The Senior Medical Director will serve as the primary medical lead for Karyopharm clinical trials with cross-functional study teams on clinical trial strategy, design and execution. Along with this, the Medical Director will serve as the primary Medical Monitor responsible for monitoring the safety of enrolled subjects on assigned trials. This individual will work on multiple trials in Phases 1 through 3.
- Participates in the development of Study Protocols, Investigator’s Brochures, Clinical Development Plans and other key study documents in conjunction with other line functions and with minimal guidance.
- Serves on cross-functional teams for assigned trials, working with other team members to achieve efficient, high-quality study execution.
- Participates in the preparation of regulatory documents in support of regulatory submissions, including clinical section of IND’s and CTA’s, IND safety reports and annual reports for assigned trials, responses to regulatory authorities and Ethics Committees/IRBs, and other documents as appropriate.
- Provides scientific and clinical input to study-related documents and analysis plans including Informed consent forms (ICF), clinical research forms (CRF), statistical analysis plans (SAP), clinical pharmacology analysis plans (CPAP), and clinical study reports (CSR).
- Acts as liaison between Clinical Development and other internal groups at Karyopharm (e.g., Regulatory Affairs, Clinical Operations, Clinical Data Management) for assigned studies.
- Represents Karyopharm to outside medical personal in the development of clinical protocols and study conduct.