Senior Medical School Admissions Consultant
InspiraFarms Cooling
Salary
💰 $190,320 - $285,480 per year
Job Level
Lead
About the role
- Support development of individual trial protocols in view of clinical development plan Support the development of case report forms, perform medical monitoring, liaise with investigators and site personnel, perform preliminary and exploratory data analyses on clinical trials, author clinical study reports, provide input on publication materials, and participate in advisory boards Drive and monitor quality of all clinical documents (e.g., protocols, study reports, Investigators’ Brochures, clinical components of regulatory submissions, safety documents) Support/lead creation/review of clinical components of key documents, clinical and regulatory documents, annual safety updates, and registration dossiers (ie, protocol, ICF, IB, annual safety updates, study reports, regulatory submissions [Briefing documents, IND, Clinical dossiers] for registration, market access, and commercialization of the compound(s) Support oversight of the safety of the drug, including the safety aspects of patients in clinical studies and signal detection Support the development of other relevant medical deliverables: concept sheets, briefing books, and label and marketing application dossier, clinical development plans Contribute to the development of the program strategy for assigned trials/compounds Support creation, integration, and execution of overall medical strategy of assigned clinical development programs Contribute to publication and clinical communication strategy in coordination with Scientific Communications; provide input to key external presentations Support interaction with key opinion leaders to ensure implementation of the latest clinical and medical thinking and guidelines into clinical development plans, as well as consideration of novel methods of development Attend relevant congresses or other relevant fora to maintain up-to-date scientific/medical knowledge
Requirements
- MD or equivalent (e.g. MBBS) degree Minimum of 1+ years of directly related industry experience within oncology or hematology Experience representing team and organization in a variety of internal/external settings Proven performance in earlier role/comparable role Prior experience in biotech/pharmaceutical company preferred Prior clinical trial medical oversight experience preferred Prior clinical / academic experience in hematology/ oncology Therapeutic area knowledge/ experience for the role Team Player
