J&J Family of Companies Oncology TA Clinical Study Responsible Physician in Leiden, Netherlands
‘Caring for the world, one person at a time’... inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people.
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.
Janssen Pharmaceutica joined the Johnson & Johnson group in 1961. Today, Janssen Pharmaceutica is one of the most innovative pharmaceutical companies in the world. Our research and development centre develops products for a wide range of disease areas, such as mental disorders, neurological problems, infectious diseases, immunological disorders, cancer, and cardiovascular and metabolic conditions.
The Study Responsible Physician will contribute to the development and oversee the execution of oncology clinical research studies, ensuring consistency and quality, across the assigned development program. In this role, the Study Responsible Physician will provide mentoring and support to the clinical project scientists on the team and will work with PMO, Finance, and the Clinical Leader to assure appropriate resourcing of clinical studies. The Study Responsible Physician will work closely with the clinical project scientist team and Clinical Leader in Late Development, in collaboration with other functional disciplines, including GCO, Data Management, Statistics, Regulatory, QMMC, and GMS to ensure flawless and integrated execution of study start-up planning, oversight, and reporting of clinical studies in Oncology. Together with the Clinical Leader, the Study Responsible Physician will represent the clinical team in governance and committee meetings relating to the overall strategy and operational implementation of the clinical studies in the development plan.
Lead the project scientists, ensuring appropriate training, mentoring, and supervision across the assigned study/studies within the clinical development program
Work closely with functional partners (Data Management, Biostatistics, Regulatory, GCO, QMMC, GMS) to ensure an integrated and strategic approach to flawless execution and systematic oversight of study protocol(s) in late development in close collaboration with key functional stakeholders
Provide support for clinical study/studies within a development program including:
Working closely with the colleague study responsible physicians and clinical project scientists in collaboration with GCO and GMS to ensure comprehensive medical monitoring, thorough and timely responses to address site issues and eligibility questions, and detailed, real time review of serious adverse events and deaths
Working in partnership with colleague study responsible physicians and clinical project scientists to ensure development of high quality study protocols including use of consistent processes/standards across studies
Collaborate with the Clinical Leader, Clinical Project Scientists and Procurement on key study design elements including assessment of complexity and cost of protocol-required evaluations
Participate in strategic study start-up planning in collaboration with GCO, C&G, and RTAEs including early site assessment, feasibility, and use of simplified contract and budget templates to accelerate rate of site activations
Co-lead and oversee clinical development/authorship of informed consent forms, eCRFs, study manuals, clinical study reports, and regulatory submission documents
Work closely with Medical Writing to support protocol or protocol amendment completion
Work closely with Clinical Leader, Project Physician, Regulatory and GCO to address protocol questions from Health Authorities and Ethics Committees in a consistent fashion
Work closely with GCO to track study recruitment, and implement action plans to address early impediments to study enrollment
Work closely with Quality Management & Quality Assurance to review audit findings and implement effective corrective action plans
Work closely with clinical scientists and data management to support medical review and data query resolution
Interact with clinical investigators and Key Opinion Leaders as appropriate
Work with GCO to provide oversight of CRO/study vendors’ performance as it relates to study start-up and conduct
Work with the Clinical Leader, with Data Management and with Statistics on analysis of study results and completion of study reports
Work with the Clinical Leader to support the development and compilation of NDA/MAAs and to support responses to Health Agency questions and HA presentations post-filing
May review/co-author medical publications emerging from clinical trial results
This is not an exhaustive, comprehensive listing of job functions. May perform other duties as assigned.
Contacts Inside the Company:
Members of the Clinical and Compound Development Teams
Therapeutic Area VPs of Clinical Research
Contacts Outside the Company:
May act as a liaison between company and clinical investigators, vendor managers, and CROs
May be asked to assess and plan for external clinical research opportunities in collaboration with Clinical Leader and BD
May interact with medical consultants in concert with senior clinical staff, in conducting IDMC and Investigator meetings as well as Advisory Boards
Reports to the Clinical Leader of a late stage development program
Leads the clinical project scientist members of study team(s), providing effective direction, supervision, and mentoring
Education and Experience:
Minimum of an MD’s degree; advanced degree (PhD) is a plus
Minimum of 2+ years of oncology clinical research experience in late clinical development within pharmaceutical industry or equivalent experience in academic or large regional hospital
Required Technical Knowledge and Skills:
Fluent in written and spoken English with excellent communication skills
Working knowledge of the use of Microsoft suite of software products including Excel and Word
Knowledge of Good Clinical Practices and regulatory requirements for the conduct of high quality oncology clinical trials
Experience in protocol development, medical review, oversight of study conduct, data quality and safety is considered a plus.
What’s in it for you…?
“Caring for the world, one person at a time…”
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.
Europe/Middle East/Africa-United Kingdom-England-High Wycombe, North America-United States-Pennsylvania-Spring House, Europe/Middle East/Africa-Netherlands-South Holland-Leiden, North America-United States-California-Los Angeles, North America-United States-New Jersey-Raritan
Janssen Pharmaceutica N.V. (7555)
Clinical Research MD