Reference Number: JO-1908-435613
Director of Clinical Development
Job Type: Permanent
Location: United States
CPL Physicians is working with a growing biotech business researching novel gene therapies for rare and orphan disease and they are searching for a talented and passionate Director of Clinical Research to be based in New Jersey or Philadelphia.
The Director, Clinical Research Gene Therapy, is expected to have a key role in the generation of the Clinical Development Plan and to elaborate the protocols that will lead to a successful submission of novel Gene Therapy diseases. In this area of Gene Therapy treatments of lysosomal storage diseases, the Director, Clinical Research will collaborate with peers in the Development Organization to optimize the strategy of the company and to implement, execute, analyze and report the clinical studies into global submissions.
Roles and Responsibilities
Contributing to the Clinical Development Plan (CDP) preparation for the GT clinical programs.
Implementing the development strategy for the GT clinical programs from early phase studies up to the global submissions and beyond.
Providing hands on tactical work, in project teams and working in collaboration with relevant team members and peers to ensure the highest level of execution for the GT clinical program.
Working with Clinical Trial Investigators and clinical research organizations, to collaborate on trial site selection, training and ongoing conduct of the study.
Acting as lead medical monitor for the GT clinical programs, conducting site visits as needed, having detailed understanding of patient level data.
Ensuring that studies are performed with the highest quality. Performing data review and analysis, presentations (oral and written) of clinical data, authoring and editing of clinical study reports.
Participating in preparation of regulatory documents (e.g. Investigator Brochures, CSRs, Briefing documents) and in face-to-face meetings with the regulatory agencies.
Perform all responsibilities in compliance with company policies, SOP and guidelines.
Qualifications and Background Requirements
Medical Doctors (MD) degree and post residency training is required
Completion of a residency in either pediatrics or internal medicine and, preferably, a fellowship in a related sub-specialties area (e.g. neurology, genetics).
Significant experience practicing medicine is a plus
Experience with rare and/or orphan diseases is highly desired. Knowledge of lysosomal storage disorders a significant plus.
Experience in drug development in pediatric populations is a significant plus.
A drug development professional with experience derived from a career in a significant biotechnology or biopharmaceutical company environment; a key role in the submission of several successful NDA/BLA and/or MAA is preferred.
Experience in pharmacovigilance processes in the conduct of GT studies and patient follow-up post-GT.
Experience on teams with early and late stage development products.
Must be passionate about developing treatments for patients with rare/orphan diseases.
For more information on this role please CLICK APPLY and forward an up to date resume.