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GMP ALLIANCE MANAGER, DHVI PRODUCT DEVELOPMENT

Req ID:  5354
Date:  Nov 15, 2019
Location: 

Durham, NC, US, 27710

Personnel Area:  MEDICAL CENTER

School of Medicine:

 

Established in 1930, Duke University School of Medicine is the youngest of the nation’s top medical schools. Ranked tenth among its peers, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where traditional barriers are low, interdisciplinary collaboration is embraced, and great ideas accelerate translation of fundamental scientific discoveries to improve humanhealth locally and around the globe.

 

Comprised of 2,400 faculty physicians and researchers, the Duke University School of Medicine along with the Duke University School of Nursing and Duke University Health System create Duke Health. Duke Health is a world-class health care network. Founded in 1998 to provide efficient, responsive care, the health system offers a full network of health services and encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Private Diagnostic Clinic, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.

 

The Alliance Manager, DHVI Product Development will be responsible for working closely with the Director, DHVI Product Development, the Director, DHVI and portfolio managers and sponsoring and partnering organizations to support vaccine and product development activities.  This is a critical senior leadership role that will play a major role in the development of new vaccines and/or monoclonal antibodies for use to protect or treat those with infectious diseases such as HIV, Influenza and TB, with a focus on ensuring stability within the product development and manufacturing portfolio, and close integration with sponsoring government agencies and strategic development partners.

 

RESPONSIBILITIES:

  • Work closely with clinical development leadership to guide vaccine and product development activities to utilize resources and invested capital efficiently and effectively to achieve organizational objectives.
  • Conduct strategic planning processes, including facilitating the development of strategic priorities and annual organization goals that aid in achieving strategic objectives.
  • Develop integrated product development plans to drive alignment within DHVI teams and sponsoring and partnering external organizations.
  • Provide well-researched advice and guidance on scientific, regulatory, manufacturing, clinical development, IP and licensing issues for the product portfolio. Input would be at level of scientific meetings (data discussions), principal investigator (PI) meetings, product planning meetings, and clinical development and related meetings.
  • Provide research and guidance on vaccine product landscape outside of NIH, to guide clinical development plans, including vaccine target product profiles (TPP).
  • Provide advice, input and written guidance on patents (e.g.., Flu, RSV, HIV vaccines, antibodies, etc.). Participate in deliberations and provide advice on technology transfer agreement and licensing discussions. Work with DHVI Intellectual Property and Contracts Directors, interface with companies, or the Business Development Office.
  • Provide input into development of strategies to address current FDA requirements, review and support regulatory submissions, and help develop strategies to move novel technologies from the laboratory to the clinic in a safe and compliant manner.
  • Provide input into strategic and tactical planning, monitor pitfalls, and review/provide input to research conducted to inform the development of improved HIV-1 and biodefense and emerging/re-emerging infectious disease vaccine immunogens.
  • Lead Governance team in regards to capacity, readiness of products, forecasting needs and resources required.
  • Interface with companies, and partnering agencies such as NIH Division of AIDS, IAVI, the Gates Foundation, CMOs, and others as needed
  • Prepare oral and written presentations, as needed, for both internal and external use.
  • Prepare monthly updates to DHVI leadership and alert leadership timely to adverse findings for developments that may impact the DHVI mission. 
  • Work closely with DHVI Product Development team to develop and utilize stage gates for program management, analysis of potential resource and investment requirements, and the efficient and effective utilization of development and manufacturing resources.

 

 

 Minimum Qualifications

 

 

 

Education

Relevant Bachelor’s degree. PhD or Masters in relevant Science or Engineering discipline highly preferred; MBA a plus

9+ years of business development experience in the biologic / vaccine industry with an established track record of successfully establishing collaborations with industry and academic partners

 

Experience

 

Work requires a minimum of nine years progressively responsible 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. OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE

 

  • Strong knowledge of cGMP compliance and cGMP manufacturing operations with background in Protein Biologics in a cGMP Manufacturing environment required
  • Strong strategic and analytical skills including opportunity analysis with hands-on experience in structuring and negotiating business development, contracts, and licensing transactions.
  • A good understanding of finance required, including previous experience managing complex budgets 
  • Relevant business experience within a pharmaceutical/biotech company or related business
  • Strong interpersonal and communication skills for bridging scientific and business participants for effective internal collaboration as well as for interactions with potential partners
  • Sound business judgement with the ability to synthesize and summarize a complex set of facts and set opportunities within the broader strategic context
  • Demonstrated leadership experience with strong understanding of drug discovery and development process
  • Comfortable with public speaking and delivering presentations
  • Proven project management abilities with demonstrated experience building and leading exceptional teams

 

 

Duke University 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 essential job 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.

 


Nearest Major Market: Durham
Nearest Secondary Market: Raleigh