Director, Corporate Counsel
Attention recruitment agencies: All agency inquiries are vetted through 4DMT ’s internal Talent Acquisition team. No unsolicited resumes will be accepted. The 4DMT Talent Acquisition team must expressly engage agencies on any requisition. Agencies contacting hiring managers directly will not be tolerated, and doing so may impact your ability to work with 4DMT in the future.
4DMT is a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to transform treatment paradigms and provide unprecedented benefits to patients. The Company’s lead product candidate 4D-150 is designed to be a backbone therapy forming the foundation of treatment of blinding retinal vascular diseases by providing multi-year sustained delivery of anti-VEGF (aflibercept and anti-VEGF-C) with a single, safe, intravitreal injection, which substantially reduces the treatment burden associated with current bolus injections. The Company’s lead indication for 4D-150 is wet age-related macular degeneration, which is currently in Phase 3 development, and second indication is diabetic macular edema. The Company’s second product candidate is 4D-710, which is the first known genetic medicine to demonstrate successful delivery and expression of the CFTR transgene in the lungs of people with cystic fibrosis after aerosol delivery
GENERAL SUMMARY
4DMT is seeking an experienced transactional attorney with a broad range of in-house experience to support and counsel its internal stakeholders ranging from pre-clinical through commercial readiness. The role will serve as a key advisor to Clinical Science, Clinical Operations, CMC & Technical Operations, Supply Chain, Medical Affairs and other departments as needed, counseling on transactional matters, risk allocation, and compliance considerations that arise throughout the drug development and manufacturing lifecycle.
The role will have an emphasis on drafting, negotiating, and managing contracts with industry partners, clinical trial sites, CROs, company vendors, HCPs and other entities and is expected to serve as a highly collaborative, attentive, and trusted advisor for its internal stakeholders. Substantive experience drafting and negotiating agreements required for clinical trial execution and clinical product manufacturing is essential. In-depth knowledge of the drug development and clinical trial processes, regulatory and compliance requirements, strategic partnerships, and intellectual property is strongly preferred.
In this role, the Director, Corporate Counsel will report directly to the Executive Director, Corporate Counsel.
MAJOR DUTIES & RESPONSIBILITIES:
- Lead the drafting, review, negotiation, and execution of a broad spectrum of agreements including, without limitation, clinical trial agreements, clinical site and investigator agreements, CRO and other vendor services agreements, master services agreements, work orders, change orders, CDMO development agreements, supply agreements, manufacturing services agreements, quality agreements, material transfer agreements, and technology transfer arrangements.
- Review and advise on clinical trial related documents, such as informed consent forms, letters of authorization, and letters of indemnification, and provide other strategic and legal counsel to clinical trial teams.
- Advise stakeholders on contractual risk allocation, indemnification, limitations of liability, ownership of intellectual property, data rights, confidentiality, and regulatory compliance, providing practical, risk-based legal counsel to support the timely progression of clinical programs and business initiatives.
- Review, approve, and advise on external facing materials & outreach initiatives, providing counsel on potential legal issues and appropriate risk mitigation strategies related thereto.
- Assist with development of Legal Department policies, procedures, templates, and playbooks relating to Legal Department activities.
-