The Opportunity

The Director, Intellectual Property, will be a key team member in the company’s growing IP function and support the development of the company’s IP portfolio. Reporting to the Vice President, Head of Intellectual Property, this role will develop and execute strategies towards building durable IP protections on the company’s molecules and programs. The ideal candidate will have a strong core expertise in patent enforcement of therapeutics, with end-to-end experience in patent matters from early R&D stage portfolio building to post-approval dispute resolution with generics. The role will also advise on trademark and IP-related contractual matters and is ideal for a patent-focused candidate seeking to grow into an IP generalist role.

Responsibilities

• Lead strategic patent portfolio development and litigation readiness strategies related to Amylyx’s clinical and pipeline molecules as assigned
• Support efforts in pursuing regulatory exclusivities, e.g., pediatric exclusivity and orphan drug exclusivity
• Perform IP assessments, including IP diligence in support of business development efforts, freedom-to-operate, patentability, validity, and competitive intelligence as assigned
• Monitor IP case-law and policy development, advise on impact, and develop best practice and/or risk mitigation strategies
• Support transactional efforts, including drafting and direct negotiation of IP-related contractual terms, e.g., in connection with license, collaboration, manufacturing, clinical development, and R&D contracts; advise stakeholders on post-execution impact and compliance of IP contractual terms
• Manage day-to-day patent prosecution efforts related to clinical and pipeline molecules as assigned, including drafting patent applications and managing US and ex-US outside counsel
• Monitor R&D, clinical, and manufacturing activities towards identifying potential IP protection opportunity; review proposed publications, presentations, and other public releases to ensure alignment with patent strategy
• Manage global trademark portfolio through outside counsel and perform clearance assessments as needed

Required Qualifications

• 10+ years of experience overall with ideally 7+ years of demonstrated experience in patent matters, specifically in the pharmaceutical and/or biotech industries and 5+ years law firm experience
• J.D. degree, member in good standing of at least one state bar, and registration to practice before the U.S. Patent and Trademark Office
• Advanced degree, e.g., M.S. or Ph.D., or equivalent industry experience in chemistry, biochemistry, biology, or other life science-related discipline
• Significant demonstrated patent experience in pharmaceutical/biotech therapeutics, e.g., small molecules, peptides, oligonucleotides. proteins, and/or biologic therapeutics
• Supporting or managing Hatch-Waxman patent litigation, litigation readiness efforts, and/or IPRs
• Advising on regulatory exclusivities, e.g., new-chemical entity exclusivity, orphan drug exclusivity, pediatric exclusivity, as well as on patent term extensions
• Conducting patentability, freedom-to-operate, due diligence, and validity assessments
• Global patent prosecution experience, including drafting patent applications and day-to-day prosecution tasks
• Ability to deliver solution-focused and fit-for-purpose guidance on complex matters, drive initiatives and cross-functional alignment, and impact and influence organization

Preferred Requirements

• Ph.D. in life-science-related discipline
• Structuring, drafting and negotiating IP-related aspects of contracts, e.g., license, collaboration, R&D, manufacturing, and/or clinical development contracts
• Patent experience in both brand-side and generic-side therapeutics
• Trademark prosecution

Work Location and Conditions

• At Amylyx, we proudly support remote work opportunities within the United States. However, due to business considerations related to health insurance coverage and state tax regulations, we are unable to hire employees who reside and/or work in certain states. Currently, we are not considering applicants from Alaska and Hawaii.
• You will be expected to travel to our corporate location in Cambridge, MA several times a year and attend other company-related events as necessary and requested.
• You must have access to work in setting which enables meeting all requirements of the role (including privacy, reliable internet access, phone, ability to video conference, etc.) at your remote location.