The Cardiovascular & Specialty Solutions (CSS) Group, part of the Medical Devices sector within Johnson & Johnson, is recruiting for a Senior Director of Clinical Research aligned to Codman Neuro located in Irvine, CA.
The CSS Group consists of six diverse businesses including Acclarent, Advanced Sterilization Products (ASP), Biosense Webster (BWI), Codman Neuro, Mentor, and Sterilmed. The CSS Group serves a diverse base of customers in Ear, Nose and Throat (ENT), Infection Prevention, Electrophysiology (EP), Neurovascular and Neurosurgery, Surgical and Non-Surgical Aesthetics, and Reprocessing.
Codman Neuro develops a wide range of diagnostic and therapeutic products for the treatment of neurovascular and neurological disorders, focusing on hydrocephalus, neuro-critical care, tumors, pain management, severe spasticity, aneurysms and cerebral arteriovenous malformations. This division focuses on minimally invasive solutions for hemorrhagic and ischemic strokes, and treatment of treatment of cerebral arteriovenous malformations. Our environment is entrepreneurial, learning-driven, and is as challenging as it is rewarding.
The Senior Director of Clinical Research will:
• Be accountable to lead a team of clinical research professionals to develop evidence generation strategies for X Platform(s)/Business Units, with Y Franchise, and, through transparent leadership, develop a high-performing team with a global culture.
• Report to the Franchise Leader, MD CR&D;
• Be accountable for all Clinical R&D activities for X Platform(s)/Business Units, including:
Serving as the CR&D representative on the platform governance / innovation committees, provide critical and technical expertise in portfolio prioritization;
• Provide critical technical and strategic expertise in the assessment of NBD projects and opportunities identified through the Innovation Centers, including potential investment and acquisition opportunities, to shape business strategy;
• Build and develop talent to provide deep strategic and scientific clinical research capability across assigned platforms;
• Lead team of clinical research professionals to develop and deliver appropriate Global Evidence Generation and Dissemination Strategies (EGS / EDS) to support New Product Development and Life-Cycle Management 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, G-HEMA/EBM, R&D, etc), ensuring cross- functional alignment;
• Be accountable for overall 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 Clinical Study Reports, abstracts, manuscripts, etc
• Lead 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;
• Be accountable 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 EBM/HEMA and Medical Affairs to ensure accurate dissemination of clinical data/evidence in value debriefs and technical summaries for market access and reimbursement
• A minimum of a Bachelor’s degree in Biological Science or related discipline, with a minimum of 10 years related scientific / technical experience, including leadership / management role within Clinical Research for at least 8 years.
• With a PhD or Masters, these requirements would be a minimum of 8 years related scientific / technical experience, with at least 6 years of management within a Clinical Research role.
• People management experience is required.
• Thorough 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 is required.
• Ability to build and lead a team of scientists to provide scientifically rigorous strategic and scientific clinical research input across NPD and LCM projects is required.
• Proven track record in delivering clinical programs within clinical / surgical research setting, on time, within budget and in compliance to SOPs and regulations is preferred.
• Comprehensive understanding of clinical trial regulations across multiple regions is required.
• Ability to lead teams to deliver critical milestones is preferred.
• 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 is preferred.
• Demonstrated ability to build collaborative relationships with key internal and external partners and stakeholders is preferred.
• Ability to influence, shape and lead without direct reporting authority is required.
• Experience in effective management of platform budget processes is preferred
• Neurovascular experience is preferred.Primary Location
Depuy Orthopaedics. Inc. (6029)Job Function
Clinical Research non-MD