Paralegal, R&D

Adverum Biotechnologies, Inc. is a mission-driven clinical-stage company that aims to establish gene therapy as a new standard of care for highly prevalent ocular diseases with the aspiration of developing functional cures to restore vision and prevent blindness. Leveraging the research capabilities of its proprietary intravitreal (IVT) platform, Adverum is developing durable, single-administration therapies designed to be delivered in physicians’ offices to eliminate the need for frequent ocular injections to treat these diseases. By overcoming the challenges associated with current treatment paradigms for these debilitating ocular diseases, Adverum aspires to transform the standard of care, preserve vision, and create a profound societal impact around the globe.

Note to Recruiters and Agencies

All recruiter and agency inquiries must go through Adverum’s internal Talent Acquisition team. Unsolicited resumes sent to Adverum will be considered Adverum's property. Adverum’s Talent Acquisition team must expressly engage agencies for any requisition. Direct contact with hiring managers by agencies will not be tolerated and may affect your ability to work with Adverum in the future.

Adverum seeks a highly skilled and motivated R&D Paralegal to join our legal team. The ideal candidate will have a strong background negotiating agreements related to pre-clinical and clinical research (international experience a plus) as a legal assistant, paralegal, or in a contracts role in a legal or procurement-type department supporting clients in the pharmaceutical/biotech industry. The Paralegal, R&D will possess excellent organizational and communication skills and provide legal support and assistance for various R&D and Quality Affairs-related activities, including contract development, negotiation, and clinical study start-up. You will interact with leadership and other stakeholders from multiple cross-functional teams and have responsibility on a broad range of R&D and Quality-related activities.

To be successful in this role, you must be a strong collaborator, a flexible thinker, someone who appreciates the strength of a team, the power of a positive mindset, and the ability and willingness to value and respect differences.

What you'll do:

• Review, interpret, negotiate, and draft a high volume of various clinical study-related and quality study-related agreements such as clinical trial agreements, investigator-initiated study agreements, facility use agreements, pharmacovigilance agreements, quality agreements, material transfer agreements, technology transfers, HCP consulting/advisory agreements, and licensing and collaboration agreements with academic institutions and strategic partners;
• Support review and negotiations of Informed Consent Forms in connection with U.S. and global clinical trials agreement, including the ability to effectively liaison with internal and external privacy law experts on relevant legal requirements;
• Drive increased efficiency, coordination, and effectiveness of R&D contracts processes and support to meet the needs of the business and other key stakeholders;
• Utilize strong business acumen and legal expertise to proactively identify, analyze, and navigate potential legal and compliance issues and risks associated with contract terms and other activities within areas of responsibility, and work with attorneys to formulate and communicate compliant and practical solutions that meet business objectives;
• Communicate with business partners regarding the risks presented by contract terms and possible strategies to mitigate such risks;
• Work within Adverum’s contracts management system;
• Assist with fact-gathering to support legal advice;
• Develop and deliver presentations and training on R&D legal and contracts-related topics as needed;
• Tracking and reporting on the status of recent developments in certain areas of the law;
• Establish strong business partnership relationships characterized by a high level of collaboration, trust, and mutual respect;
• Support development and implementation of contract playbooks (including for non-disclosure agreements, clinical trial agreements, and other high-volume agreement types), templates, and processes;
• Review of study start-up documents (including patient recruitment materials) and various client presentations; and
• Perform additional duties as assigned based on work needs

About you:

• Paralegal certification is a plus.
• Minimum of five years of previous paralegal experience.
• Experience in the life sciences/biotech/pharma sector is a must.
• Experience negotiating agreements related to pre-clinical and clinical research (international experience a plus), supporting clients in the pharmaceutical/biotech industry;
• Self-motivated, a good listener, collaborative, responsible, flexible, and have excellent attention to detail;
• Handle confidential and proprietary information using discretion and sound judgment;
• Strong written and oral communication skills;
• Strong organization skills and demonstrated ability to manage multiple projects as well as working and meeting deadlines in a fast-paced environment with a high degree of accuracy and efficiency is critical in this role;
• Excellent customer service skills, with an ability and willingness to develop and nurture strong relationships with colleagues and key stakeholders to advance project goals and objectives;
• Applies professional/technical expertise along with company policies and procedures to resolve a variety of issues within the scope of responsibility