Quick Info
Job Type
Full TimeSpecialty Skills
corporate lawlicensing agreementscollaboration agreementsCRO agreementsCDMO agreementsclinical trial agreementssupply agreementsconsulting agreementsM&Ajoint venturescorporate governancesecurities lawfundraisingdisclosureGCPGLPFDAEMAICHHIPAAGDPRIP lawbiotechnology law
About the Role
We are looking for a highly motivated and pragmatic Senior Director, Corporate Counsel, to join our team. In this critical leadership role, you will provide strategic legal guidance on complex corporate matters, ensure compliance with regulatory requirements, and partner with senior executives to drive business objectives.
This is a unique opportunity to contribute to advancing a novel cell therapy that has the potential to become a meaningful option for patients with advanced or metastatic melanoma and other solid tumors. Supported by blue chip investors, field-leading advisors, best-in-class partners, and an experienced team, you'll be part of a dynamic, innovative, passionate, and collaborative team.
You Will…
* Draft, review, and negotiate a wide range of agreements, including licensing, collaboration, CRO, CDMO, clinical trial, supply, and consulting agreements.
* Support business development and strategic transactions such as M&A, joint ventures, and research collaborations.
* Advise on corporate governance, subsidiary management, and Board matters.
* Partner with Finance and Corporate Development teams on securities, fundraising, and disclosure issues as needed.
* Provide legal and strategic guidance on clinical trial operations, including protocol development, site and investigator contracting, informed consent, and patient data protection.
* Collaborate closely with Clinical Operations, Regulatory Affairs, and R&D teams to ensure compliance with GCP, GLP, and other regulatory frameworks (FDA, EMA, ICH).
* Advise on preclinical and translational research agreements, material transfer agreements (MTAs), and sponsored research arrangements with academic and industry partners.
* Support ethical review and IRB/EC processes, ensuring adherence to applicable laws and regulations governing human subject research.
* Develop and maintain policies and procedures for compliance with healthcare, anti-bribery, data privacy (HIPAA, GDPR), and industry-specific regulations.
* Provide training to internal stakeholders on legal, compliance, and contracting best practices.
* Partner with internal audit and compliance functions to monitor risk and implement mitigation strategies.
* Collaborate with IP counsel on patent strategy, research collaborations, and IP ownership provisions in contracts.
* Support data sharing, data use, and publication agreements consistent with scientific integrity and company IP strategy.
* Serve as a trusted advisor to senior management and business leaders on strategic initiatives and legal risk.
* Participate in cross-functional governance committees (e.g., Clinical Development, Research, Compliance).
* Develop best practices for legal operations and contract management systems.
* Manage relationships with outside counsel and external partners to ensure high-quality, cost-effective legal services.
* Represent the company in industry associations and forums relevant to biotechnology law, research compliance, and clinical innovation.
You Bring…
_Core Qualifications_
* Juris Doctor (JD) with 10+ years of experience, 3-5+ in-house at a clinical stage publicly traded company is preferred.
* Several years of experience at a Corporate Law Firm.
* Experience with strategic transactions, including financing, partnerships/collaborations, or mergers & acquisitions.