Clinical Trial Manager (Paris)
We are a gene therapy company changing lives with every genetic advancement.
Asklepios BioPharmaceutical, Inc. (AskBio) is a leading, clinical-stage gene therapy company founded in 2001 based on the work of adeno-associated virus (AAV) gene therapy visionary and pioneer, Jude Samulski, PhD. Since that time, our commitment to developing life-saving medicines that cure genetic diseases has never wavered.
As the only end-to-end gene therapy company in the industry, we’ve built a foundation of therapeutic programs, AAV manufacturing and a rich portfolio of patented technology. Our therapeutic focus includes neuromuscular, central nervous system, cardiovascular and metabolic diseases with clinical trials underway for Pompe disease, Parkinson’s disease and congestive heart failure. Our gene therapy platform includes Pro10™, an industry-leading proprietary cell line manufacturing process, and an extensive AAV capsid and promoter library.
We became a wholly owned, independently operated subsidiary of Bayer AG in late 2020 as a cornerstone of its newly formed Cell & Gene Therapy Platform. Our global headquarters are in Research Triangle Park, North Carolina, a thriving biotechnology hub, and we maintain additional research and development operations in Scotland and France and gene therapy manufacturing in Spain.
We have an opportunity for a Clinical Trial Manager (CTM) to join the AskBio team in our Paris, France location and be part of our continued success! Candidates with extensive experience and exceptional leadership qualities may be considered at Associate Director or Director level.
About the role
The Clinical Trial Manager (CTM) will be responsible for the feasibility assessment, protocol development, planning, execution and leadership of regional and global clinical trials at AskBio. As a core member of the global product development team, the CTM will lead cross-functional clinical operations teams with members from medical safety, site management, clinical supply management, data management, biostatistical programming and medical writing to successfully operationalize the trial, achieve the key milestones, and ensure compliance with ICH-GCP and regulatory guidelines. The CTM will partner with the project leader and project manager and work closely with investigators, study site staff and vendors to manage enrollment targets, timelines and risks.
Responsibilities and accountabilities
- Serve as core team member on project teams and work with project manager to develop trial plans and budgets
- Work with project/program head and project manager to crystallize the objectives and milestones of clinical trials
- Partner with relevant functions to prepare budgets for clinical trials and achieve the objectives and reach the milestones within the budget and timelines
- Conduct feasibility assessments of planned clinical trials, including assessments of competition and the selection of study endpoints
- Develop full trial protocol after the trial synopsis is finalized and key elements of the trial are decided
- Provide oversight to clinical vendors and CROs assigned to CNS and other studies
- Act as the main line of communication between AskBio study team and the investigator/site/CRO for scientific, medical and strategic activities
- Lead the development of investigator and site subject area and protocol training
- Review patient screening data and approve subjects for randomization/dosing
- Provide oversight to confirm the timely reporting and review of serious adverse events by the investigators
- Qualify and oversee external vendors that provide clinical research services
- Attend all team meetings and serve as a primary point of contact for communication between the project team and CRO or investigational sites
- Assess, communicate and manage the risks associated with the clinical trial plan
- Communicate progress and milestone status to leadership, R&D partners and others
- Organize multi-disciplinary team and engage necessary disciplines to address trial goals and objectives
- Work cross functionally to assess project risks, product safety and efficacy on projects
- Provide input and reviews for study protocols and reports from clinical studies
- Identify external labs (academic, CRO) and route requests of investigator-initiated clinical studies to global medical affairs staff
- Participate in reviews and provide recommendations for business development opportunities
- Perform other activities as assigned by the Therapeutic Sector Leader, Head of Clinical Operations and senior management
- BS or BA in life sciences or a nursing degree, advanced degree in life science and health care (MD, PharmD, PhD) with neurology background are desired; experience within the gene therapy field would be a plus
- At least three years of global clinical research experience in academia, pharma, biotech or contract research organization
- Familiar with ICH-GCH guidelines and regulatory requirements of clinical trial design, implementation and reporting
- Trained with relevant GCP SOPs and clinical trial quality framework
- Demonstrated ability to efficiently work with different personalities and styles and prioritize activities based on ambiguous or quickly changing information and environments is critical
- Ability to multitask among multiple teams and work independently in a fast-paced, highly interactive environment
- Excellent interpersonal skills with the ability to interact effectively with people, internally and externally is required
- Track record of successful engagement with CNS key opinion leaders and industry experts
- Native French speaker with fluency in English
Candidates must have a valid right to work in France, work permit or Visa.
For a confidential discussion or to submit your application, please contact firstname.lastname@example.org.
Live an AskLife™
We offer a competitive total rewards package. Are you our next great discovery?