Director, Clinical Scientist – Immunology

J&J Family of Companies
Published
July 30, 2022
Location
North Wales, PA
Category
Job Type

Description

Janssen Research and Development, L.L.C., a member of Johnson and Johnson's Family of Companies, is recruiting for a Director, Clinical Scientist, 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 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 (https://www.jnj.com/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:

The focus of the Director Clinical Scientist is to support various clinical research tasks associated with assigned Immunology Development clinical trials, providing leadership in program execution, innovation, and optimization of execution. Scope of work will include responsibilities associated with the conduct, monitoring, and reporting results of clinical trials evaluating therapeutics in immuno-inflammatory disorders. The range of responsibilities may vary to some degree depending on the disease area and trial-specific requirements.

The Director Clinical Scientist is a key member of a clinical team dedicated to the development and execution of clinical strategies and the clinical and operational implementation of a complex compound program. The Director Clinical Scientist provides active scientific contribution to a cross-functional clinical team developing a molecular entity. Director Clinical Scientist will collaborate with Project Physician(s) in monitoring/leading of one or more clinical trial conduct and additionally may perform other duties. Director Clinical Scientist provides input to the clinical development plan, works on the development of the clinical trial protocol, clinical trial materials, and takes responsibility for coordinating completion of clinical study reports and supports preparation of relevant documents for regulatory filings. This role involves extensive team matrix interactions with colleagues from different disciplines. Director Clinical Scientist may be asked to contribute to the evaluation of scientific opportunities in the therapeutic area.

Responsibilities include:

  • Provides clinical development expertise through the entire clinical trial process

  • Performs activities which support the design, execution, monitoring, and reporting of clinical trials.

  • Leads preparation of clinical development plans, trial protocols, case report forms, study operational plans

  • Performs medical monitoring and reporting in partnership with Study Responsible Physician, evaluates clinical trial adverse events, reviews clinical laboratory results, drafts adverse event narratives.

  • Builds credible relationships with clinical investigators, medical/scientific experts

  • Partners with Clinical Operations in trial set up, conduct, recruitment activities, closeout, and reporting

  • Assists Data Management with the review of clinical data and query resolution

  • Works closely with Quality Management & Assurance to ensure flawless execution of clinical trials

  • Drafts and coordinates completion of clinical study reports

  • Drafts responses to questions from Ethics Committees and Health Authorities

  • Supports integrated document development for marketing authorization filing

  • Interprets, reports and prepares oral and written results of product research, in concert with senior clinical personnel, in preparation for health authority submissions

  • Supports preparation for the FDA Advisory Committee and EU Oral Explanation

  • Reviews medical literature and related new technologies

Qualifications

Qualifications:

  • BS, MS, PharmD, PhD or RN preferably with a scientific background in Immunology or a related field, and 10 years industry experience or equivalent clinical research experience is required.

  • Experience in late-stage drug development, experience in immuno-inflammatory indications is preferred.

  • Ability to survey and interpret the scientific literature related to the assigned projects is required.

  • Strong organizational skills and the ability to work well in a dynamic environment and be able to prioritize and respond to changing needs of the business.

  • Good interpersonal skills and the ability to advise, persuade, and negotiate with colleagues in a supportive and encouraging fashion.

  • Excellent written and verbal English communication skills.

  • The ability to work in a global matrix organization with cross-functional teams is required.

  • Proficient with Microsoft Office applications EXCEL, POWERPOINT, and WORD.

  • 10-20% domestic/international travel may be required.

    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.

    ImpactImm

Primary Location

United States-Pennsylvania-Spring House-Welsh & McKean Roads

Organization

Janssen Research & Development, LLC (6084)

Job Function

R&D

Requisition ID

2206037900W

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