Principle Clinical Research Scientist (EMEA)
Location: Livingstone (Scotland) Or Leeds (UK) Or Germany.
Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science — bringing creative ideas, products and services to advance the health and well-being of people. We touch the lives of over a billion people every single day.
Are You Ready To Impact The World?
If you want to leave your mark and be valued for who you are, Johnson & Johnson offers an outstanding experience to professionals looking for an opportunity to work with hardworking people who share your real passion for caring in an environment that empowers you to drive your own career.
Ethicon: we are passionate about leading advancements in surgical technologies and solutions to address unmet healthcare needs. From creating the first sutures, to revolutionizing surgery with minimally-invasive procedures, Ethicon has made significant contributions in medical device technology to transform the way surgery has been done for more than 60 years.
The Medical Device Group has an exciting opportunity for a Principle Clinical Research Scientist (EMEA) to serve as the clinical franchise representative for planned studies for EMEA sites. This is an R&D manager role working in a Clinical Research group that designs clinical research studies. There are no direct reports with this position.
We seek an accomplished individual to be responsible for Clinical R&D activities for assigned projects, utilising their scientific expertise and insights to provide input into evidence generation and dissemination strategies (EGS / EDS). The Principle Clinical Research Scientist reports into the Franchise Platform Leader or Senior Clinical Research Manager.
Overall Responsibilities:
- Develops and delivers Global evidence generation and dissemination strategies (EGS / EDS) to support New Product Development (NPD) and Life-Cycle Management (LCM) projects within the assigned platforms, working in partnership with all relevant clinical research and development partners and cross-functional partners (e.g. Global Strategic Marketing, Medical Affairs, Regulatory Affairs, Health Economics & Market Access, R&D, etc);
- Positively partners and engages with the Clinical Operations and Biostats teams on assigned clinical projects, to ensure project commitments are delivered on time, within budget and in compliance with regulations and Standard Operating Procedures (SOP);
- Orchestrates input, engagement and alignment from key regional Medical Devices CR&D leads and other strategically important countries/regions in the development of the EGS;
- Leads in study design to develop appropriate clinical trial protocols to meet the project needs;
- Leads in appropriate interpretation and dissemination of all evidence generated, including Clinical Study Reports, abstracts, manuscripts, Clinical Evaluation Reports etc
- Contributes in clinical scientific discussions with regulatory agencies / notified bodies to drive support of the clinical and regulatory strategy, including proposed clinical investigations; review process of clinical evidence generated for marketing authorization, line extensions, etc, including during sponsor regulatory inspections;
- Drives team’s collaboration with key opinion leaders, investigators, IRB’s/EC’s, Regulatory Agencies, societies, associations, etc;
- Cultivates positive relationships with external stakeholders to shape and influence relevant policies
- Partners with internal stakeholders to ensure accurate dissemination of clinical data/evidence in value briefs and technical summaries for market access and reimbursement
Functional And Technical Proficiencies:
To be a success in role, the competencies we seek are:
- Detailed understanding of clinical research science and processes along with a broad and extensive understanding of product development processes, team dynamics, related healthcare market environment, clinical trends, and global clinical trial regulations;
- Ability to provide strategic and scientific clinical research input across NPD and LCM projects, including complex and / or transformational projects;
- Proven record in delivering clinical programs within clinical / surgical research setting, on time, within budget and in compliance to SOPs and regulations;
- Detailed understanding of clinical trial regulations across multiple regions;
- Ability to lead teams – to influence, shape and lead without direct reporting authority – to deliver critical landmarks and complex projects;
- Ability to collaborate across different functional areas within CR&D to ensure alignment with governance processes (assigning roles and responsibilities, setting priorities) to meet business objectives;
- Proven ability to build collaborations with partners;
- Change agent in team development and progression;
- Experience in effective management of project budget processes
Qualifications
Education & Experience Requirements:
- A Bachelor’s degree in Biological Science or related subject area!
- 8 years related scientific / technical experience (or equivalent level of experience)
- Medical device experience a plus, or progressive experience within CRO / pharma experience is also welcome
- Clinical Research management, project management, involvement in strategy development and leadership skills
