Skip to main content
Two women in white lab coats look at a computer screen together

R&D - Clinical Research Director- BJ/SH

Shanghai, China
Beijing, China
Fixed Term Posted on   Dec. 12, 2024 Closing on   Mar. 01, 2025
Apply now

The role of the CRD is to:

  • Interact with other CRDs in the project, Global Project Head, The PV Rep, Regulatory and other key functional reps
  • Take on as necessary the Associate CRD role:
    • Provide medical expertise to the clinical studies (except select Exploratory Pharmacology studies) and/or registries (eg: protocol, Key Results, Clinical Study Report)
    • Support other clinical development activities (e.g. pressure test and cluster feasibility, medical review and validation of clinical data, study risk assessment)
    • Contribute to the Extended synopsis and Protocol for their project
    • Contribute to the clinical part of submission dossier for their projects: Common Technical Document for FDA & EMA submission, filing in Japan and China and answers to questions from health authorities
    • Provide appropriate medical input & support for all activities related to clinical studies such as medical training, feasibility, medical review of data, medical information for the study team, medical advisors/Clinical Project Leaders from Clinical Study Units, and investigators
    • Be the medical reference in the Clinical Study team, ensuring the medical relevance of the clinical data

Key responsibilities include:

Leading the clinical development plan strategies:

  • Responsible for the clinical development plans and clinical sections of integrated development plans (IDP)
  • Collaborate with other CRDs within the project, ensures leadership, builds consensus, coordinates action plans with stakeholders to resolve project-related study issues, anticipates potential issues (sharing lessons learned) across the project or study teams
  • Raise study or project-level issues to the project head
  • Contribute in the definition of the product value proposition (TVP), TPP and market access strategy (in collaboration with respective functions) and the focus of the research strategy, by providing input on existing clinical needs and approaches to clinical development strategies for research projects
  • Collaborate with external partners, regulators, and diverse internal stakeholders and collaborators
  • Evaluates relevant medical literature and status from competitive products

Lead, Support and oversee the execution of clinical development and studies activities

  • Review and validate the final protocol and protocol amendments
  • Review the ICF WSI and TDF
  • Assisted by related functions (e.g. clinical operations, project management, and procurement), responsible for timelines, budgets and contingency/risk management plans to assure successful execution of the clinical trials in compliance with Good Clinical Practice (GCP), applicable laws and regulations as well as applicable standard operating procedures (SOPs)
  • Lead the study specific committees (IDMC, steering com, adjudication …) with operational support
  • Co-Develop the SAP in collaboration with bio stats
  • Responsible for key results preparation
  • Develop the clinical study report
  • Take on as necessary the Associate CRD role:
  • Develop the abbreviated protocol
  • Develop the final protocol and protocol amendments
  • Medical support to clinical operation team during the clinical feasibility
  • Review and provide clinical input across different study documents written subject information, CRF, e-diary, monitoring plan
  • Medical support to clinical operations team on study plans: CMP/MRP, DR & DS review
  • Review/approve study-related documents (eg vendor specifications for centralized services, CRF, CRF completion guidance, patient diary, etc)
  • Participate in the elaboration of training material and presentations at the investigator meetings
  • Ensure continuous medical review of aggregated data during clinical trial conduct (DRSR, safety, stat outputs of blinded data, …) with operational support, bio stat and GSO
  • Answer to medical questions raised by EC/IRBs, sites
  • Support CRD trial master file documents readiness and availability, and mandatory trainings linked to the clinical function
  • Collaborate and communicate appropriately with all function stakeholders to ensure optimal study execution in compliance with Good Clinical Practice (GCP), applicable laws and regulations as well as applicable standard operating procedures (SOPs), including but not limited to:
    • feasibility managers for feasibility preparation and validation of feasibility results
    • Medical Writers to develop, review and finalize WSIs, study protocols and reports
    • Clinical Scientists, Medical review team and Coding
    • Pharmacovigilance (GSO, CME)
    • CTOMs, Biostatisticians
    • CSU medical advisors for the best knowledge of the study, compound, protocol
    • TA Experts, senior CRDS, global clinical lead, GPHs and medical affairs
    • CROs
    • Regulatory affairs
  • Collaborates with other CRDs within the project, ensures leadership, builds consensus, coordinates action plans with stakeholders to resolve project-related study issues, anticipates potential issues (sharing lessons learned) across the project or study teams. He/she raises study or project-level issues to the global project head and clinical lead
  • Provide operational expertise to project clinical sub team, as needed

Responsibilities related to regulatory and safety documents and meetings:

  • Review and/or contribute in the clinical section of the Investigator’s brochure, CTA, IND, DSUR, INDAR, DRMP, RMP
  • Contribute in the clinical sections of the BLA/CTD, Briefing packages for regulatory meetings, PSP/PIP
  • Ensures clinical data meets all necessary regulatory standards
  • Participates in Advisory Committee preparation

Scientific Data evaluation and authorship: Participate and author manuscripts and abstracts Support the planning of advisory board meetings Establish and maintains appropriate collaborations with knowledge experts Contribute on an ad hoc basis to specific tasks such as the evaluation of potential in-licensing candidates for I&I therapeutic area and serves as the clinical advisor to research teams

Experience

  • Understanding of pharmaceutical product development and life cycle management
  • Very good Scientific and medical/clinical expertise
  • Very good expertise in clinical development and methodology of clinical studies
  • Very good communication skills (verbal and written) for interactions across functional areas and for interactions with key regulatory agencies
  • Demonstrated capability to challenge decision and status quo with a risk-management approach
  • Ability to negotiate to ensure operational resources are available for continued clinical conduct
  • Fluency in written and spoken English
  • Very good teaching skills, demonstrated ability to assist and train others
  • Ability to work within a matrix model
  • International/ intercultural working skills
  • Open-minded to apply new digital solutions

China Specific Requirements:

  • To lead China clinical development plan with solid knowledge and comprehensive experience on drug development, by engaging CN and global multi-function teams; to represent CN team in GPT and governance review.
  • To be liaison between Sanofi R&D and related medical societies in CN, to lead CN KOL interaction for project and study related issues.
  • To provide clinical direction in CN submission strategy, to lead CN specific clinical topics, documents and dossiers in CTA, NDA and HA interaction.
  • To provide timely clinical support on study level issues in GSD to ensure the success of CN development strategy.
  • To be the primary contact for GPH and GCL for China strategy and issue discussion.

Minimum Level of any Required Qualifications: 

  • Medical Doctor (MD) is must, Master and Ph.D. is preferred; with 8+ years in pharmaceutical industry; 5+ years in global/clinical drug development; 3+ years in project management:
  • Clinical Physician experience in relevant TA is a plus.
  • Team management skill;

Pursue progress. Discover extraordinary.

Progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s discover extraordinary together.

At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.

Watch 'One day at Sanofi' and check out our Diversity Equity and Inclusion initiatives at sanofi.com

Apply Now
  • You have not viewed any jobs yet.

  • You have not saved any jobs yet.

Employee in sterile clothing working in a lab

Sanofi careers in China

From research and engineering to sales, we're all working toward the same ambitious goal – halving the time from discovery to therapy. Our people develop incredible careers, alongside 40 new innovative drugs and vaccines for China. We also support the national health department in preparing for China 2030. It's how we've become a China Top Employer and have continued to grow since opening our first China site in 1982.

Illustration of map pins on globe

Find out more about this location

Experience possibility

  • Your Saved Jobs

    Learn more
  • Cambridge Crossing

    We're bringing together 2,500 people from across our organization — R&D, Medical, Commercial and Global colleagues all working to realize the power of collaboration.

    Learn more
  • Innovation in Action

    Our flexible lab of the future will transform how we conduct research, while our innovation center will be fully integrated with existing R&D locations.

    Learn more
  • Sustainable and Green

    Our new facility was built to minimize the environmental impact — helping protect our planet and people. Using resources efficiently, we're providing greener, healthier workspaces.

    Learn more
  • Sanofi’s AI Centre of Excellence in Toronto

    The Centre is focused on using leading technologies to develop world-class data and artificial intelligence (AI) products to create value for the health sector.

    Learn more
  • Ama

    Ama puts her project management techniques and ServiceNow knowledge to use to help advance Sanofi’s Digital Data operating model. Learn how our team connects data and AI to do what’s never been done before.

    Learn more
  • Sanofi Canada's Philanthropic Efforts

    By chasing the miracles of science to improve people’s lives, we surprise ourselves with what we can achieve. Our team is humbled by the impact our efforts make.

    Learn more
  • Emmanuel

    Emmanuel, Head of the Sanofi Digital Accelerator, shares how his team builds digital solutions that enable patients to receive new treatments to help improve their lives.

    Learn more
  • Dimitrije

    Dimitrije shares insights into the work carried out by the AI Centre of Excellence in Toronto.

    Learn more
  • Ziv

    Read Ziv's first-hand account describing the reasons he chose to join Sanofi – and many of the reasons why he now chooses to stay.

    Learn more
  • When you grow, we all grow

    We strive to support your whole self with thoughtfully crafted rewards that benefit you physically, financially, mentally and socially. Whatever your role, you'll thrive in our inclusive teams.

    Learn more
  • Build a career with purpose

    Bring your passion to your role and impact millions of people around the world. You're in the driver's seat – just set your goals, and we'll provide the training and support that will get you there.

    Learn more
  • Bolder, better futures

    Change your life. And the lives of millions around the globe. How? By starting a career where you're supported to grow, while having a tangible impact and learning from the best.

    Learn more
  • Our locations

    We're in 60+ countries, all pulling together to define the future of healthcare. Wherever you work, you'll develop your career alongside experts, using technology to chase bigger breakthroughs.

    Learn more
  • Sanofi Stories

    At Sanofi every voice matters. Get to know the talented Sanofians shaping our future and pushing us toward our ambitious goals.

    Learn more
  • Sanofi at Cambridge Crossing

    Dubbed Sanofi at Cambridge Crossing, our new state-of-the-art facility will create an innovation hub promoting close collaboration and integration among business units. Join us and become part of a team dedicated to chasing the miracles of science that improve people’s lives.

    Learn more
  • Why Sanofi

    Get access to the tools, training, and support to reach your goals. By fulfilling your potential, you’ll help us achieve our aim of halving the time from discovery to therapy.

    Learn more
  • Our people & culture

    We're the first in Pharma to have a DE&I board. We also have Employee Resource Groups that create spaces for every Sanofian to be heard. Your voice matters – use it to shape our future.

    Learn more
  • Sanofi's Postdoctoral Program

    Designed for high-caliber Ph.D. graduates, Sanofi's Postdoctoral Program helps you advance your scientific career in a state-of-the-art environment.

    Learn more
  • Physician Careers at Sanofi

    At Sanofi, physicians like you have the opportunity to collaborate on new ideas and challenge established thinking. Learn about Physician careers here.

    Learn more
  • AI Centre of Excellence

    The AI Centre of Excellence at Sanofi is a unique data-driven team based in Downtown Toronto. We pride ourselves on being data-obsessed and highly focused on using state-of-the-art technologies to drive global impact.

    Learn more
  • Learn more
Two women, seated in an office lobby, working on laptops and talking

What could we achieve together?

Want to join our Global Talent Community? Every Sanofian works on projects that truly make a difference to people’s lives.

What could you achieve? Sign up today and discover our latest opportunities as soon as they’re available.