Biotech Senior Director, Assistant General Counsel

Valid8 Financial, Inc.; Philadelphia (Philadelphia County); Hybrid; USD 180,000 - 240,000; Full time

Benefits offered by this job

Competitive benefits

Stock option plans

Paid time off (PTO)

Job summary

Cabaletta Bio in Philadelphia, PA, seeks a Senior Director, Assistant General Counsel to partner with Clinical Operations, Medical Affairs, Research and Commercial in a hybrid work setting.

You will translate complex legal and regulatory requirements into practical business guidance, negotiate across the U.S., Canada, EU and UK, and help shape the company’s compliance program with a focus on risk-based counsel.

Qualifications

• Juris Doctor degree with 8+ years of general corporate legal experience in biotechnology and/or pharmaceutical industries.
• 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.

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.

Skills

Strategic thinking

Cross-functional collaboration

Regulatory compliance

Education

Juris Doctor degree

Job description

Cabaletta Bio in Philadelphia, PA, seeks a Senior Director, Assistant General Counsel to partner with Clinical Operations, Medical Affairs, Research and Commercial in a hybrid work setting.

You will translate complex legal and regulatory requirements into practical business guidance, negotiate across the U.S., Canada, EU and UK, and help shape the company’s compliance program with a focus on risk-based counsel.