Clinical Scientist, Clinical Development

Of immediate need to BioDyn is a full-time Clinical Scientist for Clinical Development to analyze date from clinical studies and work with biostatisticians to draw conclusions which lead to scientific publications.  This is a hands-on role, requiring an individual who is 1) capable of designing and 2) able to write academic publications in collaboration with team members. Our ideal candidate must be comfortable with, and thrive in, an entrepreneurial environment which necessitates a hands-on approach at all levels.

 General Summary:

This role will work within the Clinical Development department which will include innovating experiment designs for oncology and other disease states, driving and overseeing the performance of CROs and other vendors, developing/maintaining relationships with clinical collaborators, and presenting clinical data at conferences and scientific meetings.  In partnership with Regulatory, Quality, & Commercial Operations, the Clinical Scientist will contribute to regulatory submissions, external communications, interact with KOLs and serve as a subject matter expert (SME).

Responsibilities and Duties:

  • Scientific writing: Authors or contributes to production of high-quality documents or sections that are scientifically sound:

o    Clinical protocols and amendments

o    Clinical study reports

o    Investigator brochure

o    Documents to support health authority interactions including DSURs

o    Publications including abstracts and congress presentations

  • Translating biomarkers: Supports development of biomarkers from development into research and clinical applications. Schedules and supports the clinical development of assays.

  • Decision quality data generation:

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

  • In conjunction with study medical monitor creates and/or reviews slides for internal and external meetings such as investigator meetings, SIVs, company-wide meetings

  • Participates in long-term clinical development and planning a pathway to regulatory registration for assigned diagnostic area(s)

  • Serve as clinical science representative on cross-function teams as assigned

Education/Experience/Skills:

  • PhD (or equivalent) degree in life sciences or related fields.

  • 5+ years of experience in Clinical Development of medical devices or IVDs

  • Minimum of 3 years of clinical trial experience in industry;

  • Experience closing a clinical study and authoring a clinical study report

  • Prior experience working with PHI and/or communicating with practicing oncologists is desirable

  • 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.

  • Expertise in oncology strongly preferred

Core Competencies:

o    Ability to thrive in a fast-paced, hands-on entrepreneurial environment;

o    Effective at planning, organizing, and prioritizing;

o    Able to handle multiple tasks and deliver high quality results under tight timelines;

o    High attention to detail and accuracy;

o    Effective troubleshooting and problem-solving skills;

o    Flexible and adaptable to change;

o    Adept at building strong relationships and collaborating with colleagues at all levels;

o    Highly collaborative, self-motivated, and team-oriented;

o   Effective communicator in both oral and written form

o   Strong interpersonal skills and ability to work effectively across multiple multidisciplinary teams

 Additional Information:

Biological Dynamics is an equal opportunity employer.