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Posted Job Title
Clinical Director, Orphan Disease Center
Job Profile Title
Job Description Summary
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 âœCenter without wallsâ 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.
Continuation of this position is contingent upon grant funding.
We are currently seeking a new role of ODC Clinical Director to build and drive strategy for clinical research activities related to Childhood Disintegrative Disorders (CDD) for the ODC.
As the ODC Clinical Director you will report directly to the Director and Executive Director of the Orphan Disease Center. You will work in collaboration with the CDKL5 Program of Excellence Director and external foundation partners of the ODC related to CDD's.
DUTY/SCOPE (including but not limited to):
â¢ You will provide strategic leadership on clinical development and operations to the CDKL5 PoE and external foundation partners in the development of therapeutics for CDD.
â¢ You will identify clinical needs in the CDD space and propose and lead clinical programs to address these needs, including in areas of biomarker discovery and development, clinical outcome measure validation, and epidemiological studies.
â¢ You will lead a pre-competitive international observational study in CDD in collaboration with a consortium of pharmaceutical companies, in the role of study Medical Director from concept protocol to final study report.
â¢ You will provide insight to novel pipeline opportunities to determine clinical feasibility and help identify clinical development opportunities.
â¢ You will provide medical support as needed to other clinical programs in development for CDD including non-interventional studies and investigator sponsored studies.
â¢ You will maintain and develop relationships with key opinion leaders, trial investigators, patient organizations, experts and consultants, regulators and other stakeholders.
â¢ You will manage and support internal and/or external (CRO) resources to execute the clinical programs and studies.
â¢ You will provide clinical leadership to the ODC patient registry, collaborating with ODC staff and CDD clinicians, patient organizations and regulators to support registry operations and maximize impact on clinical research.
Joining the ODC offers you a unique opportunity to contribute to revolutionizing the practice of medicine for these under-served patient groups.
â¢ MD in a relevant field (neurology, psychiatry) with 7 or more years of relevant experience required.
â¢ At least 5 years of relevant drug development experience within the biotech and pharmaceutical industry
â¢ Proven clinical development experience designing, implementing and conducting clinical trials, particularly for CNS disorders
â¢ Experience working with neurodevelopmental diseases, ideally in the rare disease space
â¢ Good understanding of rare disease clinical development challenges, ideally including gene therapy trials
â¢ Ability to develop and maintain relationships with professionals working at pharmaceutical companies and key opinion leaders, as well as with patient
Job Location - City, State
Department / School
Perelman School of Medicine
$126,841.00 - $240,998.00
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: JR00017090
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.