Associate Director of Translational Science Operations (Center for Cellular Immunotherapy)

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Associate Director of Translational Science Operations (Center for Cellular Immunotherapy)

 


University Overview

The University of Pennsylvania, the largest private employer in Philadelphia, is a world-renowned leader in education, research, and innovation. This historic, Ivy League school consistently ranks among the top 10 universities in the annual U.S. News & World Report survey. Penn has 12 highly-regarded schools that provide opportunities for undergraduate, graduate and continuing education, all influenced by Penn's distinctive interdisciplinary approach to scholarship and learning. As an employer Penn has been ranked nationally on many occasions with the most recent award from Forbes who named Penn one of America's Best Employers By State in 2021.

Penn offers a unique working environment within the city of Philadelphia. The University is situated on a beautiful urban campus, with easy access to a range of educational, cultural, and recreational activities. With its historical significance and landmarks, lively cultural offerings, and wide variety of atmospheres, Philadelphia is the perfect place to call home for work and play.

The University offers a competitive benefits package that includes excellent healthcare and tuition benefits for employees and their families, generous retirement benefits, a wide variety of professional development opportunities, supportive work and family benefits, a wealth of health and wellness programs and resources, and much more.

Posted Job Title
Associate Director of Translational Science Operations (Center for Cellular Immunotherapy)

Job Profile Title
Associate Director E

Job Description Summary
This position reports to the CCI Director for Translational Sciences Operations to manage and direct CCI initiated Clinical Trials. This position independently manages the translational, regulatory, and operational aspects for the initiation, conduct, oversight, and data analysis of cell and gene therapy clinical trials initiated in the CCI. These trials include first-in-human clinical development in collaboration with industry partners or otherwise. The Associate Director of Translational Sciences will also manage relationships with other funding agencies, such as private foundations and bio-pharmaceutical companies. The Associate Director will work in a highly cross-functional environment and interact accordingly with the internal and external research groups to lead the transition of candidate gene therapy products into the clinic. These leadership activities will include evaluating the progression and milestones related to moving new targets into clinical studies and coordinating the optimization of cell and gene therapy product manufacturing processes. The Associate Director will develop and implement regulatory strategies; essential regulatory functions will include preparation of preclinical data packages for regulatory submissions, regulatory documentation including IND applications, IND amendments, responses to regulatory agency queries and annual reports. A major area of focus will be navigating the regulatory pathway enabling successful opening of INDs involving gene editing and CRISPR technologies. Regular interactions with clinical personnel to develop clinical protocols as well as other regulatory documents and contribute to clinical manuscripts are required of the Associate Director. The Associate Director will provide leadership to drive clinical trial timelines, and participate in the management of intellectual property, budget management, planning and reporting for specific projects assigned to the position. The Associate Director will oversee at least two (2) direct reports and will be is responsible for the training and onboarding processes of direct reports and other new team members.

Job Description

This position reports to the CCI Director for Translational Sciences Operations to manage and direct CCI initiated Clinical Trials. This position independently manages the translational, regulatory, and operational aspects for the initiation, conduct, oversight, and data analysis of cell and gene therapy clinical trials initiated in the CCI. These trials include first-in-human clinical development in collaboration with industry partners or otherwise. The Associate Director of Translational Sciences will also manage relationships with other funding agencies, such as private foundations and bio-pharmaceutical companies. The Associate Director will work in a highly cross-functional environment and interact accordingly with the internal and external research groups to lead the transition of candidate gene therapy products into the clinic. These leadership activities will include evaluating the progression and milestones related to moving new targets into clinical studies and coordinating the optimization of cell and gene therapy product manufacturing processes. The Associate Director will develop and implement regulatory strategies; essential regulatory functions will include preparation of preclinical data packages for regulatory submissions, regulatory documentation including IND applications, IND amendments, responses to regulatory agency queries and annual reports. A major area of focus will be navigating the regulatory pathway enabling successful opening of INDs involving gene editing and CRISPR technologies. Regular interactions with clinical personnel to develop clinical protocols as well as other regulatory documents and contribute to clinical manuscripts are required of the Associate Director. The Associate Director will provide leadership to drive clinical trial timelines, and participate in the management of intellectual property, budget management, planning and reporting for specific projects assigned to the position. The Associate Director will oversee at least two (2) direct reports and will be is responsible for the training and onboarding processes of direct reports and other new team members.

Masters or equivalent degree and 5-7 years accumulated experience in translational research (Cancer biology /T cell immunology/Gene editing preferred), regulatory and management activities associated with human research or equivalent combination of education and experience required. PhD strongly preferred. Knowledge of GLP and GMP, ability to accurately work under deadline pressure, demonstrated track record of successfully submitting IND applications, opening clinical trials, administrative, communication, and program management skills. Experience with IND applications involving gene editing or CRISPR technology highly favored.

This position is contingent upon funding.

Job Location - City, State
Philadelphia, Pennsylvania

Department / School
Perelman School of Medicine

Pay Range
$72,837.00 - $138,391.00

Affirmative Action Statement
Penn adheres to a policy that prohibits discrimination on the basis of race, color, sex, sexual orientation, gender identity, religion, creed, national or ethnic origin, citizenship status, age, disability, veteran status, or any other legally protected class.

Special Requirements
Background check required after a conditional job offer is made. Consideration of the background check will be tailored to the requirements of the job.

University Benefits

 

 

  • Health, Life, and Flexible Spending Accounts: Penn offers comprehensive medical, prescription, behavioral health, dental, vision, and life insurance benefits to protect you and your family's health and welfare. You can also use flexible spending accounts to pay for eligible health care and dependent care expenses with pre-tax dollars.
  • Tuition: Take advantage of Penn's exceptional tuition benefits. You, your spouse, and your dependent children can get tuition assistance here at Penn. Your dependent children are also eligible for tuition assistance at other institutions.
  • Retirement: Penn offers generous retirement plans to help you save for your future. Penn's Basic, Matching, and Supplemental retirement plans allow you to save for retirement on a pre-tax or Roth basis. Choose from a wide variety of investment options through TIAA and Vanguard.
  • Time Away from Work: Penn provides you with a substantial amount of time away from work during the course of the year. This allows you to relax, take vacations, attend to personal affairs, recover from illness or injury, spend time with family—whatever your personal needs may be.
  • Long-Term Care Insurance: In partnership with Genworth Financial, Penn offers faculty and staff (and your eligible family members) long-term care insurance to help you cover some of the costs of long-term care services received at home, in the community or in a nursing facility. If you apply when you're newly hired, you won't have to provide proof of good health or be subject to underwriting requirements. Eligible family members must always provide proof of good health and are subject to underwriting.
  • Wellness and Work-life Resources: Penn is committed to supporting our faculty and staff as they balance the competing demands of work and personal life. That's why we offer a wide variety of programs and resources to help you care for your health, your family, and your work-life balance.
  • Professional and Personal Development: Penn provides an array of resources to help you advance yourself personally and professionally.
  • University Resources: As a member of the Penn community, you have access to a wide range of University resources as well as cultural and recreational activities. Take advantage of the University's libraries and athletic facilities, or visit our arboretum and art galleries. There's always something going on at Penn, whether it's a new exhibit at the Penn Museum, the latest music or theater presentation at the Annenberg Center, or the Penn Relays at Franklin Field to name just a few examples. As a member of the Penn community, you're right in the middle of the excitement—and you and your family can enjoy many of these activities for free.
  • Discounts and Special Services: From arts and entertainment to transportation and mortgages, you'll find great deals for University faculty and staff. Not only do Penn arts and cultural centers and museums offer free and discounted admission and memberships to faculty and staff. You can also enjoy substantial savings on other goods and services such as new cars from Ford and General Motors, cellular phone service plans, movie tickets, and admission to theme parks.
  • Flexible Work Hours: Flexible work options offer creative approaches for completing work while promoting balance between work and personal commitments. These approaches involve use of non-traditional work hours, locations, and/or job structures.
  • Penn Home Ownership Services: Penn offers a forgivable loan for eligible employees interested in buying a home or currently residing in West Philadelphia, which can be used for closing costs or home improvements.
  • Adoption Assistance: Penn will reimburse eligible employees on qualified expenses in connection with the legal adoption of an eligible child, such as travel or court fees, for up to two adoptions in your household.




To learn more, please visit: https://www.hr.upenn.edu/PennHR/benefits-pay


To apply, visit https://wd1.myworkdaysite.com/en-US/recruiting/upenn/careers-at-penn/job/Smilow-Center-for-Translational/Associate-Director-of-Translational-Science-Operations--Center-for-Cellular-Immunotherapy-_JR00040395-1





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