Senior Clinical Research Scientist (Medical Data Review)

Role Overview & Key Functions:

The Senior Clinical Research Scientist (CRS) position serves a key role within the Clinical Development R&D team.  The Senior 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.

• 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
• Thorough understanding of assigned protocol and protocol requirements
• 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 review clinical study reports (CSRs)
• Contribute to review of Regulatory Documents (e.g., IB, Briefing Books) 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.)
• 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

Candidate Profile & Requirements:

• Degree in Life Sciences (advanced degree preferred)
• 5+ years of pharmaceutical Clinical Research experience with at least 1 year experience in biotech
• Comprehensive knowledge of oncology drug development process preferred. 
• 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

 

Our Value Proposition:Groundbreaking Science. Boundless Opportunity. Work Fit for Life. 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 support, flexibility, and a shared mission. Creating and delivering medicine for cancer can only be done through focus, dedication, and heart. We hire exceptional people and trust each other to work in whatever way lets us, be us - whether that's onsite, from home, or anywhere in between.  What do you get when you pair an extraordinary mission with a culture of flexibility and empowerment? We invite you to find out and join us on this incredible mission.

 

Check out our Culture Video!

 

What We Offer:

 

In addition to our exciting, supportive, and intellectually challenging global workspaces(s), teamembers enjoy a comprehensive and generous benefits package (active on day one) that makes them more productive and contributes directly to the development of their professional skills.

• A culture of employee engagement, diversity, and inclusion
• Competitive salary, bonus, and generous equity offerings (RSU's at time of offer and annual awards) - we are partners in prosperity!
• 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

Employment Type: OTHER