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R&D

Senior Director, Head Clinical Development - Rare Disease

  • Titel Senior Director, Head Clinical Development - Rare Disease
  • Fungsi R&D
  • Sub Fungsi Clinical Research MD
  • Location Spring House, Pennsylvania, United States
  • Posted
  • ID Permintaan 2206037934W
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Deskripsi

Janssen Research and Development, L.L.C., a member of Johnson and Johnson's Family of Companies, is recruiting for a Senior Director, Head Clinical Development – Rare Disease , to be located in Spring House, PA .  Remote work options may be considered on a case-by-case basis and if approved by the Company.
 
At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.

As Immunology Leaders, we know immunology is vital to human health. Driven by a relentless focus on patient unmet needs, we will redefine treatments for immune diseases by delivering transformational and accessible therapies and regimens to patients with immune-mediated disease. For more than two decades we have been a world leader in the development of transformational medicines, establishing one of the strongest, first-in-class portfolios and pipelines in the industry, including the first tumor necrosis factor (TNF) inhibitor, and first interleukin (IL)-12 and IL-23 inhibitors. We tirelessly push the boundaries of science and creativity, applying our deep disease insights, novel pathway science, new technologies, and treatment modalities to restore immune homeostasis.


Janssen Research & Development, LLC. discovers and develops innovative medical solutions to address important unmet medical needs in the following therapeutic areas: immunology, oncology, neuroscience, infectious diseases & vaccines, cardiovascular & metabolism, and pulmonary hypertension. Please visit http://www.JanssenRnD.com for more information. 
 
We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it. We are guided by our Credo .
 
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
 

The Head of Rare Disease position is responsible and accountable for excellence in Clinical Science and late stage Rare Disease Clinical Development within the Therapeutic Area. The Senior Director, rare Disease supports the design, implementation and reporting of all Late-stage Phase II and III Rare Disease clinical trials in Janssen’s Immunology development portfolio. They are responsible for ensuring the Rare Disease portfolio is executed to schedule and meets the needs of patients, Regulators and Commercial stakeholders.  The successful candidate will have exceptional clinical development, functional-leadership and communications skills as well as a high degree of curiosity, innovation, entrepreneurship and a keen sense of patient unmet need. This role also has substantial responsible for defining Late Stage Rare Disease Development approaches for licensing/Business Development activities. The successful candidate will have membership in the Immunology Development Leadership Team.  

Primary Responsibilities

  • Deliver innovative, fit-for-purpose and transformational development strategies that address high unmet needs for all Immunology Rare Disease assets in late phase clinical development.   Support development programs to ensure they meet the needs of patients, Regulators and Commercial stakeholders.
  • Accountable for delivery of regulatory submissions, including oversight of the preparation of clinical portions of Agency licensing applications and other regulatory submissions.
  • Collaborate with Disease Area Strongholds (DASs), Pathway Strongholds (PASs), Discovery, Clinical Pharmacology, Medical Affairs and Commercial, and Business Development to deliver all late stage Rare Disease development matters and identify external opportunities and platforms required for next generation Immunology products.
  • Is an integral/core member of the Immunology Development organization through membership on the Development leader team (DLT) and will contribute leadership and innovation with a “one portfolio high performing team” mindset as well as instill a culture of collaboration and rigor based on cutting edge methods and practices.
  • Contributes to Immunology Development functional organization as a member of the Development Leadership team managing the Rare Disease Development talent strategy, driving operational excellence and efficiency, and drive key innovation initiatives

General Leadership Expectations

  • Effective collaboration and implementation of core Immunology TA strategies with a one-team, one-portfolio mindset
  • Strong capacity to work in a matrix environment and lead through ambiguity
  • Outstanding visionary, strategic, communication and entrepreneurial skills
  • Develop and maintain a strong external network including credible relationships with scientific leaders, key clinical opinion leaders, and regulatory officials as needed to advance the Immunology portfolio.
  • Develop and maintain strong internal network with cross-functional groups required to operationalize and drive portfolio progression
  • Represent both Janssen and the Immunology TA in a professional manner internally and externally

Kualifikasi

Professional Experience and Requirements

  • MD, or MD/PhD is ideal. Rare Disease expertise.  Late stage development experience is essential.
  • At least 10 years of relevant experience in drug development or equivalent
  • Candidates should possess significant experience in clinical application of approaches to the treatment of immune diseases and a strong passion to drive programs into diverse indications, based on scientific rationale and unmet medical needs
  • Broad understanding of drug development is critical with ability to drive innovation in drug development and ability to supervise, implement, and maintain high standards of research conduct
  • Exceptional communication skills and leadership experience in drug discovery and/or early development to communicate goals and deliverables to senior management and governance committees through J&J

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

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