DIRECTOR, CLINICAL DEVELOPMENT

Job description

Posting Details

Posting Details

Reference Number 40-30645 Posted Job Title DIRECTOR, CLINICAL DEVELOPMENT School Name Perelman School of Medicine Org OD-Center for Orphan Disease Research and Therapy Posted to the Web 05/20/2019 Posted Job/Salary Grade 030 Employment Type Exempt Hours N/A Position Type Full Time Position Schedule 8am - 5pm Months 12 Position Length Contingent Upon Funding Position End Date 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.

School/Center Overview

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/

Duties

Orphan diseases represent a collection of disorders that afflict fewer than 200,000 individuals for any single disease type, yet there are more than 7,000 distinct orphan diseases. The Orphan Disease Center (ODC) in the Perelman School of Medicine was founded in 2011 to promote and fund research in rare diseases globally, beyond Penn, making a difference for these under-served patient populations. A unique aspect of ODC is that it is a ‘Center without walls’ which sources and contributes to developing transformative therapies through the use of platform technologies and of research strategies that can be deployed across multiple rare disease programs. The main feature is a pilot grant program which provides $8M annually to over 35 global institutions.

We are currently seeking a Clinical Development Scientist 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.

Qualifications

- 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.

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 Quick Link http://jobs.hr.upenn.edu/postings/43263 Posting Supplemental Questions

Required fields are indicated with an asterisk (*).

  1. * How did you hear about this employment opportunity?
    • [email protected]
    • Contacted by a Penn Recruiter
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  2. * What is your highest level of education completed?
    • Less than high school education
    • High School Diploma or GED
    • Vocational or Technical School
    • Associate's Degree or Two Year College
    • Bachelor's Degree
    • Master's Degree
    • PHD/MD/JD or equivalent doctoral degree
  3. * How many years of experience do you have related to this position?
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    • 1 to 2 Years
    • 2 to 3 Years
    • 3 to 5 Years
    • 5 to 7 Years
    • 7 to 10 Years
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Applicant Documents Required Documents
    Optional Documents
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    Job No:
    Posted: 5/21/2019
    Application Due: 6/29/2019
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