Clinical Scientist - Immuno-Oncology in Waltham, MA at APEX Systems

Date Posted: 10/12/2019

Job Snapshot

Job Description

Job #:  965506
Clinical Scientist 965506
Job Scope & Purpose: 
Our client, a high profile immune-oncology focused company preparing to enter the clinic, is seeking an experienced clinical scientist with knowledge of I/O programs and an ability to thrive in a dynamic environment! This individual will be responsible for providing scientific support in a cross-functional capacity. The responsibilities include assembling, evaluating, and presenting scientific and medical data and literature. Responsibilities will also include biomarker analysis, evaluation of clinical outcome measures, data review and trial startup activities. Preferred candidates will have the desire to proactively participate within a cross-functional team of internal and external colleagues, CRO partners, experts, and investigators. The successful candidate will work with the company’s talented team to discover and develop therapies that stimulate immune responses against solid and hematologic cancers.
Primary Job Responsibilities:
  • Assist Medical Director and/or interface internally and externally as the clinical science lead in support of a given study or program
  • Participate in authoring key clinical study documents including Protocols, Clinical Study Reports, Investigator Brochures, and Regulatory Authority briefing books
  • Support the creation of and/or review of clinical presentations for internal and external meetings not limited to Investigator Meetings, SIVs, Advisory Boards or Steering Committee Meetings
  • Assist in the collection and compilation of data and coordinate review/submission to scientific meetings for abstracts/posters and other publicly distributed materials
  • Perform clinical review of data listings and essential study data within generated statistical reports and other available data surveillance tools in partnership with Data Management
  • Attend Safety Review Meetings and track or analyze any potential safety event within a given study and across studies in conjunction with Safety
  • Draft the study clinical narratives as needed for health authority submissions and for final Clinical Study Report

Primary Job Requirements:
  • MD, Ph.D. or PharmD, or equivalent with clinical research experience
  • At least 5 years of technical/operational experience in planning, executing, reporting and publishing clinical studies while collaborating with clinical investigators and medical experts
  • Strong scientific background, with clinical and/or research experience in immuno-oncology
  • Comprehensive understanding of the drug development process in all phases of testing
  • Familiarity with pharma/biotech clinical operations and conduct of research collaborations, with a thorough understanding of ICH, GCP, and relevant regulatory requirements
  • Excellent verbal, written, and interpersonal communication skills
  • Willingness to travel up to 30%

About Stratacuity:
Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.
PROVEN SCIENTIFIC PLACEMENT™
 
Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us.
 
jprice@stratacuity.com
 
Code: ClinOps
 
 
 
 
 
 
 
 
EEO Employer
Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178-6178.