’s patients and our professional family. That’s why we provide our employees with more ways to achieve their potential. Mass General Brigham is committed to aligning our employees’ personal aspirations with projects that match their capabilities and creating a culture that empowers our managers to become trusted mentors. We support each member of our team to own their personal development—and we recognize success at every step.

Our employees use the Mass General Brigham values to govern decisions, actions and behaviors. These values guide how we get our work done: Patients, Affordability, Accountability & Service Commitment, Decisiveness, Innovation & Thoughtful Risk; and how we treat each other: Diversity & Inclusion, Integrity & Respect, Learning, Continuous Improvement & Personal Growth, Teamwork & Collaboration.

GENERAL SUMMARY / OVERVIEW:

The Gene and Cell Therapy Institute (GCTI) is a newly created system-wide Institute under Mass General Brigham. The Institute will foster a world-class gene and cell therapy program that will leverage ongoing, groundbreaking scientific research efforts across the MGB system.

The mission of GCTI is to bring together the community of MGB investigators which can utilize gene and cell therapy platforms to achieve their scientific and clinical goals and improve the health of patients. The Institute will differentiate itself by harnessing the exceptional strengths of clinician scientists, the large and unique patient population, and major discoveries throughout the hospital system to propel MGB as the leader in Gene & Cell therapies.

Reporting to the director of GCTI, regulatory strategy, position will lead the regulatory strategy team, formulate pre-clinical and clinical regulatory strategies, and engage with regulatory authorities. This position may also serve as the regulatory lead for product programs and work as the Global Regulatory Lead closely with a cross-functional Global Program Team to ensure regulatory strategy alignment and make regulatory submissions in high quality and on time.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

Lead the Regulatory Strategy team and provide pre-clinical and clinical regulatory strategies for gene therapy development programs in multiple therapeutic areas

Provide regulatory leadership in support of product portfolio strategy and business development initiatives

Support Regulatory Affairs Head to build and operate a high performing Regulatory Affairs organization

Serve as global regulatory lead for all regulatory responsibilities of assigned programs including the development and execution of regulatory strategies

Lead the preparations and submissions of regulatory dossiers in support of agency meetings (e.g., briefing documents), INDs, and regulatory designations (e.g., RMAT)

Lead / Participate in regulatory agency interactions and meetings

Conduct regulatory due diligence for external product opportunities

Assess and ensure regulatory compliance of all regulatory activities with applicable regulations and guidelines. Prepare or update regulatory SOPs and regulatory quality procedures

Seek for science based innovative regulatory solutions to support business objectives

An excellent team player and collaborator in a fast-paced matrix organization

Excellent skills in communicating and negotiating with regulatory agencies, internal stakeholders, and external customers

Have a patient centric mindset and is ready to roll the sleeves to accomplish the objectives

Empower, mentor, and retain key talents members

Diversity Statement

As a not-for-profit organization, Mass General Brigham is committed to supporting patient care, research, teaching, and service to the community. We place great value on being a diverse, equitable and inclusive organization as we aim to reflect the diversity of the patients we serve. At Mass General Brigham, we believe in equal access to quality care, employment and advancement opportunities encompassing the full spectrum of human diversity: race, gender, sexual orientation, ability, religion, ethnicity, national origin and all the other forms of human presence and expression that make us better able to provide innovative and cutting-edge healthcare and research.

PhD/MD/MS degree

10+ years of regulatory experience

Experience leading a regulatory affairs team

A track record of regulatory accomplishments in biologics required and in AAV based gene therapy strongly preferred

Experience in preparing briefing documents and IND/CTA submissions and achieving approvals

Experience in leading regulatory agency interactions, in written or in person

Familiar with the regulations and regulatory guidelines pertinent to gene therapy product development strongly preferred

Ability to articulate orally or in writing and build a strong regulatory rationale

Excellent interpersonal, collaboration, written, verbal and visual communication skills with ability to influence cross-functionally at all levels within the organization

A strong sense of accountability, sound judgement, and attention to details

SKILLS/ABILITIES/COMPETENCIES:

A proven regulatory leader with self-motivation in a fast-paced environment with sound judgement and science based regulatory approach.

Excellent interpersonal communication and negotiation skills to manage complex organizational relationships with cross-functional stakeholders and interactions with regulatory agencies.

Have a mission driven mindset, an ability to set goals, formulate and execute regulatory strategies, and excellent analytical and problem-solving skills to successfully address challenging regulatory questions and effectively reduce complex issues to regulatory narratives that are easy to be understood by target audiences.

Mass General Brigham is an Equal Opportunity Employer. By embracing diverse skills, perspectives and ideas, we choose to lead. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.