Clinical Research MD

Sanofi; Gentilly; Sur place; EUR 70 000 - 90 000; Plein temps

Résumé du poste

Une entreprise biopharmaceutique internationale recherche un Clinical Research MD pour diriger les plans de développement clinique et collaborer avec des experts sur des études. Le candidat idéal a un diplôme de médecin et au moins 3 ans d'expérience en développement clinique. Le poste est basé à Gentilly, avec des interactions fréquentes à l'international.

Qualifications

• Compréhension du développement de produits pharmaceutiques et gestion du cycle de vie.
• Expérience antérieure d'au moins 3 ans dans le développement clinique.
• Compétences en enseignement et formation des autres.

Responsabilités

• Collaborer avec des experts médicaux pour planifier les stratégies de développement clinique.
• Assurer la qualité des données cliniques par une validation continue.
• Contribuer à la rédaction de la documentation réglementaire.

Connaissances

Expertise scientifique et médicale

Compétences en communication

Résolution de problèmes

Travail dans un environnement matriciel

Négociation

Formation

Diplôme de Médecin (MD)

Description du poste

About the job

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

Job role

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 to 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 the 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 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 the Common Technical Document for submission to regulatory bodies (FDA, EMA, PMDA, etc.) and answer questions from health authorities.
• Be the scientific & medical reference in the study team, ensuring the medical relevance of the clinical data.

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, ensuring leadership, building consensus, coordinating action plans with stakeholders to resolve project‑related issues, and anticipating 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.
• Collaborate with external partners, regulators, scientific experts and internal stakeholders.
• Evaluate 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 functional 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 GCP, applicable laws and regulations as well as applicable 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.
• Participate in the elaboration of training material and presentations at investigator meetings/local team 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).
• Lead the study‑specific committees (IDMC, steering committee, adjudication) with operational support.
• Co‑develop the SAP in collaboration with biostatistics.
• Responsible for key results preparation.

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.
• Ensure clinical data meets all necessary regulatory standards.
• Collaborate with the Patient Safety GSO to detect and document any safety signal.
• Participate in advisory committee preparation.

Scientific Data evaluation and authorship

• Participate and author manuscripts and abstracts.
• Establish and maintain 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 serve 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 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 a 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.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!