Associate Director, Legal

Position Summary

Reporting directly to the Head of Corporate Legal Affairs, the Associate Director will enjoy a strategic, cross-functional and global role with responsibility over a broad range of legal and strategic matters and ability to help guide the growth and direction of the Company. We are a cohesive and collaborative legal team looking to expand our expertise and, importantly, onboard someone who is passionate about patient care, willing to jump in and grow both personally and professionally, and is collaborative and creative in their approach. This attorney will work on matters relating to regulatory requirements for investigational and approved products, regulatory submissions, clinical trials, drug safety management, labeling, as well as R&D and clinical compliance.  The successful candidate will have direct client responsibility in support of a broad range of company R&D and the company’s global privacy program.

Key Duties and Responsibilities

• Primary responsibility for support of the Company’s Translational Science, Clinical Development, Regulatory and Manufacturing functions.
• Draft and negotiate a range of contracts including, pre-clinical, non-clinical, supply, speaker, grant, vendor, consulting, ad board, clinical trial, manufacturing, research & development, academic research, non-disclosure and collaboration agreements.
• Support collaborations with academic and government institutions around the world (e.g., NIH, NCI), while working closely with the Company’s IP attorneys to protect the Company’s IP.
• Ensure compliance with all applicable laws, foreign and domestic, and regulations including those related to our products and privacy matters.
• Conduct legal review of external materials as part of a cross-functional committee. Review press releases, promotional materials and publications for appropriate IP and regulatory disclosures and potential legal risks.
• Ensure compliance with regulatory requirements governing the Company’s relationship with healthcare providers and scientific community members.
• Interpret company policies and develop risk mitigation strategies relating to conducting clinical trials providing funding for scientific research, data sharing, patient recruitment, anti-kickback rules, informed consent requirements and privacy protections.
• Negotiate agreements and provide counsel regarding contracting with health care professionals, institutions, study sites, foundations, and government entities.
• Work with IT on cyber security practices and policies.
• Assist with due diligence and support Head of Corporate Legal Affairs with various projects/tasks.
• Travel approximately 10% of the time, primarily to the company’s San Diego facility, which houses the Research and Development function.  International travel may be required occasionally.
• Other duties as assigned in support of the company’s global legal function.

Desired Education, Skills and Experience 

• JD degree required
• Admission to a US state bar, and eligibility for California In-House Counsel license are required
• 5+ years of legal experience in the life sciences industry, preferably with a combination of law firm and in-house experience.
• Experience with pre-clinical, non-clinical, Chemistry and Manufacturing Controls (CMC) and clinical trial agreements and working knowledge of GxP requirements.
• Ability to review and advise on clinical trial protocols, informed consents, QTAs, and other documents related to CMC and clinical trials.
• Ability to review and advise on biologic and combination product regulatory submissions in the US, EU, and Asia; experience with medical devices also a plus.
• Working knowledge of collaborations with academic and government institutes (e.g., universities, NIH, NCI) and ability to issue spot intellectual property protection concerns to work closely with IP company attorneys.
• Working knowledge of healthcare compliance (e.g., provider and scientific community member interactions, FCPA, Anti Kick-Back rules, Fair Market Value).
• Working knowledge of HIPAA obligations.
• Familiarity with in-house global privacy programs for a multi-national pharmaceutical or biotech company with a focus on Europe, Asia, and North American privacy requirements.
• Must be a strategic, creative and out-of-the box thinker willing to work in a fast paced, start up environment with a focus on collaboration and team.
• Demonstrated experience with effectively managing multiple projects/priorities.
• A legal thought partner to the business – with an ability to work effectively with, influence, and get consensus across functional units and at all levels in the organization as well with external parties.
• A “can do” open minded professional who wants to grow in their career and work proactively with both internal and external resources to drive results.
• Excellent interpersonal skills, a creative thinker and overall good human who can build and maintain positive work relationships and effectively interface across the organization.
• Ability to work effectively with, influence, and get consensus across functional units and at all levels in the organization as well with external parties.

The expected salary range for this position based in California is $154,000 - $200,000 annually. Actual pay will be determined based on experience, qualification, geographic location, and other job-related factors.