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 Pennâ™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 Development
Job Profile Title
Job Description Summary
The Perelman School of Medicine at the University of Pennsylvania is the oldest and one of the finest medical schools in the United States. Penn is rich in tradition and heritage and at the same time consistently at the forefront of new developments and innovations in medical education and research. Since its founding in 1765 the School has been a strong presence in the community and prides itself on educating the leaders of tomorrow in patient care, biomedical research, and medical education. http://www.med.upenn.edu/
We are currently seeking a Clinical Development Scientist/Director to design clinical development plans for multiple high-priority programs within the ODC. Reporting to the Deputy Director of the ODC, you will design end-to-end clinical development plans for multiple Orphan Disease programs. As part of this process, you will provide clinical and translational leadership to drive the design of natural history studies and early phase clinical trials. Close collaboration is required with the relevant rare disease experts, preclinical safety pharmacology lead, biomarkers and imaging specialists, and the Clinical Operations lead. As a key member of multi-disciplinary teams, you will work closely with other functional experts to progress research projects to IND readiness. You will provide clinical development advice and strategic guidance to external academic and industry partners who, as regulatory Sponsors, will be accountable for interventional clinical trial execution. You will be accountable for design, implementation and effective conduct of non-interventional natural history studies and patient registries; contributing to the development of regulatory briefing documents, clinical protocols and clinical elements of regulatory submission documents. You will develop an external key opinion leader network and relationships with patient advocacy groups to bring scientific, patient and medical expert insight to development programs You will also contribute to the organization of and participation in external Advisory board meetings and Orphan Disease think tanks Joining the ODC offers you the unique opportunity to contribute to revolutionizing the practice of medicine for these under-served patient groups.
- Masters Degree in life sciences or equivalent experience
- 5+ years experience in clinical trial management
- Hands-on experience in global clinical trial conduct and operations and demonstrated ability to deliver clinical studies on time and on budget.
- Possess detailed knowledge of GCP and other regulations governing clinical studies -Rare diseases experience highly desirable.
Job Location - City, State
Department / School
Perelman School of Medicine
$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.
Internal Number: JR00002872
About University of Pennsylvania
Penn has a long and proud tradition of intellectual rigor and pursuit of innovative knowledge, begun by Benjamin Franklin in 1740. That tradition lives today through the creativity, entrepreneurship, and engagement of our faculty, students, and staff. Academic life at Penn is unparalleled, with an undergraduate student body of 10,000 from every U.S. state and around the world. The entering class of 2015 is the most talented and diverse in Penn's history. Consistently ranked among the top 10 universities in the country, Penn welcomes an additional 10,000 students to our top-ranked graduate and professional schools.