Biometry Manager, Late-Stage Development- M/

Il y a 1 jour

Toulouse, Occitania, France Laboratoires Pierre Fabre Temps plein
Pierre Fabre is a global pharmaceutical company dedicated to the research, development, and commercialization of innovative drugs. Our Biometry Department is integral to our success, providing comprehensive support for all drug development initiatives, including Randomized Controlled Trials (RCTs) and Real World Evidence (RWE) studies. We are seeking an experienced and inspiring Biometry Manager to lead our Late-Stage Development Biometry Team. This senior leadership role is responsible for managing a multidisciplinary team of statisticians and data managers supporting Pierre Fabre’s late-stage clinical development portfolio, including pivotal Phase III studies, registration activities, regulatory interactions and evidence generation to support market access. The successful candidate will ensure the delivery of high-quality biometry support across the portfolio while driving scientific excellence, operational performance, talent development and stakeholder satisfaction. Working closely with Clinical Development, Regulatory Affairs, Medical Affairs, Real-World Evidence, Pharmacovigilance and other R&D functions, the Biometry Manager will contribute to the successful execution of Pierre Fabre’s development strategy and represent Biometry in key governance and portfolio discussions. The successful candidate will be a member of the Biometry Leadership Team and play a central role in shaping the future direction of the Biometry Department. Your role within a pioneering company in full expansion: Team Leadership and People Development
• Lead and develop a multidisciplinary team of statisticians and data managers supporting the Late-Stage Development portfolio.
• Foster a high-performance, collaborative and scientifically rigorous culture.
• Build and maintain the capabilities required to support evolving business, scientific and regulatory needs. Portfolio Leadership
• Provide strategic oversight of pivotal Phase III clinical studies and registration programmes and health-authority interactions.
• Ensure effective delivery of data management and statistical activities across the assigned portfolio.
• Ensure delivery of high-quality, compliant and inspection-ready biometry outputs.
• Lead and provide strategic biometry input to regulatory submissions and health-authority interactions. Strategic Collaboration and Business Partnership
• Act as the primary Biometry partner for late-stage development.
• Build strong relationships with leaders across Clinical Development, Medical Affairs, Regulatory Affairs, Pharmacovigilance, RWE and other functions.
• Contribute strategic biometry input to portfolio reviews, development plans and governance discussions.
• Support business development activities, due diligence assessments and evaluations of external opportunities as needed. Quality, Processes and Continuous Improvement
• Promote consistent application of biometry standards, processes and best practices.
• Ensure compliance with applicable regulations, guidelines and internal procedures.
• Partner with all Biometry teams (Biometry Early-Stage Development, Biometry RWE, Biometry Excellence and Statistical Programming) to implement innovative methodologies, technologies and ways of working. Your skills at the service of innovative projects:
• Advanced degree in Statistics, Biostatistics or a related quantitative field (Master's Degree or PhD). (Master's Degree or PhD).
• 12-15+ years of experience in pharmaceutical development, including extensive experience in biostatistics supporting late-stage development and regulatory submissions.
• Proven experience leading teams within a pharmaceutical company or Contract Research Organisation.
• Proven track record supporting pivotal Phase III studies and successful EMA/FDA regulatory submissions.
• Demonstrated experience working within complex cross-functional environments.
• Experience in oncology or another therapeutic area relevant to Pierre Fabre would be an advantage.
• Excellent written and verbal communication skills in English. Work

location:
On-site at either Toulouse Langlade or Boulogne, with the possibility of working from home up to 2 days per week.

We offer
an attractive remuneration/benefits package: Incentives, profit-sharing, Pierre Fabre shareholding with matching contribution, health and provident insurance, 16 days of holidays (RTT) in addition to 25 days of personal holidays, public transport participation... The Head of the Biometry Department is Guillaume Desachy. We look forward to welcoming a collaborative and visionary leader in the Biometry Department, who will help accelerate the delivery of innovative medicines through excellence in biometry and data-driven decision-making.