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A Range of Possibilities

R&D -Project Lead -Shanghai

date posted 01/06/2021
contract type Full time
job id R2580270
location Shanghai, China

#LI-Bruce

Who we are?

As a global healthcare leader and a Global Top Employer, we are as much a partner to patients facing health challenges as we are a partner to you on your career journey. We are focused on empowering our people to be agents of change, because the work we do will change health outcomes and empower patients’ lives. This is where you will have access to a broad track for all-round development as well as the platform to work as one team across one of the broadest healthcare and well-being portfolios globally.

Why start your career path in Sanofi?

Here, you can:

  • Copperate with strong, independent technology group and experience digital & innovative ways of working
  • Be viewed as a trusted partner, shared goals and quality work

What you can contribute?

Responsible for the clinical and administrative leadership of the China Clinical Development of the assigned project(s).  Works within the Global Project Team of RD\RBD Division: Discovery, Preclinical, Regulatory Affair, Quality, Pharmacovigilance, Medical, and Marketing, as well as with other key R&D departments to provide direction for all clinical development activities for the allocated project(s). Within China, overviews clinical development plan(s) with effective budget planning, development timelines, and ensure coordination with other functions and external stakeholders.

  • Member of the Global Project Team.
  • Within China, key representative persons with internal stakeholders, and especially Regulatory, Market Access, Medical Affairs, Quality, and Compliance.
  • External relationships necessary to ensure the allocated project(s) can obtain the necessary external authorisations, e.g. Regulatory Authorities, Experts, Advisory Boards, etc…

KEY ACCOUNTABILITIES

  • Drive with the allocated project(s) to ensure that China is as much as possible, and as early as possible, integrated in Global Simultaneous Development.
  • Drive alternative solutions, whether they are driven by regulatory issues, operational issues, or by strategic opportunities (e.g. CTW application).
  • Influence as a member of the Global Project Team to support the relevant strategy.
  • Provide scientific and medical leadership to both the China and Global teams involved in the designing of Clinical Development Plan(s), aiming at the most effective and timely clinical development activities to achieve the strategic goals for registration.
  • Work closely with the GPH of xx Division as well as other key R&D functional departments to provide direction for all clinical development activities within the allocated project(s).
  • Approve clinical documents according to Quality Documents, approve clinical budgets. Ensure compliance with budget and time constraints of the allocated project(s).
  • Ensure the best use of resources, so as to ensure increase in overall Clinical Development productivity.
  • Develop a positive working attitude within the team, and with the multiple company partners.
  • Ensure all trainings are appropriately executed, including those not directly linked to Clinical Development (e.g. Compliance).
  • Manage external relationships with Regulatory Authorities, Experts, Advisory Boards, etc…

What you should have?

  • Medical Doctor
  • At least 6 years of experience in Clinical Drug Development for a large pharmaceutical or a biopharmaceutical company
  • Strong medical background particularly within the therapeutic domain, background in Hematology and/or Rare diseases will be preferred  
  • Excellent understanding of the drug development processes and the regulatory framework for clinical trials.
  • Strong team player with Experience in leading multiple, diverse clinical development programs. 
  • Strong verbal and written communication skills, fluency in English, ability to work transversally
  • Ability to interpret clinical data accurately
  • Good understanding of biostatistics, pharmacokinetics, regulatory environment (China and Worldwide)

If you want to be part of a team that puts patients first, plays to win in digital era with courage, integrity, respect and trust, to inspire your own career journey through a care & collaborate platform, and with special focus on below competency:

  • Ability to analyze and summarize scientific and clinical data and develop recommendations that affect the conduct of studies and the content of regulatory submissions.
  • Cross-cultural experience in Clinical Drug Development Quality and Compliance oriented
  • Ability to drive change and innovation
  • Ability to work independently and think strategically Result-oriented and decision-making mindset Behavioral excellence

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

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Please note you are leaving the corporate site of Sanofi and are being redirected to our applicant tracking system, Workday, which allows you to apply to our open positions.

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