Director Of Intellectual Property

School of Medicine Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where interdisciplinary collaboration is embraced and great ideas accelerate translation of fundamental scientific discoveries to improve human health locally and around the globe. Composed of more than 2,500 faculty physicians and researchers, more than 1,300 students, and more than 6,000 staff, the Duke University School of Medicine along with the Duke University School of Nursing, Duke University Health System and the Private Diagnostic Clinic (PDC) comprise Duke Health. a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.

 

 

 

DIRECTOR OF INTELLECTUAL PROPERTY JOB DESCRIPTION

 

 

PURPOSE

 

The Duke Human Vaccine Institute (DHVI) is a Duke-based research institute that conducts cutting edge vaccine research against infectious diseases of global importance. The investigators at DHVI conduct basic and translational research to develop novel vaccines, therapeutics and diagnostics for diseases such as HIV-1, tuberculosis, influenza, malaria, ebola, zika, cytomegalovirus and most recently, SARS-CoV-2 (COVID-19). DHVI is home to several large grants and contracts funded by the National Institutes of Health (NIH) National Institute of Allergy and Infectious Diseases (NIAID), Division of AIDS (DAIDS) including CHAVD, IVQAC, IPCAVD, as well as DARPA and CIVICs Programs. DHVI is a cradle-to-grave organization whose faculty and staff focus on discovery, to manufacturing, to human clinical trials. DHVI has a Good Manufacturing Practice (GMP) Facility. The GMP Facility includes five manufacturing suites featuring state of-the-art single-use equipment for the manufacture of HIV antigens, mRNA therapies and vaccines, and other cell or bacterial-based products.   

 

This full-time position reports directly to the DHVI Associate Chief Operating Officer with a dotted line to the Office for Translation & Commercialization (OTC) and the Office of Research Contracts (ORC) of Duke University Medical Center.

 

Summary: In collaboration with the stated partners, the Senior Director is responsible for management of all aspects of Intellectual Property (IP) across all DHVI Research and GMP Product Development and Manufacturing Programs. 

 

RESPONSIBILITIES AND ACCOUNTABILITIES

 

(45%) Intellectual Property Strategy and Patent Portfolio Management:

• Develop intellectual property strategies, actively manage outside counsel in the development, prosecution, and maintenance of a patent portfolio covering DHVI technology and discoveries. Interact and coordinate with DHVI inventors to identify new inventions; review of invention disclosures to determine inventorship, federal compliance, and patent filing priorities. Review all invoices from outside firms for payment and manage allocated annual budget.

 

• Perform patentability searches to understand the prior art landscape, evaluate patentability and assist with development of allowable patent claims.

 

• Work directly with and coordinate interactions with outside counsel in the preparation, filing, prosecution, and maintenance of the DHVI portfolio. Provide advice and review to outside counsel for the filing and prosecution of provisional and non-provisional patent applications and actively manage the patent budget in doing so.

 

 

(15%) Research Agreements and Federal Agencies Reporting

• Understand IP provisions of funding announcements and agreements relating to DHVI research, including federal, foundation and industry funding agreements, material and data transfer agreements, and collaboration agreements, and advise DHVI staff on rights and obligations under those agreements.

 

• Coordinate the filing of invention reports to federal agencies with the OTC. Make required invention reports to non-federal entities as required by agreements related to DHVI research. Work with DHVI leadership and OTC to manage and develop patent portfolio with regard to creating licensing opportunities, and protecting IP in the context of agreements relating to DHVI research.

 

• Provide knowledgeable input on terms of agreements relating to DHVI research, and assist in the negotiation of those agreements.

 

• Utilize the OTC database to track the receipt, use and dissemination of materials, technologies, know-how and intellectual property to and from third party collaborators to maintain compliance with the terms of agreements relating to DHVI research and avoid inadvertent loss of IP rights.

 

• Interface and coordinate DHVI technology transfer, patenting and licensing activities with OTC and the Office of Corporate Research Collaborations (agreements).

 

• Develop an effective licensing strategy for DHVI technology and discoveries on which patents have been filed. Assist OTC in drafting and negotiating license agreements in alignment with Duke University policies and the terms of the applicable agreements.

 

(35%) GMP Product Development and Manufacturing Programs:

• Proactively engage GMP Director, DHVI Agreements Manager and DHVI Alliance Manager to ensure that appropriate agreements, including agreements for in-house manufacturing, outsourced services agreement, technology use/transfer or other agreements as may be required by GMP Programs are established, resourced, allocated and that potential challenges are recognized and addressed in a timely manner. Coordinate drafting, review and negotiation of such agreements.
• Establish mechanisms and communication channels with DHVI Program managers, DHVI GMP Product Development and Manufacturing Programs leadership and DHVI Communications Director as relevant to ensure Agreements and Programs goals, timelines and deliverables are aligned, and that information about Agreements and Programs goals, timelines and deliverables is shared with stakeholders in a timely manner.
• Primary DHVI liaison to internal and external partners for all DHVI IP, including newly developed IP, that which OTC will license, and technology transfer matters related to DHVI Research and GMP Product Development and Manufacturing Programs.
• Provide advice and guidance on IP regarding technologies and products for the DHVI GMP Product Development and Manufacturing Programs.

 

(5%) Perform other related duties as assigned by ACOO, DHVI Director, or other DHVI leadership.

 

MINIMUM QUALIFICATIONS

 

Education/ Experience: 

• Possesses at least 8 years' experience in a biotechnology/pharmaceutical company, law firm, or non-profit research organization.
• Advanced degree required in a relevant scientific discipline-MA/MS is required and PhD is highly preferred with experience in immunology, virology, molecular and cellular biology or another related scientific field.
• Certification to practice before the US Patent and Trademark Office is required.

 

Skills and Abilities:

• Strong communication, organizational and time management skills.
• Experience in technology transfer and/or IP management, both the non-profit and commercial sectors, strongly preferred.
• Experience in the review and negotiation of a broad range of IP and research related agreements.
• Experience in the management of intellectual property, including management of a patent docket and outside counsel.
• Ability to balance numerous projects with tight deadlines, and to switch projects quickly to accommodate shifting priorities and demands
• Ability to communicate effectively complex scientific and legal issues to both lay and specialist audiences to advance internal and external collaborations
• Strong scientific and legal knowledge to advise and strategically structure and negotiate contracts, licensing and partnership agreements
• Experience in public speaking and giving presentations
• Ability to work in a team environment collaborating with team members for successful IP management/operations.
• Commitment to upholding and engaging in behavior that reflects DHVI values including diversity, equity and inclusion

 

 

Duke University Medical Center is located in the energetic and progressive Research Triangle area of North Carolina.  Duke University is an Equal Opportunity/Affirmative Action Employer.

Minimum Qualifications

 

Education

Work requires a Bachelor's degree in Business Administration, Hospital Administration, Accounting or a closely related field.

 

Experience

 

Work requires a minimum of nine years progressively responsible OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE experience in administrative management, to include proficiency in budgeting, grants and contracts, personnel supervision and space and facilities management. A Master's degree in Business Administration, Hospital Administration, Accounting or a closely related field may substitute for two years of required experience.

 

Duke is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, sexual orientation, or veteran status.

 

Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas-an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.

 

Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essentialjob functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.