Senior Manager, Global Clinical Strategy

Smith+Nephew•Minneapolis, MN

1d•Hybrid

About The Position

The Senior Manager Global Clinical Strategy will lead the development and execution of clinical and economic evidence strategies to support market access, new product development, increase market adoption and/or maintain registration. This role will support the Hips and T&E franchises within Orthopaedics. This role will support the rapid generation of clinical and economic evidence by leveraging and developing strategic partnerships both locally and globally, utilizing the most appropriate methodologies and tools for generating evidence and working closely with commercial, market access and regulatory stakeholders to ensure clinical activities are optimized and aligned with key business needs for the Ortho Hips and T&E Franchises.

Requirements

BS plus 7 years' experience or MS plus 3 years' experience.
Experience in engineering, design, scientific, clinical subject or related field.
At least 3 years' direct or indirect management experience.
Experience in orthopedics preferred.
Able to communicate complex concepts effectively
Experience in taking the initiative to negotiate and work closely with others; experience in building and executing evidence strategies for purposes of achieving product reimbursement
Experience presenting deep scientific topics to highly scientific and/or influential audiences; experience working across teams to solve ambiguity and drive to a decision point.
Self-motivated and able to work independently, whilst maintaining inclusive approaches.
Excellent time management skills and ability to work under pressure to deadlines.
Experience in developing talent.
Must exhibit high quality, ethical and compliant work habits.
Experience in using Microsoft Word, Excel, and PowerPoint.
Excellent scientific/technical writing skills.

Responsibilities

Responsible for crafting and driving high impact pivotal initiatives across the Orthopaedics portfolio.
Partner with Global and Regional Marketing, Regulatory, Market Access and external partners, and build evidence strategies including claims, publication strategy and conference submissions to generate clinical and health economic evidence to expedite market access and expand market adoption for Smith + Nephew products in the Ortho Hips & T&E franchises.
Supports new product development teams for the Ortho Hips and T&E to ensure timely evidence strategy development and execution, as well as clinical support for regulatory submissions to support regulatory approvals of the products in key markets where applicable.
Develops clinical strategies to ensure MDR readiness and compliance, working closely with Global Clinical and Medical Affairs functions to align on evidence sufficiency.
Drive and lead execution of PMCF activities and timely reporting to remain on schedule for MDR technical file submissions, Notified Body commitments, and audit readiness.
Support the development and implementation of strategic engagement and partnership in research with KOLs and research centers.
Participation in internal/external Global Clinical Strategy-related audits, and regulatory inspections as needed; Implement appropriate corrective and preventative actions (CAPA), if necessary.
Presents progress and results to internal stakeholders at all levels of the organization.
Contributes to development or updates of department standard operating procedures (SOPs), business processes, and policies.
Support regulatory documentation for new or existing products, as applicable. This may include development of responses for clinical-related questions received from regulatory authorities.
Ensure compliance to applicable processes, quality standards and regulations.
Attend professional conferences and surgeon training labs as appropriate.
Team Management, business needs gathering, stakeholder alignment, budget management and reporting.
Oversight and direct support of Ortho Hips and T&E portfolio of clinical activities and deliverables, including external liaison with KOLs and clinical consultants.