General Counsel
Audentes Therapeutics (NASDAQ: BOLD) is a biotechnology company committed to the development and commercialization of innovative new gene therapy...
Audentes Therapeutics (NASDAQ: BOLD) is a biotechnology company committed to the development and commercialization of innovative new gene therapy treatments for people with serious rare diseases. We are a focused, experienced and passionate team driven by the goal of improving the lives of patients. We currently have four programs in development for the treatment of X-Linked Myotubular Myopathy (XLMTM), Crigler-Najjar Syndrome, CASQ2-related Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT) and Pompe disease. The Company has internal drug discovery, development, regulatory and manufacturing capabilities, and expects to commercialize its first products within the next 2-3 years.
Audentes takes pride in strong, global relationships with the patient, research, and medical communities, and we take equal pride in carefully selecting our colleagues. If you believe you match what we're looking for, we'd love to hear from you. Our compensation philosophy embodies what you'd expect from an innovative life sciences employer competing to recruit and retain the best talent in the industry.
The Role
Reporting to the Chief Executive Officer, the General Counsel will provide global legal counsel on applicable regulations, statutes, intellectual property and corporate governance issues arising from a US-based public gene-therapy focused biotechnology corporation with international subsidiaries. The General Counsel will also provide leadership and legal perspectives on the Company's commercial operations, patient support services and medical affairs initiatives, government price reporting, and serve as the Company's Chief Compliance Officer. The job is based in our San Francisco headquarters and requires domestic and international travel.
Specific responsibilities include but are not limited to:
Develop and implement an overall corporate risk/compliance program.
Manage all legal matters for the Company and its affiliates.
Oversee matters related to compliance with US and ex-US clinical, quality, commercialization and securities laws and related regulations.
Oversee the negotiation, execution and ongoing compliance with service provider, academic collaborator, and technology/IP licensing contracts in support of the company's business objectives.
Manage the intellectual property portfolio with a demonstrated strategic approach by anticipating future business, competitive and legal risks.
Manage all outside corporate counsel.
Manage any dispute resolution and/or litigation that might arise in the conduct of the Company's business/relationships with external parties.
Provide day-to-day legal advice, in a pragmatic and collaborative manner, to assist the business in achieving its goals/objectives in a legally compliant and ethical manner.
Review, analyze and keep current on all federal and state legal developments affecting the pharmaceutical industry.
Support the Company's Government Affairs efforts directed toward relevant Federal and State policies and statues and their impact on the Company's commercialization.
Advise on and assist in developing and improving business processes and procedures to support new business models.
Collaborate with the Chief Financial Officer on activities related to corporate financing, external reporting and SEC compliance.
Collaborate with the President and COO on activities related to business and corporate development.
Collaborate with Chief Commercial Officer on activities related to global commercialization of Audentes products.
Required Education, Skills and Experience
JD and active California bar member with 8-10+ years of relevant legal experience with 5+ years' experience at a publicly traded commercial pharmaceutical, biotech, or medical device company.
Demonstrated experience providing counsel regarding the compliant marketing of pharmaceuticals, biologics and/or medical devices.
Proven experience with government price reporting compliance.
Prior success managing external legal counsel.
Strategic mindset, resourceful with a vast array of legal experience.
Collaborative, team-based/partnership approach.
An excellent strategist and negotiator.
Strong knowledge of licensing, financing, business development, product marketing, market research, sales, and manufacturing.
Strong global intellectual property understanding and experience.
A proven history overseeing complex biopharmaceutical patent strategy and in-depth patent experience.
Demonstrated experience drafting, reviewing and negotiating a wide variety of agreements.
Exceptional written and communication skills, including strong proofreading and editing skills.
Must be a self-motivated, hands-on executive who functions effectively in an entrepreneurial, high-energy team environment.
Preferred Skills and Experience
5+ years of direct management of a legal team/organization
Rare disease or gene therapy experience
Litigation experience
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