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Lupus Clinical Lead
Janssen R&D, a member of Johnson & Johnsons Family of companies, is
recruiting for a Lupus Clinical Lead, for the Estrela venture within the
Janssen Incubator, located in Spring House, PA.
Estrela is an entrepreneurial, scientifically-driven, Lupus-focused venture
team within the newly established Janssen Incubator of Janssen R&D. We
receive milestone-based funding and are leveraging external and Janssen R&D
functional support to progress bio-therapeutic assets to clinical
proof-of-mechanism in Lupus. We are committed to partnering with the
external health care community, delivering superior biomedicines, and
discovering patient-centric solutions for Lupus.
Thriving on a diverse company culture, celebrating the uniqueness of our
employees and committed to inclusion. Proud to be an equal opportunity
The Lupus Clinical Lead will partner closely with Estrela scientists to
drive the strategic design and execution of proof-of-mechanism Lupus
clinical studies to deliver on our venture goal and advance the Janssen R&D
Lupus portfolio. They will oversee Phase 0/1 study conduct including:
strategic collaborations with Lupus key opinion leaders; identification of
clinical sites and CROs that will participate in trials; review budgets and
timelines to ensure that trials are competitive; partner with internal or
external staff responsible for study execution, analysis and reporting;
review and interpret clinical trial data to enable timely internal
decision-making; external communication with investigators and regulatory
agencies; and oversee the preparation and assure the accuracy of INDs and
clinical study reports. The Lupus Clinical Lead will ensure adherence to
GCP and to all relevant internal and external guidances. If MD or MD/PhD,
this position will be responsible for medical monitoring and safety aspects
of Lupus clinical trials. If PhD, this position will partner closely with
assigned medical monitor to ensure safety aspects are fully compliant. The
Lupus Clinical Lead will prepare and/or direct the preparation and review
of protocols, clinical study reports, clinical pharmacology and
translational medicine sections of early development plans, IBs, INDs,
abstracts, manuscripts, and technical reports, as needed. In addition, the
Lupus Clinical Lead will be responsible for presentation of results and
updates at internal meetings.
A Ph.D with post-doctoral experience and 12 years of business experience,
or an M.D./Ph.D or M.D. with a minimum of 3 years industry experience is
required. Previous Lupus clinical research experience is required and
observational or interventional Lupus clinical trial experience is
preferred. Other required competencies include: fluency in written and
spoken English; working knowledge of the use of Microsoft suite of software
products including Excel, Word, and Power Point; the ability to advise,
persuade and negotiate with colleagues in a supportive and encouraging
fashion; strong presentation and project management skills; being able to
work in a cross-functional team environment; and willingness and ability to
travel up to 10% f the time. Good organizational skills with the ability to
multi-task and prioritize assignments and a record of peer reviewed
publication and experience in scientific presentations is preferred.
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