Sr. Clinical Research Director, RST and DT.

2 months ago

Lafayette, United States Medtronic Full time

Careers that Change Lives

The Sr. Clinical Research Director, Robotic Surgical Technologies and Digital Technologies (RST + DT) reports to the VP, Clinical Research Surgical. This position is responsible for directing all global clinical research activities and programs to generate clinical evidence in support of the business. The Clinical Research Leader is responsible for developing the clinical strategy in alignment with the business, R&D and commercial strategies for the RST and DT Business Units. The leader is also responsible for designing and driving the execution of pre-market and post-market clinical trials globally, including driving outcomes and results, and collaborating for the dissemination of the resulting evidence to internal and external stakeholders. The goal of these programs is to develop the medical evidence necessary to demonstrate safety, efficacy, economic and quality of life outcomes for the performance of our products and therapies. Programs will support global regulatory approval, reimbursement coverage through comparative effectiveness evidence, therapy adoption and new indications. The RST/DT Clinical Leader helps set the strategy and manages/approves funding for external physician-initiated research programs (ERP) on a global basis in partnership with the ERP Lead for Surgical. In addition, the leader will collaborate closely with the Economic Evidence team to provide additional value to the business.

A Day in the Life

Lead global strategic clinical plan process, investment prioritization efforts, and area reviews. Create the global strategic clinical plan and lead the development of regional clinical strategies.
Lead 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. Provide strategic leadership to evidence generation activities including design of Clinical trials retrospective database analysis, meta-analysis, translation of clinical data to marketing messages and other health service research endeavors. Have a working knowledge of patient reported outcomes instruments, and development of value messages to satisfy stakeholder needs. Set the strategy and manage/approve funding for external physician-initiated research programs (ERP). Develop and maintain an extensive physician network globally to understand customer needs and convey the evidence supporting the preferential use of our products and therapies. Play a leading role in the development of evidence to support clinically and economically differentiated products for specific (emerging and developed) markets. Ensure that clinical trial design is aimed at fulfilling the common and unique needs of different geographies. Successfully create, initiate, and conduct studies consistent with the clinical strategy and business unit objectives. In collaboration with the clinical research organization this includes Clinical Investigation Protocol (CIP) creation, budget drafting and management, trial execution, publication and evidence dissemination. Direct trial concept assessment and creation with functional leaders’ support Ensure effectiveness of RST/DT global clinical activities through strong collaboration and communication with Geography, Clinical Function, Marketing, Research, Technology, Product Development and Operating Unit leadership regarding clinical research and link to the overall business strategy. Assume primary accountability for clinical trial strategy and execution. Interact directly with senior leaders and executives to bring awareness and achieve resolution of significant issues concerning products and therapies detected during clinical trials. Collaborate with Regulatory, Reimbursement, Healthcare Economics, and Marketing to develop and execute plans to utilize the results of clinical trials to advance business objectives. Work cross-functionally and with external advisors, consultants and investigators to direct publication plans to ensure dissemination of clinical and economic evidence through manuscripts, society meetings presentations, payer presentations, etc. Interface with representatives from key functional groups including field clinical and technical staff, Product Development, Marketing, Sales, Regulatory Affairs and Quality and local governing bodies. Ensure the publishing of results and collaboration with physicians to make known the outcomes of studies and corresponding medical advancements. Represent the RST and DT BUs on matters related to clinical evaluation of products and therapies internally and externally. Represent RST/DT business clinical research internationally and build deeper local market knowledge and connections regarding products and strategies. Support global product launches, training, and customer support plans. Collaborate with geography clinical and business leads to create local clinical strategies. Collaborate with Business Development in the identification, early evaluation, and due diligence of opportunities for investment or acquisition. Manage expenses within budget, maximizing effectiveness and efficiency. Work within and actively promote Medtronic’s core mission, corporate strategies, policies, procedures and Code of Conduct.

Responsibilities may include the following and other duties may be assigned.

Provides leadership for the conduct of clinical studies and for the regulatory affairs function as it applies to product approval. Studies must be scientifically valid, meet all relevant regulatory requirements and be conducted within ethical guidelines. The end result of the clinical studies must be a fair assessment of the safety and efficacy of the tested product (s) and attainment of product approvals in a timely matter. Develops and implements regulatory strategies to obtain timely product approvals form worldwide regulatory bodies. Ensures regulatory submissions are accurately prepared and comply with regulatory approvals. People working within region/country may also have the responsibilities that include: 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, oversees clinical research projects over all of the products and therapies within the RST and DT BUs. Must Have: Minimum Requirements
Bachelors degree required (Advanced degree, Master of Science, Ph.D., PharmD, or MBA highly desired)  Minimum of 15 years experience in clinical research in the medical device industry with IDE and PMA submission experience with 10+ years of progressive managerial experience in clinical research , or Advanced Degree with a minimum 13 years prior relevant experience, minimum of 10 years of managerial experience Nice to Have
Demonstrated ability to build deep product and therapy knowledge Demonstrated ability to work with FDA and other global regulatory agencies and bodies Work experience directly in a strategic clinical or marketing role Demonstrated ability of research skills for study design and analysis Demonstrated knowledge of Data Management and Clinical trial processes Understanding of dynamic clinical research environment, including global regulations and policies Strong interpersonal skills and ability to collaborate with and influence physicians, nurses, and regulators. Demonstrated ability to work with organizational decision makers – Executives, R&D, Marketing, Regulatory, etc. Ability to maintain proactive relationship with R&D, Marketing and Regulatory within CRM and Medtronic Demonstrated use of business and financial measures Excellent communication and presentation skills -- written and verbal Demonstrating ability to negotiate and utilize effective influencing and sales skills

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