Senior clinical research scientist job description

• Support assigned study level activities for one or more clinical studies.
• Develop thorough understanding of assigned protocol and protocol requirements
• Support study start-up/conduct/close-out activities as applicable:
• • Preparation, storage, maintenance of clinical documents (TMF)
  • 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
  • Perform medical monitoring duties, with moderate supervision provided by the medical director
  • Participate in review and validation of 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 Informed Consent Forms (ICF); review/edit regional and site ICFs as needed; ensure alignment with protocol
  • Active contributor to study committee (e.g., DMC) activities such as charters, meetings, presentation preparation
  • Active contributor to Investigator Meeting and Site Initiation Visit presentation preparation
  • 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.)
• May support clinical development planning (assist with analysis of data and review of literature to support future planning)
• 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
• Provide guidance and scientific expertise within team, across department, and across functions
• Identify, escalate current/active/future issues; propose and enact solutions
• Strong presentation skills, including ability to prepare and deliver comprehensive presentations to both internal and external audiences

• Degree in Life Sciences (PharmD, MS, RN, PA, NP)

• 5+ years of pharmaceutical/biotech clinical research experience

• Prior Management experience is a plus
• 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.
• Strong sense of teamwork; ability to lead team activities
• Proficient knowledge and skills to support program specific data review, trend identification, data interpretation
• Proficient in Medical Terminology and medical writing skills
• Proficient critical thinking, problem solving, decision making skills
• Understanding of functional and cross-functional relationships
• 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 Karyopharmers live and demonstrate our ICARE Values every day!

#ThisIsWhyKPTI

Karyopharmers are passionately driven in our mission to positively impact patients' lives and defeat cancer! This is personal, and we approach every challenge fiercely and tenaciously, but with enthusiasm, empathy, and passion. The work we do is both inspiring and life-changing. It requires the most diverse, the most unique, and the most authentic team in the industry. We are 400+ cancer driven conquerors, across the globe, with a strong sense of our values and our purpose. We are innovators, disrupters, and collaborators, and we challenge the norm and do things differently. At Karyopharm you will have the opportunity to do well by doing good, while learning and growing along the way. We invite you to join us and make your own personal contribution to our mission!

What We Offer:

In addition to our exciting, supportive, and intellectually challenging global workspaces(s), Karyopharmers 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 fun, collaborative, work environment
• A culture of employee engagement, diversity, and inclusion
• Competitive salary, bonus, and generous equity offerings (Stock options and RSU's-at time of offer and annual awards) - we are partners in prosperity!
• Peace of mind through best in class medical (deductible paid by KPTI), dental, vision, disability, and life insurance, parental leave, a matching 401k program (immediate vesting), and tuition reimbursement.
• 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 programs, and a variety of reward and recognition programs)
• Cell phone allowance

*Karyopharm requires all employees to be fully vaccinated against the Covid19 virus at the time of employment

* This position is eligible for remote/hybrid working arrangement (may work from home/virtually; may also work hybrid on-site-virtual as required/approved by hiring manager.

ABOUT KARYOPHARM

WE ARE COMMITTED TO DE&I