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Head of Pharmaceutical Development

il y a 2 semaines

Greater Montpellier Metropolitan Area, France Medincell Temps plein

Medincell
is a commercial-stage pharmaceutical company developing long-acting injectable drugs in many therapeutic areas. Products of our portfolio are based on our BEPO technology and aim to ensure patient compliance, improve the effectiveness and accessibility of treatments and reduce their environmental footprint. We collaborate with tier one pharmaceuticals companies and foundations to improve Global Health through new therapeutic options.

We have an exciting opportunity available for a well-rounded
Head of Pharmaceutical Development
to steer our development activities and lead a high-performing team. This is a unique opportunity to shape the future of drug delivery, drive operational excellence, and make a global impact. This strategic role reports to our Chief Operating Officer and oversees mainly the following activities: CMC Transfer, Vendor Compliance and Manufacturing Engineering and Process Development.

Keys responsibilities

Strategic Leadership & Execution

  • Define and implement the pharmaceutical development roadmap, aligning with Medincell's ambitious growth objectives.
  • Lead and implement a fit-for-purpose technical operations strategy, ensuring projects meet quality, regulatory, and corporate goals.
  • Serve as the senior expert across CMC, clinical supply, technical, quality, regulatory, and program operations.
  • Provide strategic guidance to the COO and executive team on activity status, risks, resource allocation, and timelines.
  • Bring deep expertise in CMC regulatory strategies and hands-on experience, navigating complex regulatory environments.
  • Oversee GMP-compliant initiatives and foster long-term partnerships with external stakeholders.Promote and nurture a strong pharmaceutical culture within the company.

CMC Transfer Oversight

  • Oversee product/process/analytical transfer processes, including strategy, vendor selection, performance monitoring, and risk management.
  • Ensure quality and regulatory compliance, acting as a key interface with partners and stakeholders.
  • Coordinate with the PMO and partners for successful execution of transfer plans and timelines.
  • Facilitate cross-functional collaboration between R&D, Quality, Regulatory, Analytical, and Manufacturing teams.

Vendor Compliance and Clinical Trial Supply Oversight

  • Oversee GxP vendor qualification, auditing, and performance monitoring.
  • Ensure quality documentation and regulatory compliance across all partners and vendors.
  • Drive pharmaceutical quality and regulatory compliance initiatives in collaboration with QHSE.
  • Oversee Clinical Supply Chain activities from vendor selection to study completion

Manufacturing Engineering and Process Development Oversight

  • Lead process design, feasibility, optimization, and scaling-up of manufacturing for GLP and GMP batches.
  • Apply Quality by Design (QbD) principles and oversee technical packages, process transfers, and validation activities.
  • Ensure all engineering and maintenance activities are compliant with technical, quality, regulatory and safety standards.
  • Coordinate with the Project Portfolio Management Office (PMO) and partners to ensure successful execution of manufacturing plans and timeline.
  • Contribute to the assessment of new technologies when required.

Project & Resource Management

  • Manage multiple development programs, ensuring timely delivery and efficient resource allocation.
  • Oversee external partnerships and contracts related to pharmaceutical development and manufacturing.
  • Implement project tracking tools and KPIs to monitor progress and mitigate risks.

Team & People Management

  • Build and scale a high-performing Pharmaceutical Development team.
  • Mentor and develop talent, promote a culture of innovation, accountability, and continuous improvement.
  • Lead change management initiatives and foster team engagement.
  • Promote a culture of innovation, encouraging creative and agile thinking to turn challenges into opportunities and drive continuous improvement.
  • Foster a culture where the team is empowered to take calculated risks and make well-informed decisions, ensuring that innovative approaches are balanced with strong regulatory and operational standards.
  • Promote a "straight to the point" mindset within management practices, aiming to streamline processes and mechanics, reduce complexity, and focus on high-impact actions.

Requirements

  • Advanced degree in Pharmaceutical Sciences, Chemical Engineering, or related field (PhD, PharmD, or equivalent preferred).
  • 15+ years in pharmaceutical development, including leadership roles in CMC operations, clinical supply oversight, involvement in CMC regulatory and quality-related activities, multiple vendors management.
  • Proven track record of leading CMC programs through early and late-stage development (i.e. successful tech transfer of at least 10 products to CDMOs with documented quality and timeline metrics), in various therapeutic areas, within the biotech/pharma industry.
  • Strong knowledge of global regulatory requirements (FDA, EMA, ICH) and GxP standards. Proven experience in crafting high quality documentation supporting successful CTA/NDA submissions.
  • Strong business experience, with expertise in budgeting, forecasting and vendor management.
  • Proven ability to operate in multicultural contexts and navigate various regulatory frameworks.
  • Fluency in English, French being a plus
  • Strong interpersonal and leadership skills; ability to communicate effectively across technical and non-technical stakeholders.
  • Strategic thinker with a hands-on approach, strong project management skills, and a collaborative mindset.

Medincell
is an equal opportunity employer committed to fostering an inclusive and respectful workplace. We welcome applications from all backgrounds and believe that diversity strengthens our teams and drives innovation.