Biometry Manager Late-Stage Development -M - F- CDI H/F Pierre Fabre

Votre mission

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.

· Ensure appropriate resource planning, capacity management and prioritisation across projects.

· Support the professional development, coaching and career growth of team members.

· Build and maintain the capabilities required to support evolving business, scientific and regulatory needs.

· Drive employee engagement, performance management and succession planning within the team.

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.

· Identify, anticipate and mitigate operational, scientific and regulatory risks.

· Escalate critical issues and ensure timely resolution in collaboration with relevant stakeholders.

· 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.

· Ensure alignment between portfolio needs and the capabilities provided by the broader Biometry organisation.

Quality, Processes and Continuous Improvement

· Promote consistent application of biometry standards, processes and best practices.

· Ensure compliance with applicable regulations, guidelines and internal procedures.

· Drive continuous improvement initiatives to enhance quality, efficiency and predictability.

· 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.

· Champion the use of modern analytical approaches, automation and AI where appropriate.

External Engagement and Scientific Visibility

· Build and maintain strong relationships with peers in the pharmaceutical industry and academia.

· Represent Pierre Fabre in relevant professional societies, working groups and industry initiatives.

· Promote scientific visibility through conference presentations, publications and cross-industry collaborations.

· Strengthen the reputation of Pierre Fabre's Biometry Department internally and externally.

Qui êtes-vous ?

· 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.

Mandatory Skills

· Demonstrated experience as statistical lead or biometrics lead on at least one successful regulatory submission.

· Extensive experience supporting global regulatory submissions and health-authority interactions.

· Strong expertise in pivotal Phase III development, registration activities and regulatory strategy.

· Deep expertise in biostatistics supporting late-stage clinical development, regulatory submissions and health-authority interactions.

· Good understanding of regulatory requirements and industry standards, including ICH, EMA and FDA expectations.

· Demonstrated leadership and people-management experience.

· Ability to manage complex portfolios and competing priorities.

· Excellent written and verbal communication skills in English.

Optional Skills

· Experience managing outsourced biometrics activities and strategic CRO partnerships.

· Experience serving as statistical lead for marketing authorisation applications.

· Experience leading organisational transformation or process-improvement initiatives.

· Experience with modern statistical computing environments and data science technologies.

· Familiarity with AI-enabled approaches within drug development.

Terms of Employment

· Full-time position.

· Work location: On-site at either Toulouse Langlade or Boulogne, with the possibility of working from home up to 2 days per week or remote (France), with 4 days per month in Toulouse Langlade or Boulogne.

· 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...

Application Process

Interested candidates should submit their CV detailing their experience, leadership achievements and qualifications for the position.

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.

La première richesse des Laboratoires Pierre Fabre, sont les femmes et les hommes qui les composent disait M. Pierre Fabre.

Fiers de cet héritage, et convaincus que la diversité des parcours, des expériences et des identités renforce notre performance collective, nous nous engageons à promouvoir l'égalité des chances et à garantir un environnement inclusif pour tous. Dans le respect des lois en vigueur, toutes les candidatures sont étudiées avec la même attention, sans distinction d'origine, de sexe, d'âge, de situation de handicap, d'orientation sexuelle, d'identité de genre, de croyances ou de toute autre caractéristique protégée par la loi.