Senior Director, Assistant General Counsel
Cabaletta Bio
August 20, 2026
Remote friendly (Philadelphia, PA)
United States
Corporate Functions
About the Position: Hybrid/Philadelphia, PA
Reporting to the General Counsel, the Senior Director, Assistant General Counsel will serve as a trusted legal advisor and strategic business partner to Clinical Operations, Medical Affairs, Research, Commercial and Manufacturing and other cross-functional stakeholders, enabling efficient decision-making while appropriately managing legal and compliance risk.
Responsibilities:
- Translate complex legal and regulatory requirements into practical, business-oriented advice.
- Proactively support Clinical Operations, Medical Affairs, Research, and Commercial.
- Draft, review, and negotiate clinical trial agreements and related informed consent forms/protocols; R&D agreements; manufacturing and supply agreements; consulting agreements; service agreements; and material transfer agreements for the U.S., Canada, EU, and UK.
- Provide legal support for certain pre-launch commercial activities, including promotional review committee review and compliance guidance (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 for participant/patient/employee data.
- Collaborate to ensure regulatory compliance (clinical trials, FDA regulations, GCP requirements, and healthcare compliance).
- Support policy development, ethical practices, and implementation of the compliance program.
Qualifications:
- J.D. with 8+ years general corporate legal experience in biotechnology and/or pharmaceutical industries (in-house, private practice, or both).
- 3+ years law firm practice preferred.
- Pragmatic, risk-based legal guidance; strategic thinker.
- Strong team orientation and relationship-building; integrity/ethics.
- Ability to manage multiple complex tasks.
- Solid knowledge of pharma industry legal issues, including clinical development/medical affairs/research collaborations/regulatory processes, anti-kickback, fraud and abuse, anti-bribery/anti-corruption, and antitrust.
Preferred:
- Experience in industry/startup or growth-stage company.
- Experience with promotional review committees.
- Employment-related matters and HR support experience.
Reporting to the General Counsel, the Senior Director, Assistant General Counsel will serve as a trusted legal advisor and strategic business partner to Clinical Operations, Medical Affairs, Research, Commercial and Manufacturing and other cross-functional stakeholders, enabling efficient decision-making while appropriately managing legal and compliance risk.
Responsibilities:
- Translate complex legal and regulatory requirements into practical, business-oriented advice.
- Proactively support Clinical Operations, Medical Affairs, Research, and Commercial.
- Draft, review, and negotiate clinical trial agreements and related informed consent forms/protocols; R&D agreements; manufacturing and supply agreements; consulting agreements; service agreements; and material transfer agreements for the U.S., Canada, EU, and UK.
- Provide legal support for certain pre-launch commercial activities, including promotional review committee review and compliance guidance (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 for participant/patient/employee data.
- Collaborate to ensure regulatory compliance (clinical trials, FDA regulations, GCP requirements, and healthcare compliance).
- Support policy development, ethical practices, and implementation of the compliance program.
Qualifications:
- J.D. with 8+ years general corporate legal experience in biotechnology and/or pharmaceutical industries (in-house, private practice, or both).
- 3+ years law firm practice preferred.
- Pragmatic, risk-based legal guidance; strategic thinker.
- Strong team orientation and relationship-building; integrity/ethics.
- Ability to manage multiple complex tasks.
- Solid knowledge of pharma industry legal issues, including clinical development/medical affairs/research collaborations/regulatory processes, anti-kickback, fraud and abuse, anti-bribery/anti-corruption, and antitrust.
Preferred:
- Experience in industry/startup or growth-stage company.
- Experience with promotional review committees.
- Employment-related matters and HR support experience.