Senior Director, Wound Biologics R&D

Life Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living. The Senior Director, Wound Biologics R&D is primarily accountable for leading the R&D activities required to advance one or more clinical-stage wound biologics products. The role works closely with Regulatory Affairs, Quality Assurance, Clinical, and Chemistry, Manufacturing and Controls (CMC), and requires sufficient knowledge across these disciplines to provide integrated leadership for the overall product development program. The leader will align cross-functional activities and guide the product through IND, Phase 1, Phase 2 and Phase 3 development, with progressive registration and commercialization readiness. This role requires direct, practical experience across R&D, clinical development, Chemistry, Manufacturing and Controls (CMC), and Regulatory Affairs. The successful candidate will integrate these disciplines as one development program, lead a matrixed team and provide clear recommendations on evidence, investment, risk, timing and value creation. The role does not replace the Medical Monitor, Regulatory authority, Quality authority or functional CMC owner. It provides the integrated leadership, governance and decision discipline needed to align those accountabilities and deliver the program.

What will you be doing?

- Lead the integrated development strategy and execution for wound biologics from IND-enabling and IND maintenance activities through Phase 1, Phase 2, Phase 3, marketing-application readiness and lifecycle planning.
- Own the cross-functional development roadmap, critical path, stage gates, budget, resource plan, risk register, decision log and executive governance cadence.
- Work closely with PMO to integrate R&D, Clinical, Medical, Regulatory, CMC/Technical Operations, Quality, Nonclinical, Biostatistics, Data Management, Manufacturing, Finance, Legal and Commercial inputs into one baselined plan.
- Lead internal experts and external partners, including CROs, CDMOs, laboratories, consultants, investigators and scientific advisors, while retaining company ownership of decisions, data and know-how.
- Create evidence-based recommendations for investment, indication sequencing, dose and regimen strategy, manufacturing readiness, pivotal development and registration pathways.
- Escalate material patient-safety, product-quality, compliance, clinical, regulatory, supply, funding and schedule risks early, with options and recommended actions.

1. Integrated R&D and program leadership
- Partner with PMO to define and maintain the integrated development plan, target product profile, milestone baseline, critical path, decision criteria and risk-adjusted scenarios.
- Translate scientific, clinical, CMC and regulatory information into clear trade-offs and recommendations for executive governance.
- Ensure unresolved assumptions and evidence gaps are explicit, owned and linked to development gates and health-authority questions.
- Align indication strategy and development priorities to unmet wound-care needs, intended claims, competitive differentiation, reimbursement considerations and portfolio value.
- Build a high-performing matrix team with clear role charters, decision rights, interfaces, escalation paths and closure criteria.

2. Clinical development: Phase 1 through Phase 3
- Partner with Clinical and Medical leadership to shape protocol strategy, dose and regimen selection, endpoints, study populations, safety surveillance and benefit-risk assessment across Phase 1, Phase 2 and Phase 3.
- Convert Phase 1 safety, tolerability, pharmacology and early activity findings into defined Phase 2 entry criteria, dose-selection logic and evidence plans.
- Use Phase 2 outputs to drive indication and regimen confirmation, endpoint selection, statistical assumptions, pivotal-study design and Phase 3 investment recommendations.
- Ensure Phase 3 planning integrates clinical operations, biostatistics, data management, medical monitoring, clinical supply, quality, regulatory commitments and inspection readiness.
- Maintain program-level oversight of enrollment, data quality, safety signals, protocol deviations, product availability, vendor performance and decision timelines without superseding medical or clinical authority.
- Ensure clinical evidence is generated with sufficient traceability and quality to support health-authority interactions, the marketing application and intended product claims.

3. IND and global regulatory strategy
- Partner with Regulatory Affairs to define and execute the IND strategy, including IND-enabling evidence, submission content, health-authority interactions, amendments, annual reports, safety reporting and regulatory commitments.
- Anticipate regulatory questions and ensure clinical, nonclinical and CMC workstreams produce coherent, submission-ready evidence.
- Lead integrated preparation for key health-authority milestones, including pre-IND, end-of-Phase 1, end-of-Phase 2 and pre-submission interactions, as applicable.
- Maintain the submission roadmap and progressive registration-readiness plan, with clear ownership of content, source documents, data standards, gaps and remediation actions.
- Assess the impact of clinical, manufacturing, analytical and supplier changes on the IND, comparability strategy, study execution and registration pathway.
- Bring a working understanding of relevant FDA requirements and ICH expectations for drug and biologic development, while partnering with accountable Regulatory and Quality leaders on interpretation and decisions.

4. CMC, manufacturing and clinical supply
- Provide integrated leadership of drug-substance and drug-product CMC strategy across development stages, ensuring the plan is fit for Phase 1, Phase 2, Phase 3 and registration.
- Align process development, scale-up, technology transfer, analytical methods, specifications, stability, comparability, validation strategy, control strategy and clinical supply with the clinical and regulatory plan.
- Ensure stage-appropriate manufacturing readiness, release testing, packaging, labeling, storage, distribution and product availability for each clinical study.
- Lead governance of CDMOs and critical suppliers across technical, quality, regulatory, contractual, supply, timeline and budget dependencies.
- Protect access to data, methods, process knowledge, reference standards and future transfer options; establish second-source or continuity strategies where justified.
- Identify CMC changes that could affect product performance, clinical interpretation, comparability, development timing or filing readiness and drive timely cross-functional decisions.

5. Quality, compliance and inspection readiness
- Partner with Quality to establish stage-appropriate GxP governance, vendor qualification, quality agreements, data-integrity controls, deviation and CAPA oversight, audit readiness and inspection preparedness.
- Ensure decisions, source documentation, analyses and development history are controlled, traceable and suitable for regulatory review.
- Promote a culture in which participant safety, product quality, scientific rigor and regulatory integrity are non-negotiable.
- Ensure external experts supplement capability rather than own company decisions; require knowledge transfer, documentation and exit plans for critical roles.

6. Portfolio, finance and executive governance
- Own the program budget, forecast, resource scenarios, commitments and contingency requirements in partnership with Finance.
- Prepare and lead operating reviews and executive governance discussions, including decisions, trade-offs, action logs and escalation follow-up.
- Prioritize work based on patient value, development risk, scientific strength, regulatory feasibility, supply readiness, commercial potential and return on investment.
- Communicate program status, changes, constraints and recommendations with clarity, transparency and appropriate evidence.
- Connect development choices to wound-care strategy, differentiation, launch readiness and lifecycle value.

7. Organization and capability building
- Mentor program and functional leaders and build durable internal capability in biologics development, CMC, regulatory integration and cross-functional program leadership.
- Develop a culture of ownership, constructive challenge, speed with discipline, timely escalation and measurable delivery.
- Recommend the appropriate mix of permanent employees, shared functions and targeted external expertise.
- Build productive relationships with clinical investigators, wound-care experts, academic institutions, development partners and external scientific advisors.

What will you need to be successful?

- Approved integrated development plan spanning IND, Phase 1, Phase 2, Phase 3 and registration-readiness milestones, with owners, dependencies and decision criteria.
- On-time, evidence-based development gates and health-authority interactions, with commitments and follow-up actions actively managed.
- Clinically and statistically credible study sequence, supported by documented dose, indication, endpoint and pivotal-development rationale.
- Executable CMC and clinical-supply plan with stage-appropriate specifications, stability, comparability, technology-transfer and validation pathways.
- Accurate budget, forecast, resource plan and scenario-based funding requirements.
- Timely executive decisions supported by concise, fact-based recommendations and transparent risk assessment.
- Reduced consultant and critical-person dependency through documented knowledge transfer and clear internal ownership.
- Timely closure of material risks, actions, regulatory commitments and governance decisions.
- Advanced degree in a life-science, pharmaceutical, biochemical engineering, medical or related discipline; PhD, PharmD, MD or equivalent advanced scientific degree preferred.
- 15+ years of progressive experience in pharmaceutical, biotechnology or biologics product development within regulated environments, including significant cross-functional leadership responsibility.
- Direct experience shepherding at least one drug or biologic program through IND and multiple clinical stages, including meaningful leadership exposure to Phase 1, Phase 2 and Phase 3 development.
- Demonstrated depth across R&D and working leadership experience integrating CMC and Regulatory Affairs, rather than operating solely within one function.
- Experience leading cross-functional teams spanning Clinical, Medical, Regulatory, CMC/Technical Operations, Quality, Nonclinical, Biostatistics and external development partners.
- Working knowledge of IND development and maintenance, health-authority interactions, GCP, GMP, GLP, biologics CMC, technology transfer, comparability, CDMO governance and clinical supply.
- Demonstrated ownership of integrated timelines, budgets, risks, governance and executive decision support.
- Experience operating in a global matrix and influencing senior functional leaders without relying solely on line authority.
- Excellent written and verbal communication, with the ability to make complex scientific, clinical, manufacturing and regulatory issues clear to executives and technical teams.

Preferred experience

- Wound biologics, topical biologics, regenerative medicine, tissue repair, burns, dermatology, enzymes, proteins or locally acting therapies.
- Experience with microbial fermentation, protein or enzyme drug substance, topical drug product, combination-product interfaces or advanced wound-care delivery systems.
- Leadership of a pivotal program and contribution to a biologics license application, new drug application or equivalent global marketing application.
- CMC technology transfer, process characterization, analytical-method lifecycle, comparability, process validation, audits and inspection readiness.
- External-manufacturing and CDMO partnerships, including technical agreements, quality agreements, supply continuity and performance governance.
- Experience transitioning a virtual, consultant-heavy or externally developed program into a durable corporate operating model.
- Commercial, market-access or portfolio exposure sufficient to connect development choices to value creation and lifecycle strategy.

Critical leadership capabilities

Enterprise accountability | Acts for the program, patient and company rather than a single discipline; creates clear ownership and closes gaps. |
Clinical-development judgment | Connects Phase 1 evidence to Phase 2 learning and Phase 2 outcomes to Phase 3 and registration decisions. |
Scientific and technical depth | Engages credibly across biologics R&D, clinical development, CMC and Regulatory and knows when specialist judgment is required. |
Execution discipline | Converts strategy into owners, milestones, budgets, decision criteria and measurable closure. |
Matrix leadership | Creates alignment across independent functions, geographies and external partners. |
Courage and transparency | Escalates risks early, distinguishes facts from assumptions and challenges constructively. |
Talent and capability building | Internalizes knowledge, develops leaders and builds sustainable organizational capability. |
Patient, quality and integrity focus | Places participant safety, product quality, data integrity and regulatory compliance at the center of decisions. |
Executive governance | Executive Steering Committee; VP, Enterprise Biologics R&D; R&D and business leadership |
Core functions | R&D, Clinical, Medical, Regulatory, Quality, CMC/Technical Operations, Nonclinical, Biostatistics, Data Management, Manufacturing, Finance, Legal, Compliance, Procurement and HR
External partners | CROs, CDMOs, laboratories, consultants, collaborators, investigators and scientific advisors |
Business partners | Advanced Wound Management, Commercial, Market Access, Corporate Development and external-funding stakeholders, as applicable |

Education - Bachelor's or Master's degree in Mechanical Engineering, Electrical Engineering, Biomedical Engineering, or a related engineering discipline.

You Unlimited.

- Inclusion + Belonging: Committed to Welcoming, Celebrating and Thriving. Learn more about our Employee Inclusion Groups on our website https://www.smith-nephew.com/
- Your Future: 401k Matching Program, 401k Plus Program, Discounted Stock Options, Tuition Reimbursement
- Work/Life Balance: Flexible Personal/Vacation Time Off, Paid Holidays, Flex Holidays, Paid Community Service Day
- Your Wellbeing: Medical, Dental, Vision, Health Savings Account (Employer Contribution of $500+ annually), Employee Assistance Program, Parental Leave, Fertility and Adoption Assistance Program
- Flexibility: Hybrid Work Model (For most professional roles)
- Training: Hands-On, Team-Customized, Mentorship
- Extra Perks: Discounts on fitness clubs, travel and more!

Smith+Nephew provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability.

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