Karyopharm Therapeutics Inc. · 18 hours ago
Senior Director, Clinical Research Scientist
Newton, MA
Full-time
Hybrid
Director/Executive
12+ years expKaryopharm Therapeutics Inc. is focused on pioneering novel cancer therapies and is seeking a Senior Director, Clinical Research Scientist to play a key role within their Clinical Development R&D team. The role involves supporting clinical studies, collaborating with various teams, and ensuring high-quality deliverables throughout the research process.
Health CareMedicalPharmaceutical
Responsibilities
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.)
Provides mentoring to more junior clinical researcher scientists as needed based upon 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
Qualification
Required
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 of GCP/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
Benefits
A culture of employee engagement, diversity, and inclusion
Competitive salary, bonus, and generous equity offerings (RSU’s at time of offer and annual awards)
Peace of mind through best in class medical (deducible paid by KPTI), dental, vision, disability, and life insurance, parental leave, a matching 401k program (immediate vesting), ESPP and tuition reimbursement
Wellness Program with a monthly stipend
Generous PTO and Holidays – we encourage you to recharge and spend time with family and friends
Ample opportunities to learn and take on new responsibilities in a fast-paced, and patient focused company. (tuition reimbursement, management development & mentoring programs, and a variety of reward and recognition programs)
Cell phone allowance
Company
Karyopharm Therapeutics Inc.
Karyopharm Therapeutics Inc.
201-500 employees
H1B Sponsorship
Karyopharm Therapeutics Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (8)
2024 (2)
2023 (10)
2022 (8)
2021 (5)
2020 (10)
Funding
Current Stage
Public CompanyTotal Funding
$607.2MKey Investors
Avidity PartnersForesite CapitalDelphi Ventures
2025-10-08Post Ipo Equity· $33M
2025-10-08Post Ipo Debt· $27.5M
2022-12-05Post Ipo Equity· $165M
Leadership Team
Brian Austad
Senior Vice President, Pharmaceutical Sciences
Sohanya Cheng
EVP, Chief Commercial Officer & Head of Business Development
Recent News
2025-11-08
Company data provided by crunchbase