About Ipsen:

Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology Rare Disease and Neuroscience. Supported by nearly 100 years of development experience with global hubs in the U.S. France and the U.K we tackle areas of high unmet medical need through research and innovation.

Our passionate teams in more than 40 countries are focused on what matters and endeavor every day to bring medicines to patients in 88 countries. We build a workplace that champions human-centric leadership and fosters a culture of collaboration excellence and impact. At Ipsen every individual is empowered to be their true selves grow and thrive alongside the companys success. Join us on our journey towards sustainable growth creating real impact on patients and society!

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SUMMARY OF THE POSITION

The Hyaluronic Acid (HA) Filler Program Lead is responsible for the evaluation development and lifecycle execution of HA filler assets supporting the build-out of a competitive global aesthetics portfolio.

The portfolio will be primarily built through external innovation with this role partnering closely with Business Development & Licensing to assess and progress external opportunities. The role does not define portfolio strategy but ensures that selected assets are rigorously evaluated and effectively translated into approvable and commercially viable products.

This position sits at the intersection of Business Development R&D Regulatory Medical and Commercial ensuring seamless execution from asset assessment through development industrialization regulatory approval and lifecycle management.

The HA Filler Program Lead acts as a central integrator and technical expert responsible for shaping development approaches and driving disciplined execution across internal functions and external partners.

As a recognized expert in HA injectable development you will lead the progression of assets from initial evaluation through to commercial readiness including:

• Assessment of product design and technical characteristics

• Definition of development and evidence requirements (clinical and non-clinical)

• Oversight of regulatory strategy and submission readiness

• Ensuring manufacturing and industrialization feasibility

• Alignment of product features with injector needs and commercial requirements

From asset selection through to market readiness you will drive execution balancing technical feasibility regulatory requirements and practical usability to ensure efficient compliant and high-quality delivery.

You will play a critical role in enabling the delivery of an innovative filler portfolio that complements our recombinant neuroinhibitor corabotase ensuring assets are not only approvable but also fit-for-use differentiated and competitive in clinical practice.

MAIN RESPONSIBILITIES

1. External Asset Evaluation & Integration

• Lead the technical and development assessment of externally sourced HA filler assets in close collaboration with Business Development & Licensing

Evaluate:

• Product design and performance characteristics (e.g. rheology usability)

• Clinical evidence and data packages

• Regulatory feasibility across key markets

• Manufacturing robustness and scalability

• Identify development gaps risks and requirements to ensure assets are fit for progression

• Provide clear cross-functional recommendations to support asset selection decisions

2. Development Strategy Translation & Program Planning

• Translate asset-level decisions into practical and fit-for-purpose development plans

Define:

• Evidence requirements (clinical and non-clinical)

• Regulatory pathways and submission approach

• Industrialization and technical readiness requirements

• Build and maintain integrated program plans covering timelines milestones risks and budget

3. End-to-End Development Execution

• Lead the execution of HA filler development programs from asset selection through to registration and commercial readiness

Drive cross-functional delivery across:

• Regulatory

• Clinical Development / Medical Affairs

• Quality and Manufacturing

• Supply Operations

4. Regulatory & Approval Delivery

• Define and drive global regulatory strategy execution for HA fillers

Ensure readiness for:

• CE marking (EU MDR)

• FDA and other key market registrations

• Oversee preparation of technical files clinical documentation and submission dossiers

• Manage interactions with regulatory stakeholders (internally and externally)

• Ensure compliance throughout development and submission

5. Manufacturing & Industrialization Readiness

• Ensure that externally sourced products are technically and operationally ready for scale-up and commercial supply

Collaborate with:

• External manufacturing partners

• Internal quality and supply teams

6. External Partner Management

• Act as the primary program lead for external partners (developers manufacturers licensors)

Ensure:

• Alignment on development scope and deliverables

• Delivery against agreed timelines cost and quality

• Drive performance through clear governance and escalation mechanisms

• Maintain strong constructive and performance-focused partnerships

7. Cross-functional Integration & Alignment

• Act as the central integrator across internal functions ensuring alignment between:

  • Technical/development requirements

  • Regulatory constraints

  • Commercial and medical needs

8. Lifecycle Management Execution

• Support and drive post-approval lifecycle activities including:

  • Geographic expansion

  • Indication extensions (where relevant)

  • Product updates and improvements

  • Ensure ongoing compliance and competitiveness of the portfolio

9. Governance & Reporting

• Prepare and present program updates risks and recommendations to governance bodies

• Ensure decision readiness through:

  • High-quality analysis

  • Clear articulation of trade-offs and risks

  • Maintain transparency and alignment with senior stakeholders

KNOWLEDGE & EXPERIENCE

• Advanced degree in a relevant scientific or technical discipline (e.g. Pharmacy Biomedical Engineering Life Sciences Material Science) preferred

• Additional business exposure (e.g. MBA or equivalent) is a plus but not required

• 10 15 years of experience of HA fillers injectables or comparable device-based technologies

• Proven experience in development and program leadership within a regulated environment (EU MDR FDA or equivalent)

• Strong track record in leading development of medical devices or injectables from evaluation through to registration and market readiness

• Experience working with:

  • External partners (manufacturers licensors developers CDMOs)

  • Cross-functional global teams (Regulatory Quality Clinical Manufacturing Commercial)

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