Global Project Head, Oncology
Cambridge, Massachusetts, Vitry-sur-Seine, France
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"At Sanofi, We are guided by a deep appreciation and understanding of what it means to live with a rare blood disorder, and we learn by listening to the community – patients, caregivers physicians, and other healthcare professionals."Shannon Resetich US Head Rare Diseases & Blood Disorders
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The Global Project Head drives worldwide clinical development and life cycle management for a late stage Sanofi compound within chronic GvHD post-hematopoietic stem cell transplantation and across related indications. He/She leads the GPT (global product team) to ensure optimal development of the global compound development strategy in collaboration with the GBT (global brand team).
In this assignment he/she will be accountable for the compound clinical development strategy and execution, with a focus on registration-enabling studies and including budget planning. In collaboration with the Global Project Manager, he/she will lead the cross-functional GPT, including the regulatory, drug manufacturing, safety, medical and commercial compound leads, to ensure correct planning and implementation of end-to-end compound strategy. He/she will represent the Clinical Development function at the cross-functional GBT responsible for commercial brand strategy. He/she will present and discuss development strategy with key internal stakeholders, external investigators and advisory boards, and worldwide regulatory authorities.
Clinical Leader(s) and Clinical Research Director(s) in the program report to the Global Project Head (GPH) and he/she is responsible for their direction, mentorship, assignments and deliverables. The GPH will also have oversight authority on operational functions supporting the program
Medical degree or equivalent
7 or more years of experience in early or late stage clinical research and development in the biotech or pharmaceutical industry
A good understanding of global drug development process and of functional roles and responsibilities
Experience in successful NDA/BLA submissions
Experience in Hemato-oncology or Transplant medicine
Experience in leadership of cross-functional clinical teams
Excellent written and verbal communication skills
Oncology/Hematology MD with stem cell transplantation experience preferred; alternatively, Internal Medicine MD with solid organ transplantation experience
Experience in drug development in hematology or transplantation
Strong demonstrated leadership and clinical expertise in the field for effective international collaboration with external and internal stakeholders.
Experience preparing regulatory submissions, and in discussion and negotiation with health authorities.
Experience in collaboration with commercial and medical functions within launch or post-launch settings
Experience working in matrix environment, ability to integrate all aspects of the projects and their potential impact on the clinical strategy, ability to propose new applications to support product and / or business expansion, ability to develop strong networks internally and externally beyond initial field of expertise.
Experience in regional alliance partnerships or co-development
Strong interpersonal and cross-cultural communication skills for bridging between clinical and business or regulatory participants and take account of marketing, payer and regulatory needs.
Ability to define clear, challenging and realistic goals and appropriately assess the balance of investment and deliverables.
Experience managing high performing direct reports.
Results and customer focused.
At Sanofi R&D North America, we deliver meaningful solutions for patients. We transform science into breakthrough, best-in-class and first-in-class medicines and vaccines. We believe in creating a diverse and inclusive workforce – and workplace – which brings together the collective brainpower of over 2,000 colleagues and provides you with an exciting place to grow and develop. We set the bar high, and we deliver. Join us and together we will build on our trusted legacy of breakthroughs for society.
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.
As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.
According to the CDC, an individual is considered to be “fully vaccinated” fourteen (14) days after receiving (a) the second dose of the Moderna or Pfizer vaccine, or (b) the single dose of the J&J vaccine. Fully vaccinated, for new Sanofi employees, is to be fully vaccinated 14 DAYS PRIOR TO START DATE.
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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