Job Title:Clinical Scientist - 100% Remote
Duration: 12 months
Purpose:
In collaboration with a therapeutic area Medical Director or Scientific Director, the Clinical Scientist will contribute to the design, conduct, analysis, and reporting of clinical trials. The Clinical Scientist will apply scientific training and clinical research experience to support all aspects of drug development, from facilitating the transition of molecules from pre-clinical discovery to supporting the registration and commercialization of a product.
Responsibilities:
Contribute to the review, interpretation and communication of scientific data pertaining to the efficacy and safety of compounds in development. Attends congress and reviews the literature to develop and augment expertise in therapeutic area
Help develop program strategy including the clinical development plan, product lifecycle plans, target product profiles and draft labels. Reviews competitive landscape and help identify and evaluate business development opportunities.
Responsible for providing focused scientific and clinical study support from start-up clinical study report (CSR).
Participate in scientific education of internal and external stakeholders on the pre-clinical (e.g. mechanism of action, animal models) and clinical (e.g. epidemiology, diagnosis, treatment) data relevant to program. Engage opinion leader interactions to build pipeline awareness and foster research collaborations.
Contribute to the scientific content of Study Protocols, Investigator Brochures, Clinical Study Reports, Informed Consent Forms, briefing documents, charters, and regulatory documents.
Contribute to creation of electronic database, IRT, and associated training documents and review data completeness and fidelity throughout study conduct.
Collaborate cross-functionally to help create a scientific platform in support of the regulatory, commercial and medical education strategy for late-stage assets.
Ensure adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research. Contributes to authorship of regulatory responses and may participate in meetings.
Qualifications:
Bachelors degree in the sciences; advanced degree (e.g., MS, PhD) preferred.
Ability to provide input and direction to clinical research with appropriate supervision
Experience in rheumatic diseases especially lupus is preferred.
Strong desire to collaborate in a cross-functional setting.
Clinical trial experience in the pharmaceutical industry, academia, or equivalent is preferred.
Knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials and experience in the design of study protocols.
About Us:Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCEis built on a concept of human connection, defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at:http://www.spectraforce.com
Benefits:SPECTRAFORCEoffers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCEprovides unpaid leave as well as paid sick leave when required by law.
Equal Opportunity Employer:SPECTRAFORCEis an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources atLOA@spectraforce.comif you require reasonable accommodation.
California Applicant Notice:SPECTRAFORCEis committed to complying with the California Privacy Rights Act (CPRA) effective January 1, 2023; and all data privacy laws in the jurisdictions in which it recruits and hires employees. A Notice to California Job Applicants Regarding the Collection of Personal Information can be located on our website. Applicants with disabilities may access this notice in an alternative format by contactingNAHR@spectraforce.com.
LA County, CA Applicant Notice:If you are selected for this position with SPECTRAFORCE, your offer is contingent upon the satisfactory completion of several requirements, including but not limited to, a criminal background check. We consider qualified applicants with arrest or conviction records for employment in accordance with all local ordinances and state laws, including the Los Angeles County Fair Chance Ordinance for Employers (FCO) and the California Fair Chance Act (FCA). The background check assessment will consider whether a criminal history could reasonably have a direct, adverse impact on the job-related safety, security, trust, regulatory compliance, or suitability for this role. Such findings may result in withdrawal of a conditional job offer.
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