Director of Clinical Affairs

SUMMARY:  Responsible for strategic leadership relative to design of clinical studies and interpretation of established literature and Truvic clinical data.  Interacts with both internal and external customers to facilitate clinical programs.  May select, develop, and evaluate personnel to ensure effective support of Truvic clinical programs.  This position contributes to and supports the company’s research and development efforts to create high value medical devices to address unmet clinical needs.  Manage aspects of clinical operations for early feasibility and other studies.  This includes operational leadership relative to planning and executing clinical studies and overseeing data collection and monitoring activities. 
 
 ESSENTIAL DUTIES AND RESPONSIBILITIES include the following: 

Provide strategic leadership and design input for clinical studies including interacting with Key Opinion Leaders on clinical study designs and protocols

Research, review, analyze, and interpret literature and apply to clinical trial designs and develop proposals to regulatory agencies

Review, analyze, and interpret clinical trial data

Manage internal and external clinical statistical analyses to meet objectives

Write clinical aspects of core study and regulatory documents including clinical research plans, protocols, investigator brochures, clinical study reports and regulatory submissions

Serve as a scientific and clinical resource and adviser within Truvic including providing guidance to Clinical Trials Management, Regulatory, R&D, and Project Management staff

Part of a team responsible for managing the preparation and/or review of data listings, summary tables, study results, study reports, and clinical IDE sections

Prepare presentations for scientific conferences, investigator meetings, and expert advisory meetings

Develop and review scientific publications

Assist in clinical evaluation of business development opportunities

Evaluate and manage investigator-initiated research proposals

Prepare and maintain Clinical Evidence Reports

May be required to contribute to operational aspects of the clinical function including: 

Identify project sites, define budgets and time required to complete a clinical study concept

Develop/edit/approve protocols, case report forms, and database specifications

Recruit investigators / study sites and negotiate support levels

Ensure appropriate regulatory controls (site and patient) are in place for all study activities

Manage clinical trial agreements and internal and external review process

Review Regulatory documentation for completeness and accuracy during study initiation and maintain such documentation throughout the study

Ensure site adherence to the study protocol, relevant SOPs, GCP/ICH guidelines, HIPAA, trial registration, and all other applicable regulatory guidelines

Assist site personnel with data changes as needed to ensure clarity and accuracy of data

Develop/edit/approve protocols, case report forms, database specifications, and statistical plans

Perform risk analysis of protocols with investigator and internal stakeholder input

Other Responsibilities

Actively promote and support the Quality Management System, Quality Objectives, Quality Policy, and Management Review process

Stay up to date on training and ensure training of functional subordinates (if applicable) on all applicable procedures and processes according to Good Manufacturing Practices, applicable FDA and Regulatory requirements

Inform responsible personnel of concerns involving product quality

Perform job functions in a safe and effective manner

Other duties as assigned

EDUCATION/EXPERIENCE:                                                                                                                                           

Bachelor’s degree in related field and 8 years’ clinical research management experience, preferably in medical device industry

Master’s degree (MBA, MSN, MS) or Doctorate highly desirable

Extensive knowledge of FDA requirements, hospital, and health care environments

Strong knowledge of GCPs

5 years’ experience in direct management of clinical teams required

Excellent written and verbal communication skills required

Experience interacting with physicians, clinicians, and patients

Must be willing to travel 20 - 30%   

Possesses excellent leadership skills and ability to be very flexible, adaptable, and to work under pressure

Self-motivated and self-directed; conscientious approach to work assignments; enjoys the challenges of multitasking and working at a fast pace while staying flexible to shift tasks frequently

Excellent interpersonal and negotiating skills; ability to adapt to changing work priorities; and ability to maintain good working relationships while dealing appropriately with sensitive and confidential matters and with a wide variety of personal and telephone contacts

Demonstrated record of success and leadership

Demonstrated success in developing complex clinical affairs strategies across multiple product lines across multiple multi-national geographies