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Clinical Research Scientist, Lymphoma Studies

Company: Karyopharm Therapeutics
Location: Newton
Posted on: June 13, 2021

Job Description:

Responsibilities

The Clinical Research Scientist (CRS) position serves a key role within the Clinical Development R&D team, reporting to a Senior Clinical Research Scientist. The 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. The CRS is responsible for achievement of personal goals which support study team, project team, and corporate goals.

  • This position can be performed from a remote location within the US
  • 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

Qualifications

  • Degree in Life Sciences (MD, PhD, PharmD, MS, RN, PA, NP)
  • 2+ years of academic/pharmaceutical/biotech clinical research experience or hematology/oncology patient care experience.
  • 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

Overview

Karyopharm Therapeutics Inc. (NASDAQ: KPTI) is a commercial-stage pharmaceutical company pioneering novel cancer therapies and dedicated to the discovery, development, and commercialization of first-in-class drugs directed against nuclear export for the treatment of cancer and other diseases. Karyopharm's Selective Inhibitor of Nuclear Export (SINE) compounds function by binding with and inhibiting the nuclear export protein XPO1 (or CRM1). Karyopharm's lead compound, XPOVIO (selinexor), is approved in the U.S. in multiple hematologic malignancy indications, including in combination with Velcade (bortezomib) and dexamethasone for the treatment of adult patients with multiple myeloma after at least one prior therapy, in combination with dexamethasone for the treatment of adult patients with heavily pretreated multiple myeloma and as a monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma. NEXPOVIO (selinexor) has also been granted conditional marketing authorization in combination with dexamethasone for adult patients with heavily pretreated multiple myeloma by the European Commission. In addition to single-agent and combination activity against a variety of human cancers, SINE compounds have also shown biological activity in models of neurodegeneration, inflammation, autoimmune disease, certain viruses and wound-healing. Karyopharm has several investigational programs in clinical or preclinical development. For more information, please visit www.karyopharm.com.

Karyopharm Therapeutics Inc. (the "Company") is an equal opportunity employer. All qualified applicants will be considered without regard to age, race, color, sex, religion/creed, national origin, marital status, ancestry, citizenship, military, reservist or veteran status, pregnancy, sexual orientation or preference, gender identity, gender expression, physical or mental disability, genetic predisposition or carrier status, or any other category protected under applicable federal, state or local law. Consistent with its obligations under applicable law, the Company will make reasonable accommodations for qualified individuals with disabilities. If you require an accommodation in the application process, please contact a member of the Company's Human Resources department.

Keywords: Karyopharm Therapeutics, Newton , Clinical Research Scientist, Lymphoma Studies, Other , Newton, Massachusetts

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