Senior Clinical Research Director – Pain

Senior Clinical Research Director – Pain

Requirements

• Minimum of 15 years of clinical experience (13+ with advanced degree) with 10+ years of managerial experience
• Prior Medical Device Experience

Responsibilities

• Provides leadership for the conduct of clinical studies and in the development of clinical evidence for pre-market and post-market trials/studies for the Pain therapy as it applies to product lifecycle
• Leads the process to define the key stakeholder needs (including but not limited to customer, regulatory agency and payer requirements) for medical evidence for the safety, efficacy, and economic outcomes necessary to establish our therapies as the standard of care.
• Provides strategic leadership to evidence generation activities including design of Clinical trials retrospective database analysis, meta-analysis, translation of clinical data to marketing messages.
• Ensures studies are scientifically valid, meet all relevant regulatory requirements and are conducted within ethical guidelines
• Ensures there is a fair assessment of the safety and efficacy of the tested product (s)
• Develops and implements regulatory strategies to obtain timely product approvals from worldwide regulatory bodies
• Represents Medtronic from a clinical research respective within the country / region and also collects feedback from local customers and authorities
• Builds and maintains a strong network and close relationship with the various internal and external parties
• Leads execution for both local and global studies, manages clinical research projects over the Pain therapy across multiple businesses

Preferred Qualifications

• Strong preference for an advanced degree (Master of Science, Ph.D., PharmD)
• Demonstrated ability maintain proactive relationship with Executives, R&D, Marketing, Regulatory etc. across Medtronic
• Demonstrated use of business and financial measures
• Ability to influence across functions and businesses to negotiate and gain cooperation on divergent objectives
• Strong strategic thinking, leadership, and communication skills. Proven record of driving business growth and innovation.
• People leadership skills to develop, motivate, and retain talent during a time of significant organizational change
• Effectively communicates both written and verbal at all levels in an organization, externally and with diverse groups. Position requires excellent poise and confidence when interacting with physicians, patients, sales, across organizational functions and senior leadership. Ability to summarize complex information in a clear and concise manner.
• Proven ability to operate in a matrix environment and work effectively with sales & marketing management as well as other functions including, regulatory, clinical, quality, reimbursement, research and development, manufacturing, finance, human resources, information technology and legal
• Proven record to work independently, while achieving aggressive personal and geographic objectives. Highly motivated, “can do” attitude with strong influence management skills
• Proven history of good judgment. Demonstrated integrity and respect of peers and broader team
• Must embody the Medtronic Leadership Expectations
• Experience developing and maintaining project plans for multiple projects and provide weekly and/or monthly status reporting to upper management.
• Understanding of dynamic clinical research environment including global regulations and policies