Senior Director, Clinical Research Scientist

Senior Director, Clinical Research Scientist

Join to apply for the Senior Director, Clinical Research Scientist role at Karyopharm Therapeutics Inc.

The Sr Director, Clinical Research Scientist position serves a key role within the Clinical Development R&D team. The Sr Director, CRS works closely with the assigned study team(s) and medical director(s) to support the activities associated with one or more clinical studies. This position collaborates with clinical team members as well as with functions outside of clinical to provide high quality and timely deliverables.

Reporting to our Senior Vice President, Clinical Development, you will positively impact patients’ when you:

• Support assigned study level activities for one or more clinical studies.
• Develop thorough understanding of assigned protocol and protocol requirements.
• Support study activities as applicable.
• Liaison between medical monitor, clinical operations, and CRO.
• Participate in the protocol development process; including writing, reviewing, adjudication/resolution of cross‑functional comments, ensuring high‑quality final document.
• Lead the medical data review process during ongoing study, including individual patient review for purposes of data cleaning, and aggregate data review for safety and protocol conduct purposes.
• Participate in the creation of and the review of clinical study reports (CSRs).
• Contribute to the creation of and the review of Regulatory Documents (e.g., IB, Briefing Books, and regulatory submission documents) in collaboration with medical writers with minimal to moderate supervision.
• Review/Edit Master Informed Consent Forms (ICF).
• Active contributor to study committee (e.g., DMC) activities such as charters, meetings, presentation preparation.
• Active contributor to Investigator Meeting and Site Initiation Visit presentations.
• Active contributor to activities related to data generation and validation, including CRF creation, clinical data review, data cleaning, communication as needed to resolve data queries, contribute to development of data review plans, support medical director and pharmacovigilance physicians in data review (generation of reports, action plans, trend identification), etc.
• Provide mentoring to more junior clinical researcher scientists as needed based on past experience and prior understanding of roles and responsibilities.
• Collaborate with study team members (Clinical Operations, Data Management, Statistics, Drug Safety, IMSC, Regulatory Affairs, Translational Medicine and Project Management) to ensure that key milestones are met on time and with high‑quality data output.
• Participate in operational excellence projects as appropriate and audit readiness activities.

• Degree in Life Sciences (advanced degree preferred).
• 12 years of pharmaceutical clinical research experience including prior experience in pharma/biotech.
• Prior experience supporting and participating in regulatory inspection activities.
• Prior experience supporting regulatory submissions including NDA, sNDA or equivalent (outside the US/FDA).
• Comprehensive knowledge of oncology drug development with some direct experience required.
• Proficient knowledge ofCP/ICH, study design, statistics, clinical operations within the oncology therapeutic space.
• Excellent verbal, written, communication and interpersonal skills. Must be able to effectively communicate and collaborate across functions and job levels.
• Proficient knowledge and skills to support program‑specific data review, trend identification, data interpretation.
• Proficient in Medical Terminology and medical writing skills.
• Adaptable / Flexible (willing and able to adjust to multiple demands and shifting priorities; ability to meet day‑to‑day challenges with confidence and professionalism).
• Proficient in Microsoft Word, Excel, PowerPoint, Electronic Data Capture (e.g., RAVE), or similar data reporting tools.

At Karyopharm, we live and demonstrate our ICARE values every day! If you want to do something that matters, this work matters. Patients drive our passion to pioneer novel cancer therapies. That’s why we’ve built an environment centered around…