Job Description - Senior Director, Assistant General Counsel - Hybrid, Philadelphia, PAPhiladelphia, PAReporting 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. The Senior Director, Assistant General Counsel brings a strong background in life sciences or biotechnology, with a demonstrated ability to navigate complex legal issues in a fast-paced and collaborative environment.
Responsibilities: - 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.
Qualifications: - 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.
Preferred: -
- Experience in industry or in a startup or growth-stage company setting.
- Experience with promotional review committees.
- Experience advising on employment-related matters and supporting HR functions.
Our name - Cabaletta - is derived from the operatic term that represents a rapid, repetitive, and technically challenging section of an operatic aria, designed to showcase the skills of the lead singer. Analogously, Cabaletta Bio strives to achieve rapid and repetitive product development, building on our indication prioritization and biologic platform that targets the driver of specific autoimmune diseases without the need for long-term immunosuppression.
For more information, please visit https://www.cabalettabio.com/join-our-crew
Our most important asset is our people, and we offer competitive benefits, PTO, and stock option plans.
#LI-HYBRID 
