Pharma/Biotech Recruiters - Helping Candidates and Companies Ascend!
Our client, a global pharmaceutical company located in northern New Jersey (Morris county) is in search of the following professional.
Dir to Ex Director Global Clinical Leader:
Provides clinical leadership and responsible for all clinical deliverables within the assigned section of a clinical program with minimal supervision from Global Clinical Program Head (GCPH).
Manages all operational aspects and drives execution of the section of the clinical program in partnership with global line functions, assigned Clinical Trial Heads (CTHs), and regional/country medical associates.
Supports GCPH and frequently lead interactions with external stakeholders (e.g., regulatory authorities, key opinion leaders, advisory boards, patient advocacy groups), internal stakeholders (e.g., Research, Exploratory Development, Early Clinical Development, Global Medical Affairs, Marketing, HE&OR), and internal decision boards.
Supports GCPH in ensuring overall safety of the compound in collaboration with the Brand Safety Leader for the assigned program section.
Leads development and ensures implementation of across-program specific standards (e.g., CRFs, outsourcing specifications, data monitoring and validation plans, analysis plan) for all trials to ensure consistency within the program section and across the entire brand.
Leads development of clinical sections of program level regulatory documents such as Investigators’ Brochures, briefing books, safety updates, IND/NDA submission documents, responses to Health Authorities questions with minimal input from GCPH.
MD with advanced knowledge in one or more of these medical/scientific areas (Oncology, Hematology, Endocrinology). Advanced knowledge in clinical research or drug development in an academic or industry environment spanning clinical activities in Phases I through IV. Strong understanding of operational aspects of all phases of clinical trial conduct (Start up, Conduct, Close out).