Senior Director, Global Clinical Strategy (AWM)Life Unlimited.
At Smith+Nephew we design and manufacture technology that takes the limits off living.
The Senior Director, Global Clinical Strategy is responsible for developing global clinical evidence strategies to support accelerated market access, expanded market adoption and secured access to products via close collaboration with internal and external stakeholders including healthcare providers, regulators, payers etc.
This person will sit on the franchise leadership team representing Clinical and Medical affairs to ensure the visibility of business needs and full alignment with clinical activities and priorities.
This person will ensure the early involvement of clinical throughout our New Product Development (NPD) process to identify comprehensive evidence needs for all intended markets with the goal of bringing products to markets in a shortened timeframe.
This person will also oversee timely evidence generation to support EU MDR (European Union Medical Device Regulations) and other global regulation compliance in a sustainable and efficient manner.
In summary, this person is the architect of the clinical strategies for the franchise and will deliver business value in partnership with both internal and external stakeholders.
This leadership role is a highly visible and influential role and will require strategic thinking, business acumen, exceptional communication, and partnership skills to be effective.What will you be doing?Serve as a member of the Franchise leadership team.
Partner with global and regional marketing, regulatory, market access and external stakeholders, and create evidence strategies to generate clinical and health economic evidence to expedite market access and expand market adoption for products and technologies.Serve as a member of the New Product Development Committee (NRC) to ensure timely evidence strategy development and execution to support regulatory approvals of the product in key markets where applicable.Oversee global evidence generation plan development and execution via close interaction with global clinical operations, medical affairs and evidence evaluation to ensure on-time delivery of impactful evidence and effective dissemination on all key products/technologies.
Drive the development and implementation of KPIs to drive alignment with business needs and business growth plan globally.Oversee the development and implementation of strategic engagement and partnership in research with KOLs and research centers to drive quality improvement of clinical research.Responsible for review and approval of clinical research projects following applicable of SOPs and compliance requirementsManage global clinical strategy team supporting team member's career developmentWhat will you need to be successful?Qualification and director level experience in engineering, design, scientific, clinical subject or related field:Knowledge and hands-on experience in designing and executing clinical studies.Experience in developing and implementing clinical evidence strategies to support regulatory approvals in various markets is preferred.Experience in interacting with regulators (e.g.
FDA, Notified body etc.)
and other policy makers.Knowledge and experience in review and assessment of scientific publicationsExperience with Microsoft Teams, Access, Excel, Word, Powerpoint, Outlook, Sharepoint, Visio and ProjectExceptional communication skills and ability to collaborate exceptionally well in a matrix environmentStrong business acumenAbility to see the big picture, and act as the chief architect of the clinical strategy for assigned businessDevelop and lead a high performing teamResults-focusedKnowledge of the business and customer stakeholdersKnowledge of national and international industry standards and best practices in clinical research processes, US Code of Federal Regulations, ISO 14155, ICH GCP, ISO 14971, EU MDRKnowledge of clinical and medical terminologyYou.
Unlimited.We believe in creating the greatest good for society.
Our strongest investments are in our people and the patients we serve.
Inclusion, Diversity and Equity: Committed to Welcoming, Celebrating and Thriving on Diversity, Learn more about our Employee Inclusion Groups on our website ()Your Future: Generous annual bonus and pension Schemes, Save As You Earn share options.Work/Life Balance: Flexible Vacation and Time Off, Paid Holidays and Paid Volunteering Hours, so we can give back to our communities!Your Wellbeing: Private Health and Dental plans, Healthcare Cash Plans, Income Protection, Life Assurance and much more.Flexibility: Hybrid Working Model (For most professional roles).Training: Hands-On, Team-Customised, Mentorship.Extra Perks: Discounts on Gyms and fitness clubs, Salary Sacrifice Bicycle and Car Schemes and many other Employee discounts.