Immediate full-time position for a Clinical Development Manager to analyze date from clinical studies and work with biostatisticians to determine relevant clinical correlations with outcomes and patient management. This is a multi-functional role requiring an individual who is 1) capable of mining data, generating clinical study reports and assisting in clinical trials protocol development 2) Researching relevant scientific literature and assisting in clinical trials protocol development. 3) Contributing to regulatory agency and scientific writing activities in conjunction with other team members. Candidate must be comfortable with, and thrive in, an entrepreneurial environment which necessitates a hands-on approach at all levels.
This role will work within the Clinical Development department which will include overseeing the performance of CROs and other vendors, developing/maintaining relationships with clinical collaborators, analyzing clinical data and presenting at conferences and scientific meetings. Also, in partnership with Regulatory, Quality, & Commercial Operations, the Clinical Development Scientist will contribute to regulatory submissions, external communications, designing clinical trial protocols with KOLs and serve as a subject matter expert (SME).
Responsibilities and Duties:
o Partners with data management, assay development and clinical teams for CRF design, instructions,
data review plan and conducts frequent clinical data listing review
o Partners with biostatisticians and appropriate stakeholders to monitor and direct statistical analysis
plan review and finalization
o In conjunction with study medical monitor, creates and/or reviews slides for internal and external
meetings such as investigator meetings. SIVs, company-wide meetings
o Participates in long-term clinical development and planning a pathway to regulatory registration for
assigned diagnostic area(s)
o Serves as clinical science representative on cross-function teams as assigned
Masters degree in life sciences or equivalent combined education and experience.
5+ years of experience in Clinical Development of medical devices or IVDs related to oncology
Expertise in oncology required demonstrated by:
Experience closing an oncology clinical study and authoring an oncology clinical study report
Experience working with PHI and/or communicating with practicing oncologists
Minimum of 3 years of clinical trial experience in oncology
Demonstrated ability to communicate clear, complete, and succinct summaries from complex and potentially contradictory primary literature sources.
Excellent presentation skills. Ability to incorporate complex scientific and clinical data and clearly explain to diverse audience.
Biological Dynamics is an equal opportunity employer.