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)
The Clinical Strategy Lead (CSL) will be the GCD representative for the franchise team providing strategic clinical direction for the life cycle of that Franchise portfolio of products.
This will be accomplished by CSL awareness of franchise priorities to align clinical resources accordingly and plan ahead. From the franchise and overall perspective, the CSL will have a clear understanding of the company's current global investment in evidence collection including SNIS, IIS, VoC, LMRs and therefore set strategies to identify and fill any gaps.
The CSL is responsible for developing "Global Clinical Evidence Plans" including short and long term strategy, development of methodologically sound clinical study synopsis and clinical study plans with publication strategy, reviews and summaries as well as critical appraisal of the relevant literature, review claims, IFUs, product extensions, and new indications in their franchise team.
GCD representative for one or more franchise teams and will actively participate in the respective monthly franchise committee meeting and GCD meetings
Liaise with ASD product teams and in-country sales and marketing personnel, to ensure effective study alignment with product strategy throughout the design, implementation and lifetime of the study/ies.
Develop "Global Clinical Evidence Plans" including short and long term strategy, development of methodologically sound clinical study synopsis and clinical study plans and publication strategy, reviews and summaries as well as critical appraisal of relevant literature, review claims, IFUs, product extensions, new indications in their franchise team.
Is required to be aware of all ongoing IIS, SNIS, VoC and LMRs for the assigned franchise team as well as planned publications through utilization of relevant dashboards.
As needed, participate in due diligence assessments of new product business opportunities.
Provide updates of franchise needs and forecasting resource demands to GCD management and clinical study teams.
Work closely with the CSM, data management group and biostatisticians from study design through to reporting of results.
Assist Clinical Study Managers as needed in training investigators, research coordinators, Contract Research Organizations (CROs), central laboratories, and other study vendors on methodological study procedures. Support scientific and professional meetings consistent with franchise responsibility.
Identify and establish professional relationships with KOLs, potential study investigators and professional organizations to support Global Clinical Evidence Plan development and maintenance.
Develop publication plans for each SNIS prior to the beginning of the study and contribute to scientific publications in international peer-reviewed journals and other publications, conferences, and other media, as appropriate.
Identify and implement process improvements by providing innovative and creative insights to department SOPs and policies.
Participate in internal/external GCD-related audits, and regulatory inspections as needed; Implement appropriate corrective and preventative actions (CAPA), if necessary
TRAVEL: Domestic & International up to 25%
EDUCATION: Master's Degree or equivalent in science related/health field, or combination of equivalent education and experience in a medical or scientific setting. Additional training in methodology or clinical epidemiological approaches preferred.
EXPERIENCE: Minimum of 8-10 years of experience in medical device industry, clinical study methodology setting or scientific/research field required
- Ability to handle complex projects, and demonstrates flexibility in managing changing priorities, strategic problem solving and judgement skills.
- Trained to think strategically and experienced in clinical study methodology.
- Experience in identification of sites and investigators
- Advanced negotiation and written and verbal communication skills in English
- Advanced knowledge of industry standards and best practices in clinical data management, US Code of Federal Regulations, ISO 14155, ICH GCP
OTHER: Experience with medical literature reviews and publication policies; Experience with Clinical Trial Management Systems