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.
• Participate in and support continuous improvement of the contracts lifecycle management system.
• Manage the use of outside counsel taking into account cost, speed of review, and technical expertise.
• Other duties as assigned.

QUALIFICATIONS: 

Education: 

• JD degree or equivalent from an accredited law school required.
• BSc in molecular biology, genetics, biochemistry, or other biological field related to the biopharma industry is beneficial but not required.
• Admission to, and in good standing with, at least one U.S. state bar (CA preferred but not required).

Experience: 

• 8+ years practice as an attorney
  • 5+ years of in-house experience in the life sciences industry 
  • In-house experience at a publicly traded biotechnology, pharmaceutical, or biopharmaceutical company strongly preferred.
  • Large law firm experience supporting life sciences companies strongly preferred.
• Experience in counseling life sciences clinical and manufacturing teams with respect to day-to-day transactions and risk mitigation strategies.
• Proven experience reviewing and negotiating a wide-range of contracts described herein under tight timelines and with autonomous decision making.
• Proficient knowledge of current laws, regulations and industry standards, such as FDA regulations, ICH Guidelines, GxPs, FDCA, FCPA, FCA, AKS, HIPAA, and data privacy laws.
• Prior experience supporting global clinical trials, including registrational trials, intellectual property and technology related transactions is beneficial to the role.
• Experience handling commercial contract disputes and dispute resolution.
• Excellent analytical skills; creative, pragmatic problem-solving abilities in a transactional context; and efficient, precise drafting of customized agreements.
• Experience working with Finance teams and auditors, managing contracts processes and policies, and using contracts lifecycle management tools.

Other Qualifications/Skills: 

• Service-oriented focus with ability to work as part of cross-functional teams and drive results.
• Highest integrity, excellent judgment, and the ability to proactively recognize and effectively communicate legal issues to the Executive Director, Corporate Counsel and other members of company management.
• Innate leadership qualities to identify gaps and a step-up mentality to drive solutions.
• Ability to manage a full docket of responsibilities in a dynamic, fast-paced environment with aggressive timelines.

Travel: 5%

Physical Requirements and Working Conditions:

• Physical Requirements - Sedentary work: Exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.
• Working Conditions - The worker is not substantially exposed to adverse environmental conditions (as in typical office or administrative work).

Base salary compensation range: $242,000 - 282,000

Please note, the base salary compensation range and actual salary offered to the final candidate depends on various factors: candidate’s geographical location, relevant work experience, skills, and years of experience.