Director, Intellectual Property

Director, Intellectual Property

Amylyx has an audacious mission to usher in a new era for treating diseases with high unmet needs. Where others see challenges, we see opportunities that we pursue with urgency, rigorous science, and unwavering commitment to the communities we serve. We are a clinical-stage company currently focused on post-bariatric hypoglycemia (PBH), Wolfram syndrome, and amyotrophic lateral sclerosis (ALS).

Our mission is powered by our people. Our core values – be audacious, be curious, be authentic, be engaged, and be accountable – creating a culture of caring. Amylyx has assembled an experienced team ready to take action because the communities we serve have no time to wait. If you share our passion and are determined to tackle some of medicine's toughest problems, we encourage you to read the opportunity below.

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.

Compensation

The pay range posted below represents our good faith estimate of compensation for this role, based on market data and internal benchmarks. The final offer may vary depending on a candidate's experience, skills, and qualifications, as well as considerations of internal equity.

Estimated Pay Range $245,000 —$276,000 USD

Amylyx Pharmaceuticals is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, pregnancy-related conditions, and lactation), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, or any other characteristic protected by applicable federal, state, or local laws and ordinances. Amylyx's management team is dedicated to this policy with respect to recruitment, hiring, placement, promotion, transfer, training, compensation, benefits, employee activities, access to facilities and programs, and general treatment during employment. Accommodations are available for candidates who require them in our selection process. If you need an accommodation, please let your Amylyx Talent Acquisition contact know.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.