Director, Clinical Operations
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Posted Job Title
Director, Clinical Operations
Job Profile Title
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.
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.
- 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
Department / School
Perelman School of Medicine
$88,861.00 - $168,837.00
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