Johnson & Johnson Careers
Director, Clinical and Medical Operations
Clinical Research non-MD
Requisition ID: 4313181011
Johnson & Johnson, through its operating companies, is the world's most comprehensive and broadly-based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical, and medical devices and diagnostics markets. We strive to provide scientifically sound, high quality products and services to help heal, cure disease and improve the quality of life.
Johnson & Johnson Medical Companies (JJMDC), a division of Johnson & Johnson Inc., markets and distributes medical device and diagnostic solutions for use in institutional and primary health care settings across Canada. JJMDC focuses on providing minimally invasive treatment options spanning various medical procedures and disease states. Among the products represented by its various business units are: surgical instruments, orthopaedic implants, devices for women’s health including breast care, infection prevention and general-purpose sterilizers, hernia solutions, haemostatic products, cardiovascular and neurovascular diagnostics and treatment.
The Director will be responsible for the development of overall Clinical and Medical strategies at Johnson & Johnson Medical Companies (JJMC) Canada.
In consultation with senior leadership, you will determine the focus and direction of the team. You will oversee the Associates within the team and lead all Human Resources functions related to Clinical Operations & Medical Operations.
You will work with the business franchises to ensure alignment, with source to ensure collaboration, and with key academic centers on innovation.
You will be responsible for the development and growth of strategic relationships with global operating companies, key opinion leaders, and research investigators and will also lead and execute local clinical studies.
Develop clinical strategies based on strong scientific rationale for pre-launch and marketed products within JJMC and implement these through comprehensive medical and clinical plans integrated with the business plans to support launches and commercial success of the product.
Establish standards for all Clinical/Medical Operations activities in Data Generation, Data Communication and KOL interactions, including Sponsored Trials, Supported Trials, and Registries. Ensure overall quality and work performed by Clinical Affairs Managers and Associates is maintained at a high standard and according to the ICH-GCP.
Develop/update SOP’s and related training materials.
Provide overall Clinical/Medical oversight and ensure local copy review and medical information requests as well as review medical communications.
Lead Canadian Investigator Initiated Study requests from application through to study completion.
Liaise with regional and global franchises, and internal departments to communicate local/regional research needs, activities and study updates, and contribute to global alignment of clinical research activities.
Understand and remain current with clinical, scientific, and regulatory developments relevant to JJMC products and companies and ensure regional needs are addressed in the development of clinical strategies, plans and protocol study designs.
University Degree. Bachelor of Science with a preference to an advanced degree in Health Sciences. MS, PhD or MD.
Experienced in all aspects of Clinical Research, both company sponsored and Investigator Initiated
Experience in study design, site initiation activities, and site monitoring
Minimum 3-5 years’ people management experience
Knowledge of data management and statistical analysis
Sound knowledge of ICH GCP and Health Canada Regulations
Sound knowledge of copy review and medical information request requirements
Strong presentation and facilitation skills
Proven good verbal and written communication that is timely, clear and effective
Demonstrated ability to maintain a constructive problem-solving attitude while dealing with time demands and unexpected events
Highly motivated, detail orientated
Demonstrates effective time management skills
Strong customer service and relationship management skills
Experience with trial audits
Health Outcomes research experience
Bilingualism (English and French) and asset
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
Johnson & Johnson Inc. (7695)
Clinical Research non-MD