Johnson & Johnson Careers
Manager, Clinical Research
Requisition ID: 3982181029
Mentor Worldwide L.L.C., a
member of the Johnson & Johnson family of companies, is recruiting for a
Manager, Clinical Research located in Irvine, CA.
Mentor Worldwide LLC, part of Johnson & Johnson Medical Devices Companies, is a leading supplier of breast implants in the global aesthetic market. The company develops, manufactures, and markets innovative, science-based products for surgical and non-surgical medical procedures that allow breast surgery patients to improve their quality of life. The company is focused on two strategic areas: breast reconstruction and breast augmentation. MENTOR is the only manufacturer whose silicone breast implants are made in the U.S.A. For more information, visit www.mentorwwllc.com
On behalf of the Medical Device Group, you the Manager, Clinical Research will lead the development of clinical evidence generation and dissemination strategies (EGS/EDS) across assigned New Product Development and Life-Cycle Management (NPD / LCM) projects for Mentor Worldwide LLC.
- Responsible for Clinical R&D activities for assigned projects, including:
- Develop and deliver appropriate Global EGS / EDSto support NPD /LCM within the assigned platforms, with collaborative relationships with all relevant CR&D partners and cross-functional partners (e.g. Global Strategic Marketing, Medical Affairs, Regulatory Affairs, HEMA, R&D, etc), ensuring cross- functional alignment;
- Responsible for delivery of assigned clinical programs, through effective partnership with the Clinical Operations and BSDM teams, to enable optimized engagement leading to delivery of clinical project commitments (delivery on time, within budget and in compliance with regulations and SOP);
- Ensure input and strong alignment from key regional MD CR&D leads and other strategically important countries/regions in the development of the EGS / EDS;
- Lead team of clinical research scientists to design appropriate clinical trials to meet the NPD / LCM needs;
- Lead teams to ensure appropriate interpretation and dissemination of all evidence generated, based on EDS, including CSRs, CERs, abstracts, manuscripts, etc
- Contribute 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;
- Responsible for team’s interface and collaboration with key opinion leaders, investigators, IRB’s/EC’s, Regulatory Agencies, societies, associations, etc;
- Foster strong relationships with external stakeholders to shape and influence relevant policies, etc
- Partner with internal stakeholders to ensure accurate dissemination of clinical data/evidence in value briefs and technical summaries for market access and reimbursement
- Manages work independently; may provide solutions to complex situations.
- Performs other duties as assigned.
- A PhD or equivalent degree in Biological Science or related discipline is required.
- A minimum of 8 years related scientific / technical / clinical research experience is required.
- A minimum of 1 year project management/leadership experience within clinical research is required.
- A minimum of 1 year people management experience is required.
- Thorough understanding of clinical research science and processes along with a good understanding of product development processes, team dynamics, related healthcare market environment, clinical trends, and global clinical trial regulations
- Ability to manage scientists to provide strategic and scientific clinical research input across NPD and LCM projects
- Proven track record in delivering clinical programs within clinical / surgical research setting, on time, within budget and in compliance to SOPs and regulations;
- Ability to lead teams to deliver critical milestones;
- Ability to collaborate across different functional areas within CR&D to ensure alignment with governance processes (assigning roles and responsibilities, setting priorities, managing deliverables, etc). and to meet business objectives;
- Demonstrated ability to build collaborative relationships with key internal and external partners and stakeholders;
- Ability to influence, shape and lead without direct reporting authority;
- Change agent in team development and progression;
- Experience in effective management of project budget processes
- Through transparent leadership, be a key leader in developing a high-performing team with a global culture;
- This position requires full time hours in our Mentor office in Irvine, CA, and may require up to 30% travel in the US and Internationally.
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