HireDiversity

Raynham, MA, US

DIRECTOR, CLINICAL RESEARCH-5390121213

Description

Codman & Shurtleff, a Johnson & Johnson company is recruiting for a Director, Clinical Research, located in Raynham, MA.

DePuy Synthes Companies include Joint Reconstruction, Trauma, Spine, Mitek Sports Medicine, Cranio-maxillofacial, Codman, Power Tools and Biomaterials. These companies are global leaders in providing surgical and non-surgical solutions in orthopaedics and neurologics, including products for reconstructing damaged or diseased joints; repairing and reconstructing traumatic skeletal injuries; facilitating the treatment of spinal disorders and deformity; repairing soft tissue injuries; and treating neurological and central nervous system disorders.

The Director, Clinical Research directs study design, protocol development, and execution of clinical research in all phases. This individual develops and drives the goals and activities of the Clinical Research Department such as designing, planning, developing, and monitoring of clinical evaluation projects. This person will be responsible for the compliance of department, company, and regulatory standards and procedures. Contributes to product risk/benefit analyses. Provides clinical insight into the NPD process. Represents the company as a peer within the external clinical community.

Interfaces with key members of the Research & Development organization to drive clinical strategy and contribute to the success of the portfolio. Reviews and determines results of all clinical investigations in preparation for submission to regulatory agencies. Assesses Internal/External clinical research proposals involving company products relevant to Codman's objectives. Acts as a liaison between Codman or Codman Neurovascular and clinical investigators. Develops credible relationships with opinion leaders, medical directors, and key regulatory officials. Performs medical monitoring/reporting and medical safety officer activities, including post marketing surveillance and health hazard evaluations. Develops and amends current Clinical Research Agreements in partnership with our investigators, research institutions, and vendors, including pre-market and post-market agreements. Balances resources, budgets, and priorities across clinical trials for multiple projects. Coordinates the review and approval of agreements in conjunction with our legal and HCC departments to drive global operational efficiency and compliance. Insures physician payments are at fair market value. Provides periodic reports on agreement status to senior management. Participates in Health Care Compliance Audits as needed and serves as a Medical Liaison and consultant for marketing efforts. Assist in writing and developing clinical protocols, case report forms, other data and tracking forms, informed consent documents, and operating procedures. Communicate with DSMB or adjudication committees when appropriate. Conduct data audits to ensure safety reports are timely and accurate. Plans, manages and monitors daily activities of clinical research. Ensures that all activities are in compliance with department safety practices, policies and procedures. Performs full management of investigator sponsored studies and acts as liaison with study site. Implements clinical study parameters, deliverables, policy compliance and resource needs. Applies scientific discipline to minimize risk and increase performance. Participates on cross functional teams for evaluation of new product ideas, implementation of business strategies, and so on. Manages analysis and documentation of company clinical work to determine marketability of products. Evaluates results of phase 1-4 investigations, in preparation for Premarket Approval and 510K applications and/or NDAs to regulatory agencies. Monitors and reports findings to senior management. Reviews and submits reports, registrations and submissions. Assesses internal/external clinical research proposals involving company products relevant to company's objective. Prepares and implements annual operating and capital budgets. Manages project budgets and projections. Hires, trains and evaluates staff. Ensures that the staff has the necessary guidance and tools for performance of various projects. Provides technical expertise to formulate clinical development plan.

Qualifications


A PhD/MD with 9 years of experience is required. An MD with clinical practice experience and 7 years of experience is preferred. Clinical trial design experience is required. Knowledge of interventional neuroradiology procedures, neurophysiology, neuropathology, or one of the Neuroscience disciplines is preferred. Excellent presentation and communication skills are required. The ability to act as mentor and resource to the clinical research associates in the department is required. The ability to travel up to 50%, both domestic and international is required.

BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.

Primary Location:North America-United States-Massachusetts-Raynham
Organization: Codman & Shurtleff Inc (6087)
Travel:Yes, 50% of the time