Director, Clinical Operations Promedior
THIS JOB HAS EXPIRED Reports to: Chief Medical Officer
Education: B.S./M.S. or Ph. D. in Clinical Pharmacology, Biology or related discipline
Experience: Minimum of 15 years of experience. Established reputation in managing clinical trials and regulatory submissions from pre-IND through Phase 3 studies, independently and through CRO
The successful candidate will have an established record in the design, regulatory submission and execution of clinical studies investigating novel thereapeutics related to immune regulation from pre-IND through Phase 3 clinical development. The candidate must be results driven, and make independent decisions on the basis of data using good clinical practice in order to keep projects on track and on time. This person will lead and manage the conduct and oversight of all clinical studies utilizing internal resources and third party CROs. An in-depth understanding of the regulatory requirements for each stage of clinical development of protein therapeutics is essential as is direct experience in authoring and successfully submitting regulatory documents to both the FDA and EMEA. This position requires strong leadership and problem solving skills as well as excellent communication skills in English, particularly with respect to project management, site management and patient recruitment. Ideally, the candidate will have direct experience in pulmonary, oncology and/or ophthalmic IND submission and trial design and execution.
This person will be responsible for determining overall strategy for project development including preparing development plans, administering project and study budgets, and directing and coordinating the operational and logistical activities of clinical operations in the development of products, projects and programs in accordance with SOPs and GCP, ICH and FDA guidelines and established budgets and timelines.
In-depth knowledge of GCP, ICH and both FDA and EMEA guidelines for the investigation and approval of new drug products from IND through BLA/NDA
In-depth knowledge of the issues related to successful clinical operation management including protocol and SOP development, CRO selection, site selection, site monitoring and oversight, clinical data management and accrual, and patient recruitment and retention.
A strong working knowledge of relevant US and European drug development regulations including ICH, with demonstrated experience in successfully authoring and submitting all required regulatory documents through NDA/BLA submission.
Demonstrated capability of proficient written and oral communication skills in English
Ability to work in a small company
The ability to supervise both junior and senior level project managers including coordinating their activities in order to meet company goals and timelines
||Boston, MA |
THIS JOB HAS EXPIRED