Director, Clinical Project Management
Informations Generales :
Location : Montrouge
Collective agreement : Industrie Pharmaceutique
Direct supervisor (Title) : VP, Clinical Operations
Missions Du Poste:
- Manage at the Operational and Scientific level complex and multiple Programs and Clinical Studies of DBV Technologies: design, planning and execution in the selected countries.
- Manager of junior staff in the Clinical Operations Department as needed
Activité Principale:
GCP Activities
- Contribute to the development and implementation of strategic direction in the conduct of multiple clinical studies up to the BLA/MAA of products in DBV’s pipeline
- Responsibilities include providing oversight to ensure clinical trials are conducted in accordance with the protocols, Standard Operations Procedures (SOPs), Good Clinical Practices (GCPs), and other regulatory requirements, selecting, leading and directing Clinical Operations teams in the management of contract research organizations (CROs) and other trial vendors.
- Accountable for the oversight of Strategic Partners and other vendors to meet DBV’s obligations described in ICH-GCP and DBV’s business objectives
- Provides oversight on the development of study documentation including clinical trial protocols, amendments, study plans, information leaflets, IB, eCRFs, ICFs etc.
- Accountable for the review and expert clinical operations input into clinical documents related to the drug development process including Investigator Brochures,
- Investigational New Drug Applications (INDs) and/or Investigational Medicinal Product Dossier (IMPDs), study synopsis protocols, clinical study reports, applicable sections of the Biologics License Applications (BLA), New Drug Application (NDA) and/or Marketing Authorization Application (MAA), and updates to IND and NDA documents; Provide expert clinical operations input into preparation for key regulatory meetings (e.g. End-of-Phase 2 and 3 Meetings, Request for Scientific Advice Meetings, etc.), as appropriate.
- Perform and document study level Sponsor Oversight of outsourced clinical activities
Non GxP Activités :
- Accountable for operational delivery of all clinical trials within program lifecycle, overseeing cross-functional alignment, budget, and timeline from protocol generation through completion of the clinical study report, ensuring quality and a focus on inspection readiness throughout
- Proactively identifies study and program risks and implements contingency plans, providing regular updates on study status to VP of Clin Ops
- Tracks key performance indicators and departmental metrics for Clinical Trial Management and identifies opportunities to optimize processes and procedures (SOPs, Work Instructions)
- Financial reporting to the Head of Clinical Operations on managed programs.
Missions:
- May provide oversight and mentorship to Clinical Trial Managers and Clinical Trial Associates by providing clinical operations and functional area expertise and support identification and prioritization of study and program level work
- Assist the Head of Clinical Operations in the strategy of Organization and Development of the Clinical Operations Department
Internal and External Relations:
- Implementation of procedures in collaboration with the QA department of DBV
- Strong collaboration and partnership with cross functional colleagues (Clinical Development, Project Management, PVE, Regulatory, Biometrics, Medical Affairs, etc) to ensure on-budget, timely, high quality delivery of the studies.
- Contribute to the supervision and safety assessment of patients participating in clinical studies, in partnership with the Medical Department
- To collaborate with and guide the various internal and external partners of DBV towards the concrete realization of Clinical Studies.
- Initiate or develop contacts with external KOLs
Compétences requises:
Technical / scientific skill :
- Proven Autonomy in Project Management
- Knowledge and experience of GCP/ICH practice, and the regulatory and ethical environment of Clinical Studies
- Scientific rigor, ability to analyze, interpret, write and report
- Excellent oral and written communication tools, especially in English, where fluency in oral and written practice is required.
Behavioral skills :
- Curiosity : Keep on exploring uncharted territories. Always ask “why?” and more importantly “why not?”,
- Courage: Take smart risks, mentor each other to always do better & be accountable for our choices, our opinions, and our actions,
- Collaboration: Teamwork and spirit. Support each other and be equally involved in the achievement of our common goals,
- Credibility: Be transparent, follow through and build trust. Educate ourselves about our unique technology.
Formation Initiale:
PhD or PharmD or MD, or MSC
Expérience professionnelle:
- Proven experience and successful management of international/global clinical studies
- Employee management, leadership
- Experience in Allergy, Asthma, Immunology, Immunotherapy, or in related therapeutic areas such as Gastroenterology, Dermatology or Pediatrics.
- Experience of having worked and evolved with ease in a multicultural and cross-functional environment
- Leadership, positive and effective communication with external clinical partners, including CROs, and with internal teams and departments
