J&J Family of Companies Medical Leader, ARDS in United States
Janssen R&D is currently recruiting for a Medical Leader, ARDS to be located at any major Janssen R&D site in the US or EMEA
Caring for the world, one person at a time, inspires and unites Johnson & Johnson. J&J embraces research and science – bringing innovative ideas, products and services to advance health and well-being. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world. J&J has more than 250 companies located in 60 countries around the world.
Who is Janssen?
We’re more than 30,000 people working hard to prevent, treat, cure and stop some of the most devastating and complex diseases of our time. From heart disease to HIV, Alzheimer’s disease to cancer, we are committed to issues that touch everyone’s lives.
Our Mission and Vision:
Our mission is to transform individual lives and fundamentally change the way diseases are managed, interpreted, and prevented. We believe that challenging something is the best way to change it. So, every day, in more than 150 countries, we bring cutting-edge science and the most creative minds in the industry together to think differently about diseases. We aim not only to innovate, but also to empower people with the tools they need to make informed decisions and achieve the best possible results for their health.
We are looking at a future where the world of healthcare will be challenged by informed and empowered patients. We work for change that will improve access to medicines: the best available treatment at an affordable price. That’s why we at Janssen strive to provide access to effective and affordable medicines and related healthcare services to the people who need them.
I. Member of the Compound Development Team
Give input / feedback on the Overall Development Plan in alignment with therapeutic area strategy and compound strategy. Works closely with CTDL and co-leads the development and maintenance of the Clinical strategic plan in line with the Company Planning Tool as well as the Clinical project plans (activities, resource requirements, budget and timelines) for the compound and related functions in concert with project management and CTDL
Represents the Clinical team at the CDT and participates in the strategic decision making of the CDT.
Manages cross-functional execution of the overall clinical development plan according to quality standards and agreed upon timing
Responsible for clinical component in Compound Strategy document, Project essentials,Target Label and other company documents
Responsible for clinical component in regulatory documents (IND, CTD, …)
II. Chair of the Clinical Team
Co-Initiator and co-moderator (together with CPML) of the clinical meetings, collecting agenda points, ensure sending out agenda for the meeting, and assure minutes are made of the meeting and posted in the electronic exchange
Works closely with CPML and co-leads the development and maintenance of the Clinical strategic plan in line with the Company Planning Tool as well as the Clinical project plans (activities, resource requirements, budget and timelines) for the compound and related functions in concert with project management and CDT.
Give input / feedback on the Clinical Development Plan, the Overall Clinical Resource Plan (budgets and FTEs), Overall Medication Plan (clinical project medication needs), Overall Quality Monitoring Plan, Overall Adverse Event Review Plan and Project Essentials & Regulatory Summary Documents
Owner of the following clinical documents: Clinical Strategic Plan/Clinical Development Plan, Clinical Trial Protocol, Clinical Research Report, Clinical Modules of the Common Technical Document
III. Clinical Project supervision
With the CPML as his/her right hand, supervise the evolution of the different trials:
Ensure projects/trials are running as planned
Ensure projects/trials progress with the required quality
Answering compound related medical questions
Continued clinical safety assessment of the compound:
Coordinate answers to questions of Regulatory Authorities, IECs/IRBs and Investigators.
Evaluate if new safety information requires an Amendment to the Clinical Trial Protoco(s)l and/or Informed Consent (IC) Form for on-going Clinical Trials. If so instruct the CPML to initiate the development of Protocol Amendment(s) and/or updated IC Form(s).
Ensure that, if applicable, follow-up information on a SAE is collected.
ADR review and adjudication
Input in safety documents (PADER, ASR, PSUR, RMP)
Member of the Safety Management Team
Clinical trial set-up activities:
Prepare and approve the Protocol Elements Document.
Review and approve the Clinical Trial Protocol within the specified timelines.
Decides with the CDTL, where trial(s) will be performed
Review the trial specific Master Informed Consent Form within the specified timelines. Medical Leader is the owner of the “Risk – Benefit” section of the ICF
Review the Statistical Analysis plan (SAP) within the specified timelines.
Review and approve the Data Safety Monitoring Board (DSMB) protocol or charter.
Oversight of clinical trial coordination activities when not acting as trial physician for particular trials.
Managing clinical trial coordination activities when acting as trial physician for particular trials:
Performing medical review and safety analysis of clinical trial subjects
Review and approval of all the required listings prior to database lock
Inform the Global Trial Manager (GTM) of a change in scope, timelines, budget and quality influencing any of the trial coordination activities.
Perform other trial physician activities as applicable.
Managing Post-trial activities (or activities related to an upcoming analysis)
Supervision of the data analysis and report writing
Preparation of the safety part of Top Line Results presentation
Review and approval of the Clinical Research Report
Presentation of trial results
IV. Interaction with regulatory agencies
Is key liaison to regulatory agencies
Member of the labeling working group
Clinical part of regulatory documents (IND, CTD, …)
IV. Interaction with the medical community
Is key liaison with medical affairs, strategic marketing, external opinion leaders and Advisory Boards
publication of data and presentation at conferences
V. Contribute to the development and improvement of departmental procedures and processes
Contribute to the development and improvement of departmental procedures and processes and template in the scope of the company’s efforts towards continuous quality improvement.
Leadership in clinical development requires a recognized expert with detailed understanding of the pathophysiology underlying respiratory disease, a strong foundation in drug development, along with a deep understanding of the disease area, and an aptitude for building an extensive network of KOLs and scientific leaders.
A minimum of an MD or MD/PhD, with specialty in internal medicine and/or respiratory diseases and/or ICU experience is required
A minimum of 10 years of industry or academic experience in these areas. Individuals with clinical expertise in respiratory viral infections, bacterial infections, ARDS, and sepsis will be preferred
Strong record of accomplishments in disease specific clinical research and clinical development as evidenced by peer-reviewed publications, leadership in scientific organizations, successful record of drug development for respiratory, or infectious diseases.
Demonstrated accomplishments in drug development (small molecules or biologics as direct anti-pathogen approaches or indirect immunomodulation approaches). Experience in clinical documentation in regulatory dossiers is an additional asset. A well-funded research track record would be attractive. A track record of successful Clinical Development program leading to drug registration would be attractive.
Collaboration and Teaming – able to drive discussions using a data driven and objective approach; works well across functions and groups; able to build and inspire teams effectively; instills a global mindset; champions highest standards for clinical and scientific conduct.
Demonstrated history of driving and managing effective scientific collaboration across multiple functions, building and leading productive research teams in a matrix environment.
Highly motivated individual with well-developed leadership skills who can motivate and retain high quality individuals while inspiring hyper achievement throughout the organization.
Strong interpersonal skills is a must, with proven ability to communicate with other members of the executive management team, external thought-leaders, and other stakeholders.
United States-New Jersey-Titusville-1125 Trenton Harbourton Road
North America-United States-New Jersey-Raritan, North America-United States-California-La Jolla, Europe/Middle East/Africa, North America-United States-Pennsylvania-Spring House, North America-United States-California-San Francisco
Janssen Research & Development, LLC (6084)
J&J Family of Companies
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