Global Clinical Strategy Lead, Ortho

Smith & Nephew - Memphis, TN (30+ days ago)3.7


ABOUT US

Smith & Nephew supports healthcare professionals inmore than 100 countriesin their daily efforts to improve the lives of their patients. We do this by taking apioneering approachto the design of ouradvanced medical products and services, by securing wider access to our diverse technologies for more customers globally, and by enabling better
outcomes for patients and healthcare systems.

We have leadership positions in:
Orthopaedics Reconstruction - joint replacement systems for knees, hips and shoulders
Advanced Wound Management - wound care treatment and prevention products used to treat hard-to-heal wounds
Sports Medicine - minimally invasive surgery of the joint
Trauma & Extremities - products that help repair broken bones

We have around 15,000 employees around the world. Annual sales in 2016 were more than $4.6
billion. We are a constituent of the UK's FTSE100 and our shares are traded on the London Stock
Exchange and through American Depository Receipts on the New York Stock Exchange(LSE: SN, NYSE: SNN)

SUMMARY

The Global Clinical Strategy Lead (CSL) will serve as the Clinical, Scientific and Medical Affairs (CSMA)
representative to the rest of the company (e.g. Marketing, R&D, and Program Management) for assigned therapeutic areas.

The CSL will identify gaps in clinical evidence for assigned new and existing products, while also developing
evidence plans to fill the gaps.

The CSL will work with other groups within CSMA to design robust clinical studies and then support the Global
Clinical Operations team during implementation.

ESSENTIAL FUNCTIONS

Develop Global Clinical Evidence Plans, including robust clinical study plans and publication strategies, for
assigned products
Develop relationships with Key Opinion Leaders (KOLs) in assigned therapeutic areas to develop evidence plans,
clinical study protocols, and publications in international peer-reviewed journals
Review proposed global investigator-initiated study proposals in assigned therapeutic area
Represent CSMA to provide clinical status updates at Product Development/Program Management meetings for assigned
product franchises.
Assist Global Clinical Operations team in site identification, protocol development, site trainings, and other critical activities during study implementation.
May include interactions with contract research organizations ICRO) and other vendors.
Serve as a reviewer and contributor to clinical study reports.
Support scientific and professional meetings, as needed, with assigned therapeutic areas.
Participate in due diligence assessments of new product business opportunities, as needed.
Support other functions by providing input and acting as a reviewer (e.g. post market clinical follow-up plans,
clinical evaluation reports, engineering change requests, post market surveillance reports).
REQUIREMENTS

Travel: Domestic & International – Up to 25%

Education: Master’s degree or equivalent in science or health-related field, or combination of equivalent education and experience in a medical or scientific setting. Additional training in statistics, study methodology, or clinical epidemiological approaches preferred.

Experience: Minimum 8-10 years’ experience in medical device industry or scientific/clinical research field required

COMPETENCIES

Ability to handle complex projects and manage multiple changing priorities
Ability to think strategically and communicate effectively (both written and oral)
Experience in clinical study design, preferably in the area of trauma and/or extremities medical devices
Knowledge of global medical device regulations and requirements
Advance knowledge of industry standards and best practices in clinical research, including ISO 14155 and ICH GCP
Other Experience with medical writing and publishing in peer-reviewed journals
Experience with Microsoft Office products Word, Excel, Powerpoint, Outlook, SharePoint, and Visio)
Experience with statistical programs, such as SAS or STATA is beneficial
Smith and Nephew is an Equal Opportunity/Affirmative Action Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by applicable law.