- Spring House, PA
Janssen Vaccines & Prevention B.V., previously Crucell, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, is dedicated to bringing meaningful innovation to global health. Our teams focus on the discovery, development, manufacture and marketing of vaccines and antibodies to protect people worldwide from infectious diseases.
In our organization entrepreneurial people are working in a dynamic culture in which innovation and a 'can do' state of mind are the central points. In order to strengthen our team we are continuously looking for enthusiastic, talented people who have the ambition to develop themselves and can be of value to Janssen.
Member of the Compound Development Team
- Give input / feedback on the Overall Clinical Development Plan in alignment with therapeutic area strategy and compound strategy. The Compound Development Team owns and maintains the new product Development Compound Strategy documents
- Manages cross-functional execution of the overall development plan
- Maintains ongoing compound strategy throughout compound life cycle
Member of Clinical Team
- Initiator and moderator of the clinical meetings, collecting agenda points, sending out agenda for the meeting, co-moderator of the meeting and assure minutes are made of the meeting and posted in the electronic exchange folder (e.g: e-Room)
- 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
Clinical Project supervision
- With the Clinical Development Leader (CDL) 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
Planning clinical trial set-up activities:
- Prepare and approve the Trial Identification Form (TIF).
- Review and approve the Clinical Trial Protocol within the specified timelines.
- Decides with the CDL, where trial(s) will be perform
- Review the 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.
Managing clinical trial coordination activities:
- 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.
Managing Serious Adverse Event reporting process:
- Review SAE Reports to verify the content and the expedited reporting timelines set by the DSO.
- Review the draft CIOMS-I Form.
- Coordinate answers to questions of Regulatory Authorities, IECs/IRBs and Investigators.
- Evaluate if new safety information requires an Amendment to the Clinical Trial Protocol and/or Informed Consent (IC) Form for on-going Clinical Trials. If so instruct the CDL to initiate the development of Protocol Amendment(s) and/or updated IC Form(s) in documentum.
- Ensure that, if applicable, follow-up information on the SAE is collected.
Interaction with the medical community
- Ensure timely interaction with the clinicians, advocacy groups and other experts
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.
Required Certifications/Regular Training
- Company SOP relevant to the job
Tasks/Activities to be Qualified or trained for (e.g. tasks, qualification)
Key Responsibilities (provided the required staff is available such as TPs, otherwise prioritization may be needed)
- Represents the Clinical team at the CDT/eCDT and participates in the strategic decision making of the CDT/eCDT. Responsible for the overall clinical development process as well as the overall quality and timely delivery of his/her projects. Drives his/her projects through clinical development
- Works closely with CDL 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 CDL
- Is a member of the Medical Surveillance Team (depending on marketing authorization status of the compound)
- Builds and leads the clinical team
- Leads study design (trial information form), protocol writing, and medical aspects of study conduct
- Interprets clinical safety and efficacy data
- Takes ownership on the continued clinical safety assessment of the compound. Supervises the execution of protocol, data analysis, and report writing
- Provides general clinical franchise input relevant to team and expertise
- Maintains up-to-date knowledge and new scientific developments in therapeutic area
- Supports marketing activities - pre-launch, publications, conferences
- Is key liaison with medical affairs, strategic marketing, regulatory agencies, external opinion leaders and Advisory Boards
- Handles overflow from project physician activities (ref to PP R&R): study monitoring and interactions with investigators, interactions with IRBs/EC, conducting investigator meetings
Key Deliverables and Metrics of Success
- Clinical team performance against time, quality, budget, and innovation (co-leads with CDL)
- Assists CDTL with alignment of clinical development strategy with CDT/eCDT, the Company planning tool (e.g: TiboPlan) and Project essentials
- Responsible for clinical component in Compound Strategy document, Project essentials and Tiboplan, Target Label
- Timely delivery of regulatory documents (IND, CTD, ...) and high quality interactions with health authorities
- Timely delivery of safety documents (PADER, ASR, PSUR, RMP)
- Quality and completeness of clinical plan component of the Company planning tool.
- High Quality interactions with internal and external key contacts
- High quality publication of data and presentation at conferences
University degree - medical
Experience and competences:
- MD with relevant specialization or relevant industry experience in vaccines
- Demonstrated leadership and management abilities
- At least 10 years of clinical or research leadership experience, with at least 4 of those years within the pharmaceutical industry
- Significant experience in the design and conduct of phase I, II and III clinical trials
- Experience in clinical documentation in regulatory dossiers
- Pediatrics is preferred
We can also base this position in Beerse, Belgium or Spring House or Titusville in the United States.
What's in it for you ...?
As an employee, we consider you as our most valuable asset.
We take your career seriously. As part of a global team in an
innovative environment, your development is key and our day-to-day responsibility. Through e-university, on the job training, various projects and programs, we ensure your personal growth. Our benefits make sure we care for you and your family now and in the future.
United States-Florida-Titusville, United States-Pennsylvania-Spring House, Belgium-Antwerp-Beerse
Janssen Vaccines & Prevention BV (8852)
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