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

Qualifications

• 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.