Karyopharm Therapeutics Inc. Senior Medical Director, Clinical Development and IST in Newton, Massachusetts
The Senior Medical Director will serve as the primary medical lead for Karyopharm Independent Research studies. S/He will support and inform the IST strategy, support data analysis, support and review all publications, as well as support NDA activities as needed.
• Review and contribute to all company publications.
• Join the publications team to inform and support strategy
• Support all oral and poster presentations.
• Support NDA activities across the programs
• Review the IB and related regulatory documents
• Support commercial organization at Ad Boards and meeting with medical director support.
• Participates in independent research study calls, as needed
• Responsible for monthly review of safety queries and monthly reporting from independent research studies. The MD will be responsible for raising safety trends or issues on independent research programs to the executive leadership team and ensuring that the internal teams are aware of safety trends across the independent research portfolio
• MD is responsible for representing the independent research program at monthly safety signaling meetings
• MD will serve as the initial escalation point for patient related questions or concerns raised by independent research sponsors and investigators
• Collaborates with Medical Science Liason (MSL) and Clinical Project Manager (CPM) to ensure support for independent research studies
• Key stakeholder reviewer on all independent research protocols, amendments, and informed consent documents.
• Attend CME programs to understand new data and represent KPTI
• Leverage independent research data to inform the company sponsored trial (CST) strategy
• May serves as the medical director on collaborative research engagements, including large cooperative group studies and CTEP initiatives
• Responsible for understanding and presenting, in context, all independent research study data
• Sit on the review committee to evaluate all proposals
• Support the independent research strategy and be a key face for physicians to interact with for medical discussions
• Strong presentation skills, including ability to prepare comprehensive presentations, for internal and external use
• Work collaboratively, effectively, and efficiently with all internal functional groups
MD, DO or equivalent ex-US medical degree (non-MD candidates with doctoral degrees may be considered if they have an appropriate background).
Minimum of 10 years clinical research experience in an academic or industrial setting, with experience in analysis of research data and publications.
Excellent oral and written communication skills
Ability to work collaboratively in a fast-paced, team-based matrix environment and to function independently as appropriate
Karyopharm Therapeutics is a clinical-stage pharmaceutical company focused on the discovery and development of novel first in-class drugs directed against nuclear transport targets for the treatment of cancer and other major diseases.
Street: 85 Wells Ave.