Director, Corporate Counsel

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee the drafting, review, negotiation, and execution of clinical trial agreements, clinical site and investigator agreements, CRO/vendor services contracts, master services agreements, work orders, change orders, CDMO development, supply, manufacturing services agreements, quality agreements, material transfer agreements, and technology transfer agreements.

• Evaluate and provide guidance on informed consent forms, letters of authorization, letters of indemnification, and other documentation related to clinical trials.

• Offer strategic and legal advice to clinical trial teams and internal stakeholders.

• Counsel on contractual risk allocation, indemnification, liability limitations, intellectual property rights, data rights, confidentiality, and adherence to regulatory requirements.

• Review, sanction, and provide insights on external-facing materials and outreach initiatives.

• Assist in the development of Legal Department policies, procedures, templates, and playbooks.

• Contribute to the ongoing enhancement of the contracts lifecycle management system.

• Manage external legal counsel based on cost considerations, review efficiency, and technical expertise.

• Report directly to the Executive Director, Corporate Counsel.

• Execute other responsibilities as assigned.

• Travel requirements: 5%.

⛳️ Requirements

• Juris Doctor (JD) degree or equivalent from an accredited law school is mandatory.

• Must be admitted to, and in good standing with, at least one U.S. state bar (California preferred but not mandatory).

• A minimum of 8 years of legal practice as an attorney.

• At least 5 years of in-house experience within the life sciences sector.

• Proven experience advising life sciences clinical and manufacturing teams on daily transactions and strategies for risk mitigation.

• Demonstrated ability to review and negotiate a diverse array of contracts under tight deadlines with a high degree of autonomy.

• Strong understanding of FDA regulations, ICH Guidelines, GxPs, FDCA, FCPA, FCA, AKS, HIPAA, and data privacy laws.

• Experience in managing commercial contract disputes and facilitating dispute resolution.

• Familiarity with working alongside Finance teams and auditors, overseeing contract processes and policies, and utilizing contracts lifecycle management tools.

• A service-oriented mindset with the ability to collaborate within cross-functional teams and achieve results.

• Highest integrity, outstanding judgment, and proactive identification and communication of legal issues.

• Capacity to manage a full docket in a dynamic, fast-paced environment with demanding timelines.

• A Bachelor's degree in molecular biology, genetics, biochemistry, or a related biological field is advantageous but not essential.

• Experience in a publicly traded biotechnology, pharmaceutical, or biopharmaceutical company, large law firm life sciences experience, and global clinical trial/IP/technology transaction experience are highly preferred or beneficial.

🏝️ Benefits

• Comprehensive health insurance plans.

• 401(k) retirement plan with company matching.

• Generous paid time off and holiday schedule.

• Opportunities for professional development and continuing education.

• Supportive and inclusive workplace culture.