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R&D Global Process Owner- Early Development

Cambridge, Massachusetts Permanent Posté le   Feb. 19, 2025 Expire le   May. 26, 2025
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About the Job

Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress.

As the Global Process Owner for R&D, you will be responsible for leading, optimizing, and overseeing the global R&D processes, specifically for the Precandidate to the Proof of Clinical and Commercial concept stage, within a leading pharmaceutical company. You will work closely with R&D Leaders, cross-functional teams, subject matter experts and operational leads in R&D, partnering with regulatory, quality and other end to end organizations to ensure the consistent, efficient, and compliant execution of R&D processes worldwide. This role requires strong leadership, a deep understanding of the pharmaceutical R&D lifecycle, more specifically in the early Research space, and the ability to drive continuous improvement initiatives to enhance productivity, quality, and reduce time-to-market for new therapies.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main Responsibilities:

Process Ownership & Governance:

  • Own and oversee the global end-to-end R&D process from early development (Pre-candidate to Proof of Clinical & Commercial Concept (POCC)), ensuring it is effective, standardized, and scalable across all regions.

  • Establish, maintain, and continuously improve the R&D process framework for these processes, ensuring it aligns with R&D strategy, regulatory requirements, and industry best practices.

  • Define and implement R&D processes for Pre-candidate to Proof of Clinical and Commercial Concept standards, ensuring consistency and compliance with global standards

  • Drive the adoption of best practices and process optimization initiatives across R&D departments in the Early Development space including any other partnered functions.

  • Establish process governance structures, including regular reviews, and continuous improvement initiatives where applicable

Cross-Functional Collaboration:

  • Collaborate with senior leaders in R&D, Subject Matter Experts, Operational Leads, Regulatory Affairs, Quality Assurance, and Digital to ensure the processes are aligned with the business strategy and offer end to end delivery.

  • Act as a liaison between Early Development teams and other functional departments to facilitate process alignment and potential optimization, knowledge sharing, and integration of new technologies or methodologies.

  • Provide strategic guidance by collaborating with Operational Excellence experts to support R&D teams in resolving process-related challenges, ensuring that high-impact issues are addressed and resolved in a timely manner.

Change Management, Training & Knowledge Management:

  • Identify and support change management initiatives related to process updates, ensuring smooth adoption and minimizing disruption across global teams.

  • In collaboration with R&D Operations, develop and support delivery of training programs to R&D teams globally to ensure proficiency in new or revised processes and tools.

  • Ensure the creation and maintenance of a central knowledge repository for R&D processes, best practices, and lessons learned across the organization.

  • Act as a mentor and subject matter expert for R&D process owners and teams, offering guidance and support as needed.

  • Work closely with the R&D risk leader to identify key risks for R&D and determine the need for process optimization and standardization

Experience:

  • An advanced understanding of the processes needed to deliver from an early development space in R&D (ie. Precandidate to Proof of Clinical & Commercial concept)

  • Bachelor’s degree in Life Sciences, Pharmaceutical Sciences, Chemistry, Engineering, or related field (Master’s or PhD preferred).

  • Minimum of 8-10 years of experience in the pharmaceutical or biotechnology industry predominantly focused on the early development space, with at least 5 years in R&D operations or process management.

  • Proven experience in leading or managing cross-functional teams in a global, matrixed/networked organization.

  • Deep understanding of R&D processes, from precandidate to POCC, as well as regulatory and quality compliance in the pharmaceutical industry.

  • Experience in process optimization, Lean Six Sigma, or other continuous improvement methodologies.

Soft skills:

  • Strong leadership and change management skills, with the ability to influence and drive alignment across global teams.

  • Excellent communication and interpersonal skills, with the ability to present complex ideas to senior leadership and influence decision-making.

  • Solid project management skills, with experience in managing global initiatives across multiple stakeholders.

  • Able to influentially manage subject matter experts and operational leads to support analysis and delivery

  • Knowledge of R&D IT systems (e.g., LIMS, clinical trial management systems, electronic lab notebooks) and digital transformation tools in the pharmaceutical industry.

  • Analytical mindset with the ability to identify process inefficiencies, assess risk, and implement actionable solutions.

  • Fluency in English (other languages are a plus).

Technical skills:

  • Programs, Project and/or Change Management processes methodologies (e.g. MSP, PMP, Prosci) - Certification in this area a plus.

  • Knowledge of LEAN/Six Sigma/Continuous Improvement (CI) methodologies – Certifications in these areas a plus.

Why Choose Us?

  • Bring the miracles of science to life alongside a supportive, future-focused team.

  • Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.

  • Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

  • Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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