Director, Clinical Operations

Employer
University of Pennsylvania
Location
Philadelphia
Closing date
Jul 15, 2033

Job Details



Director, Clinical Operations

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.

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
Director, Clinical Operations

Job Profile Title
Director D

Job Description Summary
The Gene Therapy Program (GTP) is entering a new era of unprecedented opportunity with the great potential to reshape the face of medicine as we know it. Our discoveries have set the stage for successful treatments and possibly even cures for devastating genetic diseases.

The laboratory of Dr. Jim Wilson, at GTP of the University of Pennsylvania, has been a leader in the development of innovative vector technology for close to three decades. We have emerged as the “go-to” organization for public and private partners, who want to participate in the gene therapy space. Currently, we are positioned to lead another round of vector innovation and establish pre-clinical and clinical proof-of-concept in therapeutic applications of in-vivo genome editing.

Continuation of all GTP positions is contingent upon funding.

Job Description

Due to continued growth of our program, we are searching for a Director, Clinical Operations that will oversee the strategy for implementation and the execution of all clinical trials for GTP.

As the Director, Clinical Operations, you will have experience driving a pre-clinical study into Phase I and through clinical development. You will also ensure that clinical stage programs achieve program objectives within established timelines, budget, and quality standards. Working with the GTP leadership, you will ensure that the appropriate company infrastructure and quality systems are in place to support all clinical trials (US and exUS). You take the lead in selecting external vendors that will support clinical operations, developing strong relationships and managing all contractual agreements. You will lead the clinical operations team in the execution of clinical studies in conformance with Good Clinical Practices (GCP), International Conference of Harmonization (ICH) Guidelines and Penn Standard Operating Procedures.

Qualified candidates will have a background in life sciences and end-to-end clinical operations experience from working within biotech or pharmaceutical industry. Experience supporting clinical trials for rare disease indications is preferred.

Joining GTP offers clinical research professionals the unique opportunity of seeing research go from bench to bedside and discoveries that could one day lead to cures.

Qualifications:
  • BS degree in Life Sciences, Public Health or other related discipline, with 7+ years of experience in Clinical Operations within biotech or pharmaceutical industry required. Record of success in positions of increasing responsibility in study execution is also required.
  • Advanced degree preferred e.g. MS, PhD.
  • Clear understanding and experience applying ICH/GCP.
  • Advanced understanding of drug development processes and key operational interfaces.
  • Proven track record in operational delivery of phase 1-3 global clinical trials - results orientated.
  • Strong scientific/therapeutic expertise in rare diseases preferred.
  • Demonstrated ability to plan, organise and manage resources to bring to successful completion specific study or project goals and objectives in accordance with defined quality and time based metrics.
  • Demonstrated expertise in the identification, evaluation and selection of key global preferred provider partnerships.
  • Thorough understanding of local and international regulations applicable to clinical development; demonstrative knowledge of regulatory requirements globally and prior success in providing timely and quality support of regulatory submissions.
  • Excellent interpersonal communication skills and proven team leadership and team playing characteristics.
  • Advanced ability to problem solve.
  • Proven ability to influence and negotiate with key internal and external stakeholders.
  • Proven ability to manage large budget.
  • Demonstrated success working independently and taking decisions with minimal supervision.


Job Location - City, State
Philadelphia, Pennsylvania

Department / School
Perelman School of Medicine

Pay Range
$88,861.00 - $168,837.00

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.


To apply, visit https://wd1.myworkdaysite.com/en-US/recruiting/upenn/careers-at-penn/job/Translational-Research-Laboratories/Director--Clinical-Operations_JR00022796-1





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Company

Welcome to the University of Pennsylvania! Penn is the largest private employer in Philadelphia and is a world-renowned leader in education, research, and innovation.  

Across our 12 highly-regarded schools, more than 25,000 students, and more than 4,000 faculty members, we become one university: a wide-ranging, ever-changing community that draws its strength from a multitude of races, ethnicities, genders, sexual orientations, historical traditions, ages, religions, disabilities, veteran status, interests, perspectives, and socioeconomic backgrounds. 

Penn carries on the principles and spirit of its founder, Benjamin Franklin: entrepreneurship, innovation, invention, outreach, and a pragmatic love of knowledge. Franklin's practical outlook has remained a driving force in the university's development. To learn more, visit About Penn

Vision

 

As engines of knowledge and new ideas, universities have the unique potential to define the future rather than be defined by it; to pioneer change rather than merely manage it. To do so requires a plan both visionary and pragmatic. The Penn Compact 2022 motivates community members to innovate, be radically inclusive, and positively impact their local, national, and global communities. 

 

Penn’s fundamental priorities — increasing access, integrating knowledge and engaging locally, nationally and globally — are supported by the three core values that make us uniquely Penn: inclusion, innovation, and impact. 

 

Learn about the signature initiatives of the Penn Compact 2022:  

 

Diversity 

 

Understanding and appreciating diversity is one of Penn's most important priorities and is fundamental to success in today's world. 

 

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. 

 

To learn more about Diversity and Inclusion at Penn visit: 

 

Benefits 

 

Penn offers a wide range of benefits and perks - from Penn's retirement Matching Plan to bike repair stations to access to the full LinkedIn Learning library to adoption assistance to workshops at the letterpress and book arts studio and much more! 

 

Campus and Beyond

 

We invite you to explore our campus and its stately buildings and state-of-the-art facilities. 

 

Try our self-guided tour! Come and visit

 

Learn about sustainability at Penn

 

News 

 

Stay up-to-date with Penn's response to COVID-19: Coronavirus Information & Resources

 

Penn supports news publications that tell the ongoing story of the University community, communications services for external media, telephone and video services, and other media resources: Campus Media 

 

Connect with us!  

 

Instagram: @uofpenn 

Twitter: @Penn 

 

 

Find Us
Telephone
(215) 898-7372
Location
3451 Walnut Street
Philadelphia
PA
19104
United States

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