Executive Director, Assistant General Counsel, R&D

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The Talent Acquisition / HR team manages the recruiting for all positions at Adverum. We only accept resumes from search agencies or recruiters if the Talent Acquisition / HR team has formally requested your help and have a signed agreement in place. Unsolicited resumes sent to Adverum will be considered property of Adverum. The company will not be responsible for any associated fees should Adverum hire from unsolicited resumes. We request that recruiters do not to contact or present candidates directly to our hiring managers or employees. Doing so may jeopardize the candidate’s eligibility to work on future positions. Recruiters interested in working with Adverum can submit their information to [email protected]. Should we have a tough-to-fill role, we will contact you directly if you specialize in the needed area.

We are seeking a highly skilled and experienced Executive Director, Assistant General Counsel, R&D with a strong background in biotechnology. This individual will take ownership of legal issues in support of our Research & Development (R&D), Medical Affairs, Quality Affairs, and Technical Operations/CMC/Quality activities, including providing legal partnership, advice, support, and guidance on a variety of enterprise-critical issues in an evolving legal and regulatory environment as we work to bring new, innovative products to patients. The ideal candidate will leverage extensive in-house experience in clinical trials, manufacturing, and regulatory compliance to guide on high-impact legal and business matters, and solve emerging issues with a strategic and creative business-oriented approach, and provide expert counsel on decisions impacting the company’s strategic imperatives. Executive Director, Assistant General Counsel, and R&D will work in close partnership with business clients to achieve the company’s objectives while protecting the company’s interests, including ensuring compliance with all relevant laws and regulations. This role requires a deep understanding of the biotech industry, molecule development, clinical trial operations, drug manufacturing, and medical affairs arenas, excellent problem-solving skills, and the ability to work collaboratively with cross-functional teams.

To be successful in this role, you must be a strong collaborator, a flexible thinker, business-oriented, 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:

• Develop and provide strategic counsel to leaders at all levels of the company within the R&D, Medical Affairs and Technical Operations/CMC/Quality organizations on legal and regulatory issues that impact product development, scientific communications and product manufacturing. Matters handled have significant impact to Adverum overall.
• Proactively identifies highly complex legal issues related to matters within the scope of responsibilities, develops creative and alternative solutions, and collaborates on implementation and resolution while protecting the interests of Adverum.
• Adopts a business oriented and creative approach to problem solving.
• Identifies unmet needs and future legal issues and proactively proposes strategies to optimize outcomes and results for the company.
• Capable of leading projects, including cross-functional teams, from inception through to implementation.
• Able and willing to provide hands on support, including drafting, reviewing and negotiations of contracts and other legal documents.
• Partner across the business to achieve compliance with all applicable laws and regulations, including intellectual property, data privacy, GxP, and other regulatory requirements.
• Develop deep knowledge of the Company’s business and provide thoughtful, creative and business-minded legal advice and recommendations to achieve business and strategic objectives while mitigating legal risks.
• Act as a proactive business partner to all levels of the organization and build trusted advisor relationships in addition to influencing and collaborating effectively across all levels of the organization.
•  Conduct legal research and stay up to date with changes in laws and regulations that may impact the company's research and development activities.
• Assist in the negotiation and management of partnerships, collaborations, and licensing agreements.
• Provide training and guidance to internal teams on legal matters related to research and development, manufacturing and quality.
• Mentor legal staff and collaborate with external counsel to achieve organizational goals.
• Perform additional duties as assigned.

About you:

• Juris Doctor (JD) degree from an accredited law school and currently admitted to the bar in at least one U.S. state;
• Minimum of 15+ years of relevant experience either practicing as a member of a nationally recognized law firm in a life sciences practice or practicing in-house at a pharmaceutical company or a combination of the two;
• Strong knowledge and understanding of pharmaceutical laws and regulations to help business clients assess issues in a highly regulated landscape;
• Ability to adapt to a changing environment while handling multiple priorities;
• Sound judgment and ability to effectively and efficiently support decision making.
• Familiarity with clinical trial agreements, material transfer agreements, and other R&D-related contracts;
• Knowledge of FDA regulations and guidelines related to biotech products;
• Excellent analytical, problem-solving, and communication skills;
• Ability to work independently and as part of a team in a fast-paced environment;
• Strong attention to detail and organizational skills;
• Strong personal integrity and a global mindset;
• Ability to manage heavy workload and aggressive timelines in a timely manner, prioritize and work under pressure;
• Experience with international regulatory processes for pharmaceutical products and laws and regulations governing clinical trials is a plus;
• Experience assisting with legal agreements surrounding assay development is a plus;
• Experience with advising and guiding manufacturing/CMS/tech ops with manufacturing development and build, including equipment builds/purchases and process validation is a plus;
• Excellent communication skills. Comfortable presenting complicated information accurately and concisely to senior leaders.
• Possess the ability and willingness to advance new ideas and recognize when decisions may have a broad impact on the global organization;
• Ability to influence without authority, as well as manage multiple projects, with limited oversight, in a fast-paced, evolving environment;
• Consistently take action and drive issues to closure and hold self-accountable for achieving results;
• Strong collaborator and adept at understanding the motivation and needs of others and effectively communicating with a diverse audience in a manner that generates confidence and support for proposals/recommendations.

Adverum is a clinical-stage gene therapy company targeting unmet medical needs in ophthalmology and rare diseases. Adverum develops gene therapy product candidates designed to provide durable efficacy by inducing sustained expression of a therapeutic protein. Adverum’s core capabilities include clinical development, novel vector discovery and in-house manufacturing expertise, specifically in scalable process development, assay development, and current Good Manufacturing Practices quality control.

At Adverum, Inclusion and Diversity are at our core. We believe in the power of being your authentic self. We strive to create the space which allows for everyone in our Adverum Community to not only feel safe but encouraged to speak, learn from each other, grow in their professions and be the very best versions of themselves no matter what their age, ethnic background, gender, origin, religion or sexual orientation