Director, Dermatology Clinical Development, Immunology

Company: Disability Solutions
Location: Spring House
Posted on: March 20, 2023

Job Description:

Janssen Research and Development, L.L.C., a member of Johnson and Johnson's Family of Companies, is recruiting for a Director, Dermatology Clinical Development, Immunology , 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. POSITION OVERVIEW Janssen Immunology applies actionable scientific insights to unmet medical needs, to deliver transformational and accessible therapies that restore immune balance, health, and remission for patients with Immune-Mediated Inflammatory Disease (IMID). The Director, Clinical Development is part of the Development Physician team at Janssen Immunology, providing clinical development and medical / scientific leadership for Phase 2 and 3 programs, and applicable disease area expertise [including Dermatology] for the Therapeutic Area (TA). The Director, Clinical Development is a leading member of cross-functional teams focused on the creation and execution of integrated clinical development plans which seek to produce transformational and accessible therapies for patients with immune-mediated inflammatory disease. The role involves close partnership with project clinical scientists and extensive collaboration with colleagues across disciplines, including discovery, translational science & medicine, clinical pharmacology, biostatistics, data science, medical writing, clinical operations, medical safety, regulatory affairs, quality, medical affairs, commercial and market access. Beyond individual internal drug development programs, the Director, Clinical Development also contributes to innovation initiatives in disease / pathway areas, drug development processes, and external partnering / business development. The successful candidate will have strong clinical development, matrix leadership, and communications skills, with a high degree of curiosity, flexibility, innovation, entrepreneurship, and drive to address unmet medical needs for patients. Primary Responsibilities

• Medical / scientific leadership of Phase 2 and 3 clinical trials / programs, including:
  • Design: concepts, project plans, protocols, case report forms, operational & analytic plans
  • Execution: regulatory / ethics committee applications, start-up, enrolment, medical monitoring, lock, close-out activities
  • Analysis: interpretation of clinical and scientific data
  • Reporting: internal communications, external scientific disclosure, regulatory filings (including marketing applications and associated activities)
  • Medical / scientific leadership for compound-level right-to-operate elements, including Investigator Brochures, Safety Update Reports, Risk Management Plans, & product labelling
  • Medical / scientific leadership in interactions with internal cross-functional partners and senior leaders, external medical / scientific investigators / experts / leaders, & health authorities
  • In collaboration with Compound Development and Disease / Pathway Area Stronghold teams, development / execution of:
    • Disease / pathway area strategies including indication / target prioritization, future treatment paradigms incorporating treatment sequences & combinations, precision medicine / patient stratification
    • Novel outcome measures for inclusion in clinical trials / practice / labelling
    • Medical / scientific leadership in business development activities, including assessment / due diligence for external program / asset partnering opportunities
    • Participate in cross-departmental / cross-functional projects with broad Janssen impact General Expectations
      • Strong passion to drive programs into diverse indications, based on scientific rationale and unmet medical needs
      • High degree of curiosity, creativity, learning and change agility
      • Looks beyond information to anticipate, develop, and convey implications, options, recommendations
      • Strong communication and entrepreneurial skills
      • Ability to build and foster collaborative relationships
      • Strong capacity to work, lead, and influence in a matrix environment
      • Can represent Janssen and the Immunology TA with professionalism and integrity both internally and externally
      • Strong capacity to work, collaborate, communicate, influence, and lead in a cross-functional matrix environment, delivering Immunology TA strategies with a one-team, one-portfolio mindset
      • Broad understanding of clinical research / drug development with ability to drive innovation and maintain high standards of research conduct
      • Develop and maintain an external network including credible relationships with scientific leaders, key clinical opinion leaders, and regulatory officials as needed to advance the Immunology portfolio
      • Represent Janssen Immunology in a highly professional manner internally and externally

Keywords: Disability Solutions, Philadelphia , Director, Dermatology Clinical Development, Immunology, Healthcare , Spring House, Pennsylvania