Vice President, Head of Compliance, Legal

Entrada Therapeutics•Boston, MA

4h•$325,000 - $380,000•Remote

About The Position

Entrada is a clinical-stage biopharmaceutical company aiming to transform the lives of patients by establishing a new class of medicines that engage intracellular targets that have long been considered inaccessible. Our Endosomal Escape Vehicle (EEV™)-therapeutics are designed to enable the efficient intracellular delivery of a wide range of therapeutics into a variety of organs and tissues, resulting in an improved therapeutic index. Through this proprietary, versatile and modular approach, Entrada is advancing a robust development portfolio of RNA- and protein-based programs for the potential treatment of neuromuscular and ocular diseases, among others. Our lead oligonucleotide programs are in development for the potential treatment of people living with Duchenne who are exon 44, 45, 50 and 51 skipping amenable. Entrada has partnered to develop a clinical-stage program, VX-670, for myotonic dystrophy type 1. You are passionate about compliance and regulatory excellence, thrive in a fast-paced environment, and are adept at managing complex issues. You bring deep expertise in compliance, legal, and regulatory affairs within the biotechnology, pharmaceutical, or life sciences sector, and are committed to upholding the highest standards of integrity and professionalism. At Entrada, you will join a team that values humanity, tenacity, creativity, collaboration, and curiosity. As Vice President of Compliance, you will serve as a senior leader and strategic advisor, responsible for designing, implementing, and overseeing a comprehensive compliance program. Reporting directly to the General Counsel, you will ensure Entrada’s adherence to all applicable laws, regulations, and ethical standards across research, development, manufacturing, distribution, and commercialization. You will champion a culture of integrity, transparency, and ethical behavior, and provide guidance to executive management and staff at all levels.

Requirements

Juris Doctor (JD) degree required; advanced degrees (e.g., MBA, MS, Ph.D.) are a plus.
Minimum of 10 years’ experience in compliance, legal, or regulatory affairs within the biotechnology, pharmaceutical, or life sciences sector.
Thorough knowledge of relevant regulations, standards, and best practices (FDA, EMA, DEA, GxP, HIPAA, GDPR, etc.).
Demonstrated experience developing and managing corporate compliance programs, preferably within a legal framework.
Proven ability to lead, communicate, and build strong interpersonal relationships.
Strong analytical and problem-solving abilities; adept at managing complex issues and making sound decisions.
Ability to collaborate effectively with cross-functional teams and drive organizational change.
High degree of integrity, professionalism, and commitment to ethical conduct.

Nice To Haves

advanced degrees (e.g., MBA, MS, Ph.D.) are a plus.
Experience launching a first product preferred.
Certification in compliance or regulatory affairs (e.g., CCEP, RAC) is a plus.
Experience with international regulations and multi-jurisdictional compliance programs.
Familiarity with biotechnology and pharmaceutical research processes, clinical trials, and product development lifecycle.
Advanced proficiency with compliance management software and reporting tools.

Responsibilities

Lead the design, implementation, and management of a robust compliance program, ensuring alignment with regulatory requirements, company policies, and industry best practices,
In close collaboration with other members of the legal team, regulatory affairs, medical affairs, and quality, create and oversee the implementation of a fit for purpose & fit for stage compliance strategy appropriate for a precommercial organization.
Monitor and interpret changes in relevant laws, regulations, and guidelines (e.g., FDA, EMA, OSHA, HIPAA, GDPR, DEA), providing timely legal and regulatory insight and guidance to the organization.
Establish and maintain policies and procedures to ensure compliance with standards governing clinical trials, pharmacovigilance, data protection, product safety, communications, and commercialization.
Conduct regular compliance risk assessments and audits; report findings and recommend corrective actions to the Legal department and senior management.
Lead internal investigations of potential compliance violations and manage responses to regulatory inquiries or inspections, in collaboration with legal counsel.
Develop and deliver compliance training and education programs for employees at all levels, integrating legal and regulatory perspectives.
Serve as the primary point of contact for regulatory bodies, external auditors, and legal counsel on compliance matters.
Collaborate with Medical Affairs, Clinical Development, Commercial Operations, R&D, Regulatory Affairs, Quality Assurance, Supply Chain, and Human Resources to ensure coordinated compliance efforts.
Prepare and present regular compliance reports.
Foster and promote a culture of ethical conduct, integrity, and transparency throughout the organization.