Clinical research md

Le contenu du poste est libellé en anglais car il nécessite de nombreuses interactions avec nos filiales à l’international, l'anglais étant la langue de travail.

This job offer is accessible to all, regardless of gender.

Job title: Clinical Research MD

* Location: Gentilly, Campus Val de Bièvre


About the job


The Development Medical Director (DMD) is a key clinical lead in the Development of R&D programs.The role requires a well-organized, strategically, operationally focused, resourceful individual with very good emotional intelligence, self-motivation, solid analytical skills, and the ability deliver to multiple operational tasks.

The role of the DMD is to:

* Collaborate with other medical and clinical scientific experts DMDs or DSDs in the project under the leadership of the Global Project Head, with the Global safety Officer, Regulatory Strategist and other key functional representatives to deliver development strategy and prepare/assist with regulatory bodies interaction
* Provide clinical scientific expertise in the Study team to conduct the clinical studies from early phases to LCM programs
* Develop the study level regulatory documentation (Abbreviated Protocol, Protocol, Amended protocol) for their project, lead other operational development activities pertaining to study start-up (e.g. pressure test, competitive intelligence, patient engagement, cluster feasibility, study risk assessment etc.)
* Provide appropriate clinical scientific input & support for all activities related to clinical studies conduct such as answers to IRBs and HA questions, protocol scientific and medical training, medical review of data within the scope of the Centralized monitoring, clinical and medical information for the study team, medical advisors/Clinical Project Leaders from Clinical Study Units, and investigators
* Contribute to the clinical part of Common Technical Document for submission to regulatory bodies (FDA, EMA, PMDA etc.) and answer to questions from health authorities
* Be the scientific & medical reference in the Study team, ensuring the medical relevance of the clinical data
* Develop the study level regulatory documentation (Abbreviated Protocol, Protocol, Amended protocol) for their project, lead other operational development activities pertaining to study start-up (e.g. pressure test, competitive intelligence, patient engagement, cluster feasibility, study risk assessment etc.)

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.

Key responsibilities:

Leading the clinical development plan strategies

* Responsible for the clinical development plans and clinical sections of integrated development plans (IDP)
* Collaborate with other DMDs/DSDs within the project, ensures leadership, builds consensus, coordinates action plans with stakeholders to resolve project-related issues, anticipates potential issues (sharing lessons learned) across the project or study teams
* Raise study or project-level issues to the project head and propose related corrective action plans
* Contribute in the definition of the product value proposition (TVP), Target Product Profile (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
* Collaborates with external partners, regulators, scientific experts and internal stakeholders
* Raise study or project-level issues to the project head and propose related corrective action plans
* Evaluates relevant medical literature and status from competitive products

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

* Collaborate and communicate appropriately with all function stakeholders (e.g. clinical operations, project management, Patient Safety and Pharmacovigilance, regulatory, Finance, Scientific External Engagement, Procurement etc.), 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)
* Develop the abbreviated protocol, the final protocol and protocol amendments
* Develop/review the Core Study Informed Consent Form (CSICF)
* Develop/review Study committee Charters
* Collaborate on key medical and clinical questions with the Global feasibility manager to prepare and interpret feasibility and competitive intelligence results
* Review and provide clinical input across different study documents Vendors RFPs, (e-)CRF,( e-)diary, (e- )CoA etc
* Raise study or project-level issues to the project head and propose related corrective action plans
* Participate in the elaboration of training material and presentations at the investigator meetings/local teams trainings
* Answer to medical questions raised by HA, EC/IRBs, sites
* Ensure quality of clinical data through continuous data validation, blinded Data review on summary tables or electronic data visualization during clinical trial conduct (AE dedicated review, and Clinical Case review for safety data and statistical surveillance for efficacy data)
* Raise study or project-level issues to the project head and propose related corrective action plans
* 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
* Raise study or project-level issues to the project head and propose related corrective action plans

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, 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
* Collaborates with the Patient Safety GSO to detect and document any safety signal
* Participates in Advisory Committee preparation

Scientific Data evaluation and authorship

* Participate and author manuscripts and abstracts
* Establish and maintains appropriate collaborations with knowledge experts or advisory boards
* Contribute on an ad hoc basis to specific tasks such as the evaluation of potential in-licensing candidates for the therapeutic area and serves as the clinical advisor to research teams


About you

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
* Excellent problem solving capability
* 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

Minimum Level of any Required Qualifications:

* Medical Doctor (MD); dermatologist/pneumologist is a plus
* At least 3 years previous experience in clinical development in pharmaceutical industry or a CRO or experience in clinical development in an Healthcare institution


Pursue Progress. Discover Extraordinary.

Join Sanofi and step into a new era of science - where your growth can be just as transformative as the work we do. We invest in you to reach further, think faster, and do what’s never-been-done-before. You’ll help push boundaries, challenge convention, and build smarter solutions that reach the communities we serve. Ready to chase the miracles of science and improve people’s lives? Let’s Pursue Progress and 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, gender identity, protected veteran status or other characteristics protected by law.

#LI-FRA

#LI-Onsite

La diversité et l’inclusion sont les piliers de la manière dont Sanofi fonctionne et font partie intégrante des valeurs de la société. Nous respectons la diversité de nos collaborateurs, tout comme celle de leurs parcours et expériences. Afin de bénéficier de la richesse qu’apporte la diversité, Sanofi s’engage à donner l’exemple en matière d’inclusion et à favoriser un environnement de travail où les différences peuvent prospérer et contribuer à aider les patients à retrouver une vie meilleure.

Dans le cadre de son engagement diversité, Sanofi accueille et intègre des collaborateurs en situation de handicap.