Global Clinical Department Strategy Expert

** About the job*
* As Global Clinical Development Strategy Expert within our Global Clinical Development Department, you will be a key member of the Project Team and Clinical Team, responsible for clinical development strategy and execution. You will primarily focus on clinical trials in the context of Acne therapeutic vaccine development and New Targets projects, though responsibilities may extend to other vaccine areas within Sanofi's flexible model.

You will lead the Clinical Team to ensure that clinical development strategy is executed according to adequate processes with the highest clinical and medical scrutiny. Ready to get started?

** About Sanofi:*
* We're an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system - and innovative pipeline - enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people's lives.

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* Key Responsibilities:

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* + Define the strategic clinical development plan in line with global R&D strategy, franchise strategy, and regulatory needs, and present for endorsement with appropriate governance committees

+ Lead the Clinical Team and support different functions (monitoring, data management, biostatistics, medical writing, pharmacovigilance, regulatory affairs) with expertise and leadership

+ Manage the clinical development process from early-stage development through licensure, providing clinical leadership for evidence generation that supports licensure and commercialization

+ Work closely with the pharmacovigilance department to define safety surveillance processes during clinical development and design the safety risk management plan

+ Lead preparation of key clinical documents for clinical trials (protocols, reports), CTD submissions, and interactions with governance bodies, external experts, and competent authorities

+ Ensure operational development processes align with Sanofi Standard Operating Procedures and help review and improve current SOPs

+ Build and maintain a strong network of internal and external collaborators, opinion leaders, investigators, and competent authorities

** About you*
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* Experience:

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* + MD with specialization in Dermatology, Infectious Diseases, Pediatrics, Internal Medicine, or related field; or PhD in a life science area (Biology, Immunology, Pharmacology, or related field) with extensive clinical development experience.

+ 5-10+ years of experience in clinical development with demonstrated expertise in vaccine or therapeutics development and clinical strategy in academia, non-profit, government or industry.

+ Experience working according to GCP/ICH guidelines.

+ Proven ability to lead and manage transversal teams with excellent interpersonal skills.

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Experience with regulatory submissions and interactions with health authorities.

** Technical and

Soft Skills:

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* + Background in clinical immunology is welcome.

+ Expertise in Dermatology, Infectious Diseases, Pediatrics, or Internal Medicine preferred.

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Experience with therapeutic vaccines, particularly for dermatological conditions such as Acne, and any later stage development is highly valued.

+ Excellent oral and written communication skills in English.

+ Considerable degree of autonomy with ability to act for change and empower others.

+ Ability to work in diverse environments with different stakeholders

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* Languages:

** Excellent command of oral and written English

_Join the engine of Sanofi's mission - where deep immunoscience meets bold, AI-powered research. In R&D, you'll drive breakthroughs that could turn the impossible into possible for millions_

+ Work at the forefront of drug discovery, harnessing cutting-edge AI, data, and digital platforms to push the boundaries of science.

+ Help improve the lives of millions of people globally by making drug development quicker and more effective.

+ Enjoy opportunities to collaborate beyond your area of expertise, working with diverse teams across science, clinical, and digital fields to spark new ideas and drive breakthroughs.

+ Accelerate your…