Johnson & Johnson
Clinical Project Physician
Location: Allschwil - Switzerland
Category Clinical Research MD
The Clinical Project Physician (CPP) is an integral member of the Clinical Sciences (CS) team.
The CPP will be responsible for providing the medical input and medical oversight for the development and execution of clinical study/-ies within the Pulmonary Hypertension (PH) therapeutic area.
The successful candidate will work closely with leadership in informing, influencing and implementing strategies for all aspects of clinical development.
The CPP will execute Clinical Development Plan (CDP), study deliverables (e.g. study protocols, regulatory submissions, updates to Investigator Brochures, clinical study reports, etc.), provide expert clinical input, and review of the study, label, SUSARs data as well as lead publication of documents required.
The CPP will act as Study Responsible Physician (SRP) of one or more clinical studies. The CPP will collaborate with the Study Responsible Scientist (SRS) of the assigned study to ensure proper conduct of various clinical studies. This role involves extensive team matrix interactions with colleagues from different disciplines such as Clinical Operations, Drug Safety, Biostatistics, Data Management, etc.
· Contributes to and is key member of clinical study team.
· Conducts medical data review of trial data, including eligibility review.
· Responsible for site interactions in partnership with the SRS for medical questions and education (including safety management guidelines).
· Responsible for assessment of key safety-related serious adverse events in partnership with the Local Safety Officer and the Medical Safety Officer and oversees safety narratives.
· Collaborates with the SRS and inputs into protocols, providing medical strategic oversight in protocol development (input on inclusion/exclusion criteria and other safety-related clinical considerations).
· Fulfills GCP and compliance obligations for study conduct and maintains required training.
· Ensure that the medical care given to, and medical decisions made on behalf of, patients should always be the responsibility of a qualified healthcare provider.
Clinical studies expertise & strategy:
· In collaboration with the leadership and other cross-functional team members, executes CDP, designs and develops clinical plans and protocols with a strong strategic focus based on knowledge of the asset/drug, disease area, and relevant science to meet regulatory and disease strategy targets.
· May lead study Steering Committees (together with Clinical Leader),
· May contribute to IDMC (selection of members, drafting of charter, etc.)
· Leads the analysis of benefit/risk for clinical study protocols in a matrix team environment working in partnership with SRS.
· Partners with CS to support executional delivery of studies (e.g., site activation, enrollment status, as well as adjudication for protocol violations, significant, non-significant deviations, etc.).
· Builds relationships with Investigators and supports study site selection. Partners with key opinion leaders (KOLs) to gain their input on emerging science in drug and biomarker research, disease knowledge, and design of clinical studies and programs.
· Maintains a strong medical/scientific reputation within the disease area. Has in depth knowledge of etiology, natural history, diagnosis, and treatment of the disorder. Keeps up to date in the disease area via attendance at scientific conferences and ongoing review of the literature.
· Stays knowledgeable of development and regulatory issues related to other competitive or relevant compounds in development and how our portfolio fits into the competitive landscape.
· Provides ongoing medical education in partnership with CS, protocol specific training, to support study team, investigators, and others.
· A Medical Degree (MD) is required.
· A minimum of 5 years of industry and prior experience with clinical development/clinical studies is preferred but not a must.
· Clinical experience in cardiology or pulmonology area is highly preferred.
· Prior experience as study responsible physician and managing projects with clinical trials including development of protocols, case report forms, informed consent, study initiation, protocol training, and clinical data monitoring is preferred.
· Excellent written communication, oral communication, and presentation skills are required.
· The individual must have demonstrated ability to work and lead in a cross-functional and matrix team environment, working with external stakeholders and be flexible and adaptable.