Senior Director, Assistant General Counsel

Cabaletta Bio

Senior Director, Assistant General Counsel at Cabaletta Bio advising on legal compliance and corporate governance. Collaborating across various departments to manage legal risks in clinical development.

Posted 7/30/2026full-timePhiladelphia • Pennsylvania • 🇺🇸 United StatesSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Expertise in translating complex legal and regulatory requirements into practical business guidance, with a strong focus on compliance in the pharmaceutical industry. Proven ability to draft and negotiate various agreements while collaborating with cross-functional teams to ensure regulatory adherence.

Highest-signal resume keywords

Juris Doctor Degree8+ Years Corporate Legal ExperienceClinical Trial AgreementsRegulatory CompliancePharmaceutical Industry Knowledge

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Drafting AgreementsNegotiating ContractsLegal GuidanceRisk ManagementCompliance Advisory

Soft Skills

Strategic ThinkingTeam OrientationRelationship BuildingIntegritySelf-Development

Industry Keywords

BiotechnologyPharmaceuticalsClinical DevelopmentFDA RegulationsGCP RequirementsGDPR ComplianceAnti-Kickback LawsFraud and AbuseAnti-BriberyAntitrust Laws

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Translate complex legal and regulatory requirements into practical, business-oriented advice for internal stakeholders.
Proactively support a broad range of functions within the Company, with a primary focus on Clinical Operations, Medical Affairs, Research, Commercial.
Draft, review, and negotiate a wide variety of agreements including: clinical trial agreements and related informed consent forms and protocols; research and development agreements; manufacturing and supply agreements; consulting agreements; service agreements; and material transfer agreements for activities in the U.S., Canada, EU and UK.
Provide legal support for certain commercial activities ahead of commercial launch, including serving as reviewer on promotional review committees and advising on compliance matters, including HCP engagements, speaker programs, advisory boards, grants, charitable contributions, sponsorships, consultant arrangements, and interactions with healthcare organizations.
Advise on U.S. privacy and EU / UK GDPR issues as they relate to clinical trial participant, patient and employee data.
Collaborate with cross-functional teams to ensure regulatory compliance across relevant aspects of the business, including clinical trials, FDA regulations, GCP requirements and healthcare compliance.
Support the development of Company policies and promote ethical practices; and support the implementation of the compliance program throughout the organization.

Requirements

What you’ll need

Juris Doctor degree with 8+ years of general corporate legal experience in biotechnology and/or pharmaceutical industries in either in-house, private practice or a combination of both.
3+ years in practice with an established law firm preferred.
Demonstrated ability to provide pragmatic, risk-based legal guidance in support of business objectives.
Strategic thinker who translates complex legal and regulatory requirements into practical business guidance.
Strong team orientation with a demonstrated ability to build strong relationships across various business functions and a passion for continuous self-development.
Ability to manage multiple complex tasks with a focus on critical priorities.
Outstanding integrity and ethical conduct.
Solid understanding of the legal issues affecting the pharmaceutical industry, with a particular focus on clinical development, medical affairs activities, research collaborations and regulatory processes for prescription drugs, anti-kickback, fraud and abuse, anti-bribery and anti-corruption and antitrust laws.
Experience in industry or in a startup or growth-stage company setting preferred.
Experience with promotional review committees preferred.
Experience advising on employment-related matters and supporting HR functions preferred.

Benefits

Comp & perks

Competitive benefits
PTO
Stock option plans