Senior Specialist, Global Clinical Strategy

Life. Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living.

We are currently searching for a Senior Specialist, Global Clinical Strategy .

The Senior Specialist, Global Clinical Strategy (Sr. Specialist, GCS) is responsible for designing, executing, and communicating clinical evidence strategies that support global new product development, product adoption, market access, and continued access for approved products. This role functions as a technical leader within project teams and may manage large-scope clinical evidence workstreams or major components of broader programs, in alignment with regulatory, scientific, quality, and business needs.

What will you be doing?

Clinical Strategy & Evidence Planning

• Understands assigned product/portfolio with respect to therapeutic area, treatment modalities, competitive landscape, regulatory classification and business direction for priority geographies.
• Establishes specific evidence requirements on assigned project/portfolio through literature review(s) and gap analysis.
• Develops and implements short-term/near-term evidence generation strategies addressing clinical, scientific, regulatory, market access, and commercial needs to support assigned product/portfolio.
• Authors clinical strategy options using appropriate strategic frameworks, with documented assumptions, rationale, risks, and decision traceability.
• Collaborates with cross-functional team(s) (GCMA and business partners) to ensure alignment of evidence strategy, deliverables and timelines.
• Recommends solutions to clinical strategy issues by integrating product, process, department strategy, and evidence requirements.
• Serves as the designated GCMA representative within New Product Development (NPD) processes across all phases of development.

Evidence Generation & Risk Management

• Identifies most appropriate clinical evidence generation method to meet the evidence requirement (SNIS and Non-SNIS activities).
• Recommends other evidence generation methodologies, when appropriate. Identifies risks, opportunities and trade-offs with selected evidence generation method.
• Proactively identifies areas of project risk in SNIS evidence generation activities and ensures timely resolution. Collaborates with GCMA functions ensuring appropriate processes/procedures are followed.
• Ensures compliance with applicable clinical study regulations including 21 CFR 312/812/50/54, ISO 14155, ISO 14971, GCP, Declaration of Helsinki, EU MDR, etc.

New Product Development

• Understands the product development lifecycle, including relevant regulations (ISO 13485, 21 CFR 820, ISO 14971).
• Provides therapeutic area knowledge and clinical opportunity for relevant product/portfolio to the NPD team. Functions as the GCMA project manager at NPD core team meetings.
• Supports NPD throughout the product development lifecycle. Prepares GCMA phase-gate exit slides.
• Supports new product launch activities through delivery of scientific/clinical evidence.

Market Adoption & Development

• Understands goals for market adoption and development opportunities.
• Partners with Marketing, Market Access/Health Economic Outcomes Research and other relevant business partners.
• Identifies most appropriate evidence generation method to meet evidence requirements.
• Supports evidence generation activities and documentation for clinical claims.

Quality, Regulatory Compliance & Support

• Understands applicable regulations for product/portfolio (EU MDR, FDA, etc.).
• Supports regulatory submissions. Writes, authors and maintains documents supporting clinical evaluations, including PMCF-Plans.
• Supports review of PSURs. Supports interactions with regulatory bodies.
• Trains to and follows applicable S+N procedures per training plan.

What will you need to be succesful?

• Bachelor's degree in biomedical sciences, engineering, design, or related scientific discipline (minimum). Master's or PhD preferred.
• Strong communication, project management, scientific writing, independent work, cross-functional collaboration, Microsoft Office proficiency, and reference management tool proficiency. Scientific Knowledge, Product & Market Trends, Regulatory Knowledge, Strategy Development, Medical Writing, Financial Acumen.
• Bachelor's plus 4 years relevant experience, Masters plus 2 years relevant experience, or PhD; experience in medical devices or pharmaceuticals across clinical, medical affairs, R&D, and/or regulatory roles preferred.

Predominantly office-based with occasional travel (under 15%).

You. Unlimited.

We believe in creating the greatest good for society. Our Strongest investments are in our people and patients we serve.

Inclusion and Belonging: Committed to Welcoming, Celebrating and Thriving on Inclusion and Belonging, Learn more about our Employee Inclusion Groups on our website (www.smith-nephew.com)

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.