Director Clinical Development H/F
Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Our Sanofi Pasteur Swiftwater, PA site, where we both research and manufacture vaccines since 1897, has had a tremendous impact on global health and the quality of human life. Nestled among the Pocono Mountains in Swiftwater, Pennsylvania, Sanofi Pasteur is home to state-of-the-industry facilities—and a rich and unique history. Our Swiftwater campus is more than 500 acres, housing 44 buildings and encompassing more than one million square feet of building space. Many of our facilities, while bright and modern, still retain the rustic charm of the original stonework.
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We are seeking a highly motivated medical doctor / PhD Scientist to join the Global Clinical Sciences team of Sanofi Pasteur.
Within Sanofi Pasteur Research and Development, and more specifically the Global Clinical Sciences Department, and within the guidelines given by the Clinical Franchise Leader, the Clinical Team Leader (CTL) is a key member of the Project Team and the Clinical Team.
The R&D project team, plans, develops and manages the project strategy, in order to obtain registration of a new product or improvement of a vaccine for the prevention and / or treatment of the disease. The CTL is responsible for the clinical development strategy and is thus a core member of the R&D Project team.
The Clinical Team is responsible for the execution of the clinical development plan, specifically the clinical studies defined therein. The CTL leads the Clinical Team, ensuring that the clinical development strategy is executed according to the adequate processes and with the highest clinical and medical scrutiny.
The candidate will report to the Clinical Franchise Leader for Influenza and RSV and will in principle be responsible for projects in Influenza.
However, at Global Clinical Sciences we work in a flexible model and the candidate’s responsibility could be extended to other vaccine areas within Sanofi Pasteur.
The candidate will have a medical degree or a PhD in a life-science area like Biology, Immunology, Pharmacology, etc. Expertise in immunology, specifically in the clinical development of preventive vaccinology is favorable. The candidate should have excellent oral and written communication skills in English.
This exciting role will afford candidates the opportunity to be intimately involved in clinical strategy, and all stages of operational clinical development.
Job Purpose :
- Define the strategic clinical development plan in line with the global R&D strategy, the specific Franchise (commercial) strategy and the Regulatory needs.
- Present, defend and get endorsement of the clinical strategic plan with the appropriate governance committees within Sanofi Pasteur.
- Support the different functions within the Clinical Team with his/her expertise and leadership (monitoring, data management, biostatistics, medical writing, pharmacovigilance, regulatory affairs) as well as interact with and support Project team members, Clinical Immunology Laboratory, Budget and Planning Functions, Legal and Patent Department, Product Brand Leader and Medical Affairs.
- Ensure that the operational development process is aligned with Sanofi Standard Operation Procedures (SOPs), and help to review and improve current SOPs.
- Manage the clinical development process from early stage development until licensure and provide clinical leadership for the generation of evidence from the clinical development data that will support the licensure and commercialization of the new vaccines (e.g. define evidence generation plan, lead interpretation of clinical data, provide decision-making pathways based on study outcomes, provide risk management analyses and mitigation plans etc) .
- Work closely with the pharmacovigilance department to define and ensure the process of safety surveillance during clinical development and design the safety risk management plan.
Key requirements will include:
- Preferred: M.D. with relevant experience or specialization in line with Sanofi Pasteur’s portfolio (Infectious Diseases / Preventive Vaccines), or PhD with a minimum of 3 years’ experience in Clinical Development of Vaccines (Infectious Diseases).
- A background in clinical immunology is welcome
- Experience with working according to GCP/ICH guidelines
- Excellent interpersonal skills, experience with leading and managing transversal teams
- Ability to work in a diverse environment with different stakeholders
- Considerable degree of autonomy
- Ability to act for change, empower themselves and others.
- Good command of oral and written English.
- Take the lead for the preparation of key clinical documents to be prepared for clinical trials (protocols, reports), CTD submissions, interactions with Sanofi Pasteur governance bodies, external experts and committees.
- Build and maintain a strong network of internal and external collaborators, opinion leaders, investigators and competent authorities.
- Support the Global Clinical Sciences department with non-project related activities to continuously improve our way of working, and to maintain our position as center of clinical excellence for Sanofi and with external collaborators.
Sanofi s’engage en faveur de l'accueil et de l'intégration des personnes en situation de handicap.
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.
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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