Vice President, Head of Intellectual Property

Zenas BioPharma•Waltham, MA

20h•Hybrid

About The Position

Zenas is a clinical-stage global biopharmaceutical company committed to becoming a leader in the development and commercialization of transformative therapies for patients with autoimmune diseases. Our core business strategy combines our experienced leadership team with a disciplined product candidate acquisition approach to identify, acquire and develop product candidates globally that we believe can provide superior clinical benefits to patients living with autoimmune diseases. Zenas is advancing two late-stage, potential franchise molecules, obexelimab and orelabrutinib. Obexelimab, Zenas’ lead product candidate, is a bifunctional monoclonal antibody designed to bind both CD19 and FcγRIIb, which are broadly present across B cell lineage, to inhibit the activity of cells that are implicated in many autoimmune diseases without depleting them. We believe that obexelimab’s unique mechanism of action and self-administered, subcutaneous injection regimen may broadly and effectively address the pathogenic role of B cell lineage in chronic autoimmune disease. Orelabrutinib is a potentially best-in-class, highly selective CNS-penetrant, oral, small molecule Bruton’s Tyrosine Kinase (BTK) inhibitor with the potential to address compartmentalized inflammation and disease progression in Multiple Sclerosis (MS). Zenas’ earlier stage programs include a preclinical, potentially best-in-class, oral, IL-17AA/AF inhibitor, and a preclinical, potentially best-in-class, oral, brain-penetrant, TYK2 inhibitor. We are seeking top talent who share our commitment to patients and have a track record of success in acquiring, developing and commercializing products across the globe. Our colleagues have an opportunity to engage in a fast-paced learning environment and experience individual and organizational success as we work towards becoming a global immunology and autoimmune disease leader, while living our values of Transparency, Relationships, Urgency, Excellence and Innovation – TRUE Innovation! Position Summary: The Vice President, Head of Intellectual Property will lead our intellectual property (IP) function globally, including patent strategy as well as trademark protection. This individual will serve as the company’s subject matter expert on IP matters, and work closely with our research, development and technical operations colleagues to ensure patentable inventions are captured and protected. The ideal candidate will be strategic and seasoned with hand’s-on in-house biotech experience preferably in both biologics and small molecules. This position will report to the Chief Legal Officer and be based in our Waltham, MA headquarters location.

Requirements

Bachelor's degree in a relevant scientific discipline (e.g. biology, biochemistry, molecular biology, pharmacology, chemistry, or a related field); advanced degree strongly preferred
J.D., active USPTO registration (patent bar), and bar membership in at least one U.S. jurisdiction; current license to practice in Massachusetts preferred
8-13 years of patent law experience, with meaningful life sciences exposure (in-house or at a law firm) and direct experience with antibody and/or small molecule patents; experience in-house biotechnology or pharmaceutical company experience preferred
Demonstrated experience managing a complex, global patent portfolio and overseeing prosecution through outside counsel
Solid understanding of Hatch-Waxman and/or BPCIA regulatory frameworks and related patent litigation
Familiarity with Orange and Purple Book listing requirements and regulatory (data) exclusivity mechanisms
Experience conducting or overseeing IP due diligence, including FTOs or similar analyses
Strong scientific curiosity and acumen, and the ability to engage credibly with research and clinical teams
Ability to communicate effectively and clearly to a diverse set of audiences ranging from junior employees to senior executives to the board of directors
Strong analytical and problem-solving skills; ability to think creatively and develop innovative IP strategies; adaptability and nimbleness in a fast-moving environment
Comfortable working in a demanding, fast-paced, start-up culture with evolving processes. Flexible and able to adapt to new situations as the business demands.

Responsibilities

Own the development and execution of a global IP strategy for a portfolio of antibodies and small molecules designed for patients with autoimmune diseases, from early research to clinical to commercial stage, and ranging from initial composition of matter to formulation/CMC to lifecycle management
Build, manage, expand, and optimize our portfolio across patent types, including composition of matter, method of treatment, formulation, dosing, manufacturing, and biomarker claims
Serve as the patent advisor to the organization as we transition from a clinical-stage biotech to a commercial company, ensuring IP goals are met within timeline and quality standards
Collaborate closely with our R&D, clinical, and manufacturing teams to identify and capture inventions in a timely and comprehensive manner; advise on IP implications of development activities and decisions; support publication and data generation strategies
Oversee outside counsel managing our global patent portfolio and supervise the prosecution of patent applications in the US and globally
Work with our in-license and out-license partners as applicable, to ensure global protection and coordination
Create and implement comprehensive patent lifecycle strategies across the pipeline; including developing effective secondary IP filing strategy to extend and strengthen exclusivity
Oversee all regulatory exclusivity matters, including potential listings (e.g. FDA Orange and Purple Book) and the interplay between regulatory and patent protections
Lead IP due diligence in connection with business development and licensing activities, including evaluation of IP assets such as exclusivity, patentability, validity, and enforceability and assessing freedom-to-operate risk
Draft and negotiate IP-related provisions in research collaborations, license agreements, material transfer agreements (MTAs), and other commercial contracts
Monitor the competitive patent landscape for potential risks and opportunities; advise leadership team and the Board on relevant updates and related strategies
Protect our brands by managing trademark portfolios as well as outside trademark counsel, working with our corporate and commercial teams and other stakeholders
Manage and protect the company's trade secrets, know-how, and proprietary information and implement procedures for trade secret protection
Develop and maintain IP policies and procedures, including invention disclosure, record-keeping, and outside counsel management protocols
Manage IP budget, including outside counsel spend, annuity and maintenance fees
Educate and train internal stakeholders on IP strategy, policies, invention disclosure processes, and best practices for protecting confidential information